protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT03104699 | 4.4.3 | Premature Discontinuation of the Trial | 4.4.3. Premature Discontinuation of the Trial The entire trial may be discontinued prematurely in the event of any of the following: - New information leading to unfavorable risk-benefit judgement of AGEN2034, e.g., due to: - Occurrence of significant previously unknown adverse reactions, or unexpectedly high intensity... | [] |
NCT03104699 | 5 | STUDY DRUGS AND TREATMENT | 5. STUDY DRUGS AND TREATMENT | [] |
NCT03104699 | 5.1 | Investigational Medicinal Product | 5.1. Investigational Medicinal Product The investigational medicinal product (IMP), also known as study drug, is AGEN2034, a novel, fully human monoclonal IgG4 antibody designed to block PD-1. AGEN2034 drug product is supplied as a sterile, single-use solution for IV injection in a 2 mL or 10 mL glass vial. AGEN2034 sh... | [] |
NCT03104699 | 5.2 | Packaging and Labeling | 5.2. Packaging and Labeling Study drug packaging and labeling will be in accordance with applicable local regulatory requirements and applicable Good Manufacturing Practice guidelines. The following information will be pre-printed on the vial: vial contents, storage conditions, and lot number. The label will also conta... | [] |
NCT03104699 | 5.3 | Storage and Dispensing | 5.3. Storage and Dispensing The product storage manager should ensure that study drugs are stored in accordance with the environmental conditions (temperature, light, and humidity) as determined in the Pharmacy Manual. If concerns regarding the quality or appearance of the study drug arise, the study drug should not be... | [] |
NCT03104699 | 5.4 | Dosage and Administration | 5.4. Dosage and Administration | [] |
NCT03104699 | 5.4.1 | AGEN2034 | 5.4.1. AGEN2034 AGEN2034 infusions should be administered within 60 minutes (-10/+20 min) using an infusion pump. A central catheter is not required for infusion; however, if a subject has a central venous catheter in place, it is recommended that it be used for the infusion. Once the infusion is completed, all remaini... | [] |
NCT03104699 | 5.4.1.1 | Treatment Regimen | 5.4.1.1. Treatment Regimen In Phase 1, the dose levels and schedules shown in Table 2 will be studied. Table 2: Phase 1 Dosing Regimens | Part and Agent | Dose | Schedule | Duration of Treatment | |-----------------------|--------------|---------------|-----------------------| | Part A1: Dose Level 1 | | | | | AGEN2034... | [] |
NCT03104699 | 5.4.2 | Premedication | 5.4.2. Premedication Premedication should not be administered routinely prior to dosing of drugs. See Section 5.4.3 for subsequent premedication recommendations following AGEN2034-related infusion reactions. | [] |
NCT03104699 | 5.4.3 | Treatment of Infusion Related Reactions | 5.4.3. Treatment of Infusion Related Reactions Acute infusion reactions (which can include cytokine release syndrome, angioedema, or anaphylaxis) are different from allergic/hypersensitive reactions, although some of the manifestations are common to both AEs. Signs and symptoms usually develop during or shortly Confide... | [] |
NCT03104699 | 5.4.4 | Dose Modifications and Treatment Delay | 5.4.4. Dose Modifications and Treatment Delay | [] |
NCT03104699 | 5.4.4.1 | Dose Reductions | 5.4.4.1. Dose Reductions No AGNE2034 dose reduction or escalation is allowed. Each subject will stay on the dose levels assigned in the trial unless treatment needs to be stopped. | [] |
NCT03104699 | 5.4.4.2 | Treatment Delay | 5.4.4.2. Treatment Delay | [] |
NCT03104699 | 5.4.4.2.1 | Criteria for Treatment Delay | 5.4.4.2.1. Criteria for Treatment Delay AGEN2034 administration should be delayed for the following: - Any Grade ≥ 2 non-skin, drug-related AE with the following exceptions: - − Do not delay treatment for Grade ≥ 2 Fatigue and laboratory abnormalities except for: - Delay dosing for Grade ≥ 2 serum creatinine (more than... | [] |
NCT03104699 | 5.4.4.2.2 | Criteria to Resume Treatment | 5.4.4.2.2. Criteria to Resume Treatment Subjects may resume treatment with AGEN2034 when drug-related AE(s) resolve(s) to Grade 1 or baseline value, with the following exceptions: - Subjects may resume treatment in the presence of Grade 2 fatigue. - Subjects who have not experienced a Grade 3 drug-related skin AE may r... | [] |
NCT03104699 | 5.4.5 | Treatment Beyond Disease Progression | 5.4.5. Treatment Beyond Disease Progression Subjects will be permitted, with the Sponsor's approval, to continue with treatment beyond initial RECIST 1.1 defined progressive disease (PD) as long as they meet the following criteria: - Investigator-assessed clinical benefit from the treatment; - Is clinically stable (see... | [] |
NCT03104699 | 5.5 | Concomitant Treatments | 5.5. Concomitant Treatments | [] |
NCT03104699 | 5.5.1 | Acceptable Concomitant Medications | 5.5.1. Acceptable Concomitant Medications All treatments that the investigator considers necessary for a subject's welfare may be administered at the discretion of the investigator in keeping with the community standards of medical care. All concomitant medication will be recorded on the eCRF including all prescription... | [] |
NCT03104699 | 5.5.1.1 | Rescue Medications and Supportive Care | 5.5.1.1. Rescue Medications and Supportive Care Subjects should receive appropriate supportive care measures as deemed necessary by the treating investigator including but not limited to the items outlined below. For guidelines for continuing treatment with AGEN2034, see Section [5.4.4.2.2](#page-51-3). - Diarrhea: Sub... | [] |
NCT03104699 | 5.5.2 | Prohibited and/or Restricted Treatments | 5.5.2. Prohibited and/or Restricted Treatments As stated in the exclusion criteria ([Section](#page-40-0) 4.3), subjects must not have had chemotherapy, radiotherapy (other than palliative bone-directed radiotherapy, as described in [Section](#page-53-1) 5.5.1), major surgery, or received another investigational agent ... | [] |
NCT03104699 | 5.5.3 | Other Restrictions and Precautions | 5.5.3. Other Restrictions and Precautions The following non-drug therapies must not be administered or performed during the study (and within 28 days before the start of trial treatment): - Major surgery (excluding prior diagnostic biopsy). - Herbal remedies with immunostimulating properties (e.g., mistletoe extract) o... | [] |
NCT03104699 | 5.6 | Management of Immune-related Adverse Events | 5.6. Management of Immune-related Adverse Events Immuno-oncology agents such as AGEN2034 are associated with irAEs. Early recognition and management of irAEs may mitigate severe toxicity. Investigators should also monitor subjects closely for potential irAEs, which may manifest at the earliest after weeks of treatment.... | [] |
NCT03104699 | 5.6.1 | Dermatological Immune-related Adverse Events | 5.6.1. Dermatological Immune-related Adverse Events Rule out non-inflammatory causes, if non-inflammatory cause is identified, treat accordingly and continue therapy per protocol. Table 4: Dermatological Immune-related Adverse Event Management Algorithm | | Dermatological Immune-related Adverse Events | | |------------... | [] |
NCT03104699 | 5.6.2 | Gastrointestinal Immune-related Adverse Events | 5.6.2. Gastrointestinal Immune-related Adverse Events Rule out non-inflammatory causes, if non-inflammatory cause is identified, treat accordingly and continue therapy. Opiates/narcotics may mask symptoms of perforation. Infliximab should not be used in cases of perforation or sepsis. Table 5: Gastrointestinal Immune-r... | [] |
NCT03104699 | 5.6.3 | Pulmonary Immune-related Adverse Events | 5.6.3. Pulmonary Immune-related Adverse Events Rule out non-inflammatory causes, if non-inflammatory cause is identified, treat accordingly and continue therapy per protocol. Evaluate with imaging and pulmonary consultation. Table 6: Pulmonary Immune-related Adverse Event Management Algorithm | | Pulmonary Immune-relat... | [] |
NCT03104699 | 5.6.4 | Hepatic Immune-related Adverse Events | 5.6.4. Hepatic Immune-related Adverse Events Rule out non-inflammatory causes, if non-inflammatory cause is identified, treat accordingly and continue therapy per protocol. Consider imaging for obstruction. Table 7: Hepatic Immune-related Adverse Event Management Algorithm | | Hepatic Immune-related Adverse Events | | ... | [] |
NCT03104699 | 5.6.5 | Endocrine Immune-related Adverse Events | 5.6.5. Endocrine Immune-related Adverse Events Rule out non-inflammatory causes, if non-inflammatory cause is identified, treat accordingly and continue therapy per protocol. Consider visual field testing, endocrinology consultation, and imaging. Table 8: Endocrine Immune-related Adverse Event Management Algorithm | | ... | [] |
NCT03104699 | 5.6.6 | Renal Immune-related Adverse Events | 5.6.6. Renal Immune-related Adverse Events Rule out non-inflammatory causes, if non-inflammatory cause is identified, treat accordingly and continue therapy per protocol. Table 9: Renal Immune-related Adverse Event Management Algorithm | | Renal Immune-related Adverse Events | | |---------------------------------------... | [] |
NCT03104699 | 5.6.7 | Neurological Immune-related Adverse Events | 5.6.7. Neurological Immune-related Adverse Events Rule out non-inflammatory causes, if non-inflammatory cause is identified, treat accordingly and continue therapy per protocol. Table 10: Neurological Immune-related Adverse Event Management Algorithm | | Neurological Immune-related Adverse Events | | |-----------------... | [] |
NCT03104699 | 6 | TRIAL ASSESSMENTS AND PROCEDURES | 6. TRIAL ASSESSMENTS AND PROCEDURES | [] |
NCT03104699 | 6.1 | Phase 1 Schedules of Assessments and Procedures | 6.1. Phase 1 Schedules of Assessments and Procedures The assessments and procedures to be performed in Phase 1 are shown in Table 11 for Part A1 and in [Table 12](#page-66-1) for PartA2. Table 11: Phase 1 Part A1 — Schedule of Assessments and Procedures | | Screening | | | | Treatment | Phase | | (2-weekcycles) | | End... | [] |
NCT03104699 | 6.2 | Phase 2 Schedule of Assessments and Procedures | 6.2. Phase 2 Schedule of Assessments and Procedures The assessments and procedures for Phase 2 are summarized in [Table 13](#page-70-0) for PK, ADA, biomarkers, and pharmacogenomics assessments are shown in [Table 14.](#page-73-0) Confidential Page 70 of 113 Table 13: Phase 2 — Schedule of Assessments and Procedures | ... | [] |
NCT03104699 | 6.3 | Visit Requirements | 6.3. Visit Requirements | [] |
NCT03104699 | 6.3.1 | Screening | 6.3.1. Screening Visit requirements are outlined for Phase 1 in [Section](#page-63-1) 6.1 and for Phase 2 in [Section](#page-69-0) 6.2. Specific procedure-related details are provided in [Section](#page-75-2) 6.4. | [] |
NCT03104699 | 6.3.2 | Treatment Phase | 6.3.2. Treatment Phase Visit requirements are outlined for Phase 1 in [Section](#page-63-1) 6.1 and for Phase 2 in [Section](#page-69-0) 6.2. Specific procedure-related details are provided in [Section](#page-75-2) 6.4. Subject should continue to receive all assessments as defined in the Treatment phase of the Schedule... | [] |
NCT03104699 | 6.3.3 | End-of-Treatment Visits | 6.3.3. End-of-Treatment Visits Visit requirements are outlined for Phase 1 in [Section](#page-63-1) 6.1 and for Phase 2 in [Section](#page-69-0) 6.2. Specific procedure-related details are provided in [Section](#page-75-2) 6.4. | [] |
NCT03104699 | 6.3.3.1 | Discontinuation Visit | 6.3.3.1. Discontinuation Visit The Discontinuation Visit should occur at the time study drug is discontinued for any reason. If the Discontinuation Visit occurs 4 weeks from the last dose of study drug, at the time of the mandatory Safety Follow up Visit, procedures do not need to be repeated. Procedures at the time of... | [] |
NCT03104699 | 6.3.3.2 | Safety Follow-up Visit | 6.3.3.2. Safety Follow-up Visit The mandatory Safety Follow-Up Visit should be conducted for all subjects approximately 4 weeks after the last dose of study drug or before the initiation of a new antineoplastic treatment, whichever comes first. Subjects with an AE of Grade >1 will be further followed until the resoluti... | [] |
NCT03104699 | 6.3.4 | Follow-up Phase | 6.3.4. Follow-up Phase In Phase 1, subjects who discontinue treatment will be followed for up to 12 months after the last dose of study drug or until death, withdrawal of consent, or becoming lost to follow-up. In Phase 2, subjects who discontinue treatment will be followed for up to 24 months after the last dose of st... | [] |
NCT03104699 | 6.3.4.1 | Follow-up Visits | 6.3.4.1. Follow-up Visits All subjects who discontinue treatment will have at least one post-treatment visit at 3 months (± 7 days) after last dose of study drug. For both study Phases, subjects who received the maximum administrations of AGEN2034, who have achieved a complete response (CR) according to RECIST 1.1, or ... | [] |
NCT03104699 | 6.3.4.2 | Survival Follow-up (Phase 2 only) | 6.3.4.2. Survival Follow-up (Phase 2 only) There is no survival follow-up for Phase 1. For subjects in Phase 2, after the first Treatment Follow-up Visit, subjects with progressive disease and/or who start new line of therapy will move into Survival Follow-up. Subjects should be contacted by telephone to assess for sur... | [] |
NCT03104699 | 6.4 | Trial Procedures | 6.4. Trial Procedures The schedules of events in [Section](#page-63-1) 6.1 and [Section](#page-69-0) 6.2 summarize the trial procedures to be performed at each visit in Phase 1 and 2, respectively. Individual trial procedures are described in detail below. It may be necessary to perform these procedures at unscheduled ... | [] |
NCT03104699 | 6.4.1 | Administrative Procedures | 6.4.1. Administrative Procedures | [] |
NCT03104699 | 6.4.1.1 | Informed Consent | 6.4.1.1. Informed Consent The investigator or qualified designee must obtain documented consent from each potential subject prior to participating in the clinical trial and for optional pharmacogenomics research. | [] |
NCT03104699 | 6.4.1.2 | General Informed Consent | 6.4.1.2. General Informed Consent Consent must be documented by the subject's dated signature along with the dated signature of the person conducting the consent discussion. A copy of the signed and dated consent form should be given to the subject before participation in the trial. The investigator is responsible for ... | [] |
NCT03104699 | 6.4.1.3 | Consent for Pharmacogenomics Assessment (optional) | 6.4.1.3. Consent for Pharmacogenomics Assessment (optional) Participation in the pharmacogenomics portion of the trial is optional and requires separate informed consent. Participation in the pharmacogenomics portion of the trial will not affect participation in the trial. Subjects may withdraw consent from pharmacogen... | [] |
NCT03104699 | 6.4.1.4 | Review of Inclusion and Exclusion Criteria | 6.4.1.4. Review of Inclusion and Exclusion Criteria All inclusion and exclusion criteria will be reviewed by the investigator or qualified designee to ensure that the subject qualifies for the trial. | [] |
NCT03104699 | 6.4.1.5 | Emergency Medical Support and Subject Card | 6.4.1.5. Emergency Medical Support and Subject Card All subjects will be given an Emergency Medical Support and Subject Card identifying them as participants in a research trial. The card will contain trial site contact information (including direct telephone numbers) to be utilized in the event of an emergency. The in... | [] |
NCT03104699 | 6.4.1.6 | Medical History | 6.4.1.6. Medical History A medical history will be obtained by the investigator or qualified designee. Medical history will include all active conditions; history of hepatitis B virus (HBV), hepatitis C virus (HCV), HIV and/or HPV; and any condition diagnosed within the prior 10 years that are considered to be clinical... | [] |
NCT03104699 | 6.4.1.7 | Review of Baseline Symptoms | 6.4.1.7. Review of Baseline Symptoms Baseline symptoms associated with the disease under study will be assessed for each subject at screening. Baseline symptoms will be Graded and recorded according to NCI CTCAE Version 4.03. Baseline symptoms will be characterized in terms including seriousness, causality to previous ... | [] |
NCT03104699 | 6.4.1.8 | Review of Prior and Concomitant Medications | 6.4.1.8. Review of Prior and Concomitant Medications | [] |
NCT03104699 | 6.4.1.8.1 | Prior Medications | 6.4.1.8.1. Prior Medications All medication — other than chemotherapy — taken by the subject within 30 days before starting the trial will be recorded. In addition, all treatments for a prior cancer other than current cancer will be recorded, even if taken greater than 30 days prior to Visit 1. Prior treatments for the... | [] |
NCT03104699 | 6.4.1.8.2 | Concomitant Medications | 6.4.1.8.2. Concomitant Medications Any medication taken by the subject during the trial, from the date of consent through the 30-day Safety Follow-up Visit, will be recorded. After the Safety Follow-up Visit, record all medications related to reportable SAEs and AESIs as defined in Section [7.2.2.2.](#page-92-0) | [] |
NCT03104699 | 6.4.1.9 | Cancer Disease Details and Prior Treatment | 6.4.1.9. Cancer Disease Details and Prior Treatment Obtain current cancer disease details and prior treatment for all subjects including: - Detailed history of the tumor at diagnosis and study entry including histopathological diagnosis, grading, and staging in accordance with the AJCC-8 Tumor Node Metastasis (TNM) cla... | [] |
NCT03104699 | 6.4.1.9.1 | Subsequent Antineoplastic Therapy | 6.4.1.9.1. Subsequent Antineoplastic Therapy The investigator or qualified designee will review all new antineoplastic therapy initiated after the last dose of study drug. If a subject initiates a new antineoplastic therapy within 4 weeks after the last dose of study drug, the Safety Follow-up Visit must occur before t... | [] |
NCT03104699 | 6.4.1.9.2 | Survival Follow-up (Phase 2 only) | 6.4.1.9.2. Survival Follow-up (Phase 2 only) Once a subject in Phase 2 moves into the survival follow-up period, they should be contacted by telephone every 2 months for up to 12 months after their last dose of study drug. (See also [Section](#page-75-1) 6.3.4.2.) | [] |
NCT03104699 | 6.4.1.10 | Assignment of Subject Trial Number | 6.4.1.10. Assignment of Subject Trial Number After a subject signs an informed consent form, the subject will be assigned a unique, sequential subject number. Once a number is assigned, it cannot be reassigned if the original subject is found to be ineligible or withdraws consent. | [] |
NCT03104699 | 6.4.1.11 | Trial Compliance | 6.4.1.11. Trial Compliance Any delay from the protocol-specified AGEN2034 dosing frequency which is due to toxicity and which results in > 6 weeks between AGEN2034 doses requires consultation between the investigator and the Sponsor, and written documentation of the collaborative decision on subject management. Adminis... | [] |
NCT03104699 | 6.4.2 | Tissue Collection and Tumor Biomarker Assessment | 6.4.2. Tissue Collection and Tumor Biomarker Assessment For Phase 2, expression of PD-L1 and HPV status will be among the exploratory biomarkers assessed in tumor samples from archival tissues or biopsies. | [] |
NCT03104699 | 6.4.2.1 | Tissue Collection | 6.4.2.1. Tissue Collection Tumor tissue for biomarker analysis from a biopsy of a tumor lesion not previously irradiated must be available for biomarker assessments including but not limited to PD-L1 expression and HPV evaluation. Biomarker assessment will be performed on the most recent FFPE biopsy of a tumor lesion, ... | [
"Provision of samples:"
] |
NCT03104699 | 6.4.2.2 | PD-L1 Expression Assessment | 6.4.2.2. PD-L1 Expression Assessment Tumor expression of PD-L1 will be assessed using an FDA-approved test in all subjects in Phase 2. | [] |
NCT03104699 | 6.4.2.3 | HPV Assessment | 6.4.2.3. HPV Assessment For subjects with cervical cancer (Phase 2), tissue sample provided at screening will be used for HPV assessment. Should tissue only be sufficient for PD-L1 expression assessment, the subject may still be enrolled and HPV status will not be assessed. | [] |
NCT03104699 | 6.4.3 | Clinical Assessments and Procedures | 6.4.3. Clinical Assessments and Procedures | [] |
NCT03104699 | 6.4.3.1 | Review of Adverse Events | 6.4.3.1. Review of Adverse Events The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs as specified in the Schedule of Assessments and Procedures and more frequently if clinically indicated. Adverse experiences will be Graded and recorded throughout the study an... | [] |
NCT03104699 | 6.4.3.2 | Physical Examination | 6.4.3.2. Physical Examination | [] |
NCT03104699 | 6.4.3.2.1 | Full Physical Examination | 6.4.3.2.1. Full Physical Examination The investigator or qualified designee will perform a complete physical exam during the screening period, as per [Section](#page-63-1) 6.1 (Phase 1) or [Section](#page-69-0) 6.2 (Phase 2). Clinically significant abnormal findings should be recorded as medical history. After consent,... | [] |
NCT03104699 | 6.4.3.2.2 | Focused Physical Examination | 6.4.3.2.2. Focused Physical Examination For cycles that do not required a full physical exam per [Section](#page-63-1) 6.1 (Phase 1) or [Section](#page-69-0) 6.2 (Phase 2), the investigator or qualified designee will perform a directed physical exam as clinically indicated prior to trial treatment administration. New c... | [] |
NCT03104699 | 6.4.3.3 | Vital Signs, Height and Weight | 6.4.3.3. Vital Signs, Height and Weight Vital signs, height, and weight will be measured and recorded as specified in [Section](#page-63-1) 6.1 (Phase 1, [Table 11](#page-63-2) or [Table 12](#page-66-0)) or [Section](#page-69-0) 6.2 (Phase 2, [Table 13](#page-70-0)). The investigator or qualified designee will take vit... | [] |
NCT03104699 | 6.4.3.4 | 12-lead Electrocardiogram | 6.4.3.4. 12-lead Electrocardiogram A standard 12-lead ECG will be performed using local standard procedures at screening and as specified in [Section](#page-63-1) 6.1 (Phase 1, [Table 11](#page-63-2) or [Table 12](#page-66-0)) or [Section](#page-69-0) 6.2 (Phase 2, [Table 13](#page-70-0)). Clinically significant abnorm... | [] |
NCT03104699 | 6.4.3.5 | Expanded Electrocardiogram Evaluation (in selected sites only) | 6.4.3.5. Expanded Electrocardiogram Evaluation (in selected sites only) In Phase 2, in addition to the standard 12-lead ECGs, expanded ECG evaluation will occur with 12-lead ECG tracings recorded in triplicate at selected sites only and on the following schedule (see also [Table 13](#page-70-0)): - Cycles 1 and 4: - − ... | [] |
NCT03104699 | 6.4.3.6 | Eastern Cooperative Oncology Group Performance | 6.4.3.6. Eastern Cooperative Oncology Group Performance ECOG status will be assessed (see Appendix II) at screening, prior to the administration of each dose of trial treatment and during the Follow-up period as specified in [Section](#page-63-1) 6.1 (Phase 1) or [Section](#page-69-0) 6.2 (Phase 2). | [] |
NCT03104699 | 6.4.4 | Imaging Assessments | 6.4.4. Imaging Assessments | [] |
NCT03104699 | 6.4.4.1 | Tumor Imaging | 6.4.4.1. Tumor Imaging In Phase 1, the initial tumor imaging will be performed within 21 days prior to first dose; however, scans performed as part of routine clinical management are acceptable for use as screening scan if they are of diagnostic quality and performed < 21 days prior to first dose. Onstudy imaging will ... | [] |
NCT03104699 | 6.4.4.2 | Brain Imaging | 6.4.4.2. Brain Imaging MRI is the preferred brain imaging modality; however, CT is acceptable if an MRI is clinically contraindicated. In Phase 1, subjects with no previous history of brain metastases are required to have brain imaging at screening (within 21 days from prior to first treatment dose) unless adequate ima... | [] |
NCT03104699 | 6.4.4.3 | Response Assessment | 6.4.4.3. Response Assessment Response assessment will be done according to RECIST 1.1 ([Eisenhauer et al 2009](#page-106-7)) in Phase 1 and Phase 2. In Phase 1, response will be assessed by an investigator; in Phase 2 response will be assessed by an investigator and by an IERC. For all subjects, tumor response assessme... | [] |
NCT03104699 | 6.4.5 | Pharmacokinetic, Pharmacodynamic, Genetic, and Other Assessments | 6.4.5. Pharmacokinetic, Pharmacodynamic, Genetic, and Other Assessments Sample collection, labeling, storage and shipment instructions will be provided in the operations/laboratory manual. A full chain of custody will be maintained for all samples throughout their lifecycle. Sponsor will keep oversight of the entire li... | [] |
NCT03104699 | 6.4.5.1 | Pharmacokinetic Assessments | 6.4.5.1. Pharmacokinetic Assessments Blood samples will be collected in both study phases for plasma AGEN2034 concentration determinations (for pharmacokinetic evaluation). In Phase 1, PK samples will be collected as shown in [Table 11](#page-63-2) or [Table 12.](#page-66-0) In Phase 2, PK samples will be collected as ... | [] |
NCT03104699 | 6.4.5.2 | Immunogenicity Assessment | 6.4.5.2. Immunogenicity Assessment Blood samples for assessment of the immunogenicity of AGEN2034 will be collected for all subjects at the time points described in [Section](#page-63-1) 6.1 (Phase 1). In Phase 2, ADA samples will be collected as shown in [Table 14](#page-73-0). The immunogenicity assessment will be co... | [] |
NCT03104699 | 6.4.5.3 | Blood Biomarker Assessments | 6.4.5.3. Blood Biomarker Assessments To complete all assessments on blood samples (whole blood and plasma), the Sponsor or designated contract research organization (CRO) will provide instructions and necessary supplies to the site, including shipping materials and prepaid mailers. Refer to the Laboratory Manual for de... | [] |
NCT03104699 | 6.4.5.3.1 | In Phase 1 | 6.4.5.3.1. In Phase 1 | [] |
NCT03104699 | 6.4.5.3.1.1 | RECEPTOR OCCUPANCY | 6.4.5.3.1.1. RECEPTOR OCCUPANCY In Phase 1 only, PD-1 receptor occupancy on circulating T cells will be measured as an indication of target engagement. Confidential Page 85 of 113 | [] |
NCT03104699 | 6.4.5.3.1.2 | IMMUNOPHENOTYPING | 6.4.5.3.1.2. IMMUNOPHENOTYPING Leukocyte subpopulations and immune activation status will be assessed by flow cytometric analysis and/or transcriptional profiling by either RNAseq or other comparable technology using PBMCs. T cell lymphocytes, B lymphocytes, and natural killer cells (TBNK) profiling will be assessed by... | [] |
NCT03104699 | 6.4.5.3.1.3 | CYTOKINE ASSESSMENT | 6.4.5.3.1.3. CYTOKINE ASSESSMENT In Phase 1 only, cytokine profiles will be evaluated at various time points from plasma samples collected according to [Section](#page-63-1) 6.1. | [] |
NCT03104699 | 6.4.5.3.2 | In Phase 2 | 6.4.5.3.2. In Phase 2  Confidential Page 86 of 113  | [] |
NCT03104699 | 6.4.5.4 | Pharmacogenomics Assessments (Optional) | 6.4.5.4. Pharmacogenomics Assessments (Optional) The Sponsor may conduct research on DNA from blood or tumor tissue specimens collected during this trial. This research may include genetic analysis (DNA) and gene expression profiling (RNA). Germline (inherited) variants will be investigated in DNA extracted from the wh... | [] |
NCT03104699 | 6.4.6 | Local Laboratory Tests | 6.4.6. Local Laboratory Tests It is essential that the Sponsor be provided with a list of laboratory normal ranges before shipment of study drug. Any change in laboratory normal ranges during the trial will additionally be forwarded to the CRO and the Sponsor. Blood samples will be collected from non-fasted subjects. A... | [
"Table 15: Required Local Laboratory Panel Tests"
] |
NCT03104699 | 7 | ADVERSE EVENTS | 7. ADVERSE EVENTS | [] |
NCT03104699 | 7.1 | Adverse Event Definitions | 7.1. Adverse Event Definitions | [] |
NCT03104699 | 7.1.1 | Adverse Event | 7.1.1. Adverse Event An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory find... | [] |
NCT03104699 | 7.1.2 | Abnormal Laboratory Findings and Other Abnormal Investigational Findings | 7.1.2. Abnormal Laboratory Findings and Other Abnormal Investigational Findings Abnormal laboratory findings and other abnormal investigational findings (e.g., on an ECG trace) should not be reported as AEs unless they are associated with clinical signs and symptoms, lead to treatment discontinuation, or are considered... | [] |
NCT03104699 | 7.1.3 | Adverse Drug Reaction | 7.1.3. Adverse Drug Reaction An ADR is defined in this trial as any AEs suspected to be related to AGEN2034 by the investigator and/or Sponsor. | [] |
NCT03104699 | 7.1.4 | Serious Adverse Event | 7.1.4. Serious Adverse Event An SAE is any untoward medical occurrence that at any dose: - Results in death. - Is life-threatening. Note: The term "life-threatening" in this definition refers to an event in which the subject is at risk of death at the time of the event; it does not refer to an event that hypothetically... | [] |
NCT03104699 | 7.1.5 | Events That Do Not Meet the Definition of an SAE | 7.1.5. Events That Do Not Meet the Definition of an SAE Elective hospitalizations to administer or to simplify trial treatment or trial procedures (e.g., overnight stay to facilitate chemotherapy and related hydration therapy application) are not Confidential Page 90 of 113 considered SAEs. However, all events leading ... | [] |
NCT03104699 | 7.1.6 | Events not to be Considered as AEs/SAEs | 7.1.6. Events not to be Considered as AEs/SAEs Medical conditions present at the initial trial visit that do not worsen in severity or frequency during the trial are defined as baseline medical conditions, and are not to be considered AEs. | [] |
NCT03104699 | 7.1.7 | AE/SAEs Observed in Association with Disease Progression | 7.1.7. AE/SAEs Observed in Association with Disease Progression Disease progression recorded in the course of efficacy assessments only, but without any adverse signs or symptoms, should not be reported as an AE. However, if adverse signs or symptoms occur in association with disease progression, these should be record... | [] |
NCT03104699 | 7.1.8 | Predefined Potential AEs of Special Interest for Safety Monitoring | 7.1.8. Predefined Potential AEs of Special Interest for Safety Monitoring Selected non-serious and SAEs defined below are considered AESIs and must be recorded as such on the Adverse Event case report forms/worksheets and reported within 24 hours to the Sponsor either by electronic media or paper. Sponsor Contact infor... | [] |
NCT03104699 | 7.2 | Methods of Recording and Assessing Adverse Events | 7.2. Methods of Recording and Assessing Adverse Events At each trial visit, the subject will be queried on changes in his/her condition. During the reporting period of the trial, any unfavorable changes in the subject's condition will be recorded as AEs, whether reported by the subject or observed by the investigator. ... | [] |
NCT03104699 | 7.2.1 | Definition of the Adverse Event Reporting Period | 7.2.1. Definition of the Adverse Event Reporting Period The AE reporting period for safety surveillance begins when the subject provides written consent and continues until either 90 days after the last dose of study drug or the start of new anticancer treatment, whichever comes first. Following the End-of-Treatment Sa... | [] |
NCT03104699 | 7.2.2 | Procedure for Reporting SAEs / AESIs | 7.2.2. Procedure for Reporting SAEs / AESIs All adverse reactions will be reported to the FDA according to 21 Code of Federal Regulations (CFR) 312.32 and according to applicable regulatory authorities and institutional ethics committees. | [] |
NCT03104699 | 7.2.2.1 | Serious Adverse Events | 7.2.2.1. Serious Adverse Events In the event of any new SAE (of any Grade) occurring during the reporting period, the investigator must immediately (i.e., ≤ 24 hours after becoming aware of the event) inform the Sponsor or designee by telephone, fax, or e-mail. For the following significant SAEs the reporting period to... | [] |
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