Trial · NCT03267940
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Run-in Portion: Number of Participants With Adverse Events (AEs) | From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days) | Safety population included all participants who received any study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry) | From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days) | Safety population included all participants who received any study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs | From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| PRIMARY | Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication | From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days) | Safety population included all participants who received any study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response | From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 421 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response | From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 508 days) | Data for this outcome measure was not Collected due to early termination of study. | ||
| SECONDARY | Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1 | From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1 | From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD) | From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Expansion Portion: Overall Survival (OS) | From randomization until death from any cause (maximum exposure: 421 days) | This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module. | ||
| SECONDARY | Expansion Portion: OS by PD-L1 Expression Levels | From randomization until death from any cause (maximum exposure: 421 days) | This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module. | ||
| SECONDARY | Expansion Portion: Number of Participants With AEs | From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days) | Safety population included all participants who received any study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Expansion Portion: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters (Hematology and Blood Chemistry) | From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days) | Safety population included all participants who received any study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Expansion Portion: Number of Participants With Clinically Significant Abnormalities in ECG and Vital Signs | From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Expansion Period: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication | From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 421 days) | Safety population included all participants who received any study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Run-in and Expansion Portion : Maximum Observed Plasma Concentration (Cmax) of PEGPH20, ATEZO, GEM, and CIS | PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and end of treatment (EOT) (maximum exposure: 508 days for run-in and 421 days for expansion); CIS and GEM: Cycle 1: multiple timepoints on Days 2,9 | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Run-in and Expansion Portion : Minimum Observed Plasma Concentration (Cmin) of PEGPH20 and ATEZO | PEGPH20 and ATEZO: Treatment Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15; ATEZO: Day 1 of subsequent cycles and EOT visit (7 days after last 21-day cycle) (maximum exposure: 508 days for run-in portion and 421 days for expansion portion) | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Run-in and Expansion Portion : Elimination Rate Constant (Kel) of PEGPH20 | Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15 | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Run-in and Expansion Portion : Terminal Elimination Plasma Half-life (t1/2) of PEGPH20, ATEZO, GEM, and CIS | PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9 | Data for this outcome measure was not collected due to early termination of study. | ||
| SECONDARY | Run-in and Expansion Portion : Clearance (CL) of PEGPH20, ATEZO, GEM, and CIS | PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9 | Data for this outcome measure was not collected due to early termination of study. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03267940/outcomes