Trial · NCT01999972
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | Cycle 1 (28 days) | Per protocol analysis set:all enrolled participants who received at least 1 dose of study drug, experienced either DLT during first cycle,or completed first cycle observation period.Participants who lost to follow up before receiving at least 75% of planned first cycle dose due to reasons other than treatment-related AEs were not evaluable for DLT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 or Higher Adverse Events (AEs) as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03 | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the number analyzed field signifies that none of the participant were evaluable at specified time point. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the number analyzed field signifies that none of the participant were evaluable at specified time point. | beats per minute (bpm) | MEAN |
| SECONDARY | Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the number analyzed field signifies that none of the participant were evaluable at specified time point. | kilograms | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value | Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Maximum Increase From Baseline in QTc Interval | Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Axitinib and Crizotinib | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 | Pharmacokinetic (PK) parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. | nanogram per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib and Crizotinib | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 | The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. | hours | MEDIAN |
| SECONDARY | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Axitinib and Crizotinib | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 | The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. | nanogram*hour per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Apparent Oral Clearance (CL/F) of Axitinib and Crizotinib | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 | The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. | liters per hour | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution (Vz/F) of Axitinib and Crizotinib | Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15 | Data for this outcome measure was not collected due to change in planned analysis. | ||
| SECONDARY | Percentage of Participants With Objective Response | From Baseline until disease progression or death, whichever occurred first (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Response-evaluable analysis set included all participants who received at least 1 dose of axitinib and crizotinib and had an adequate baseline tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Dose Expansion Part: Duration of Response | From first objective response until first recurrent, disease progression, or death, whichever occurred first (up to 35 cycles, each cycle 28 days) | Subset of response evaluable analysis set included all participants with overall objective response of CR or PR who received at least 1 dose of axitinib and crizotinib and had baseline tumor assessment. Data for this outcome measure was not planned to be collected and analyzed for dose escalation part, as pre specified in protocol. | months | MEDIAN |
| SECONDARY | Dose Expansion Part: Progression-Free Survival (PFS) | From Baseline until disease progression or death, whichever occurred first (up to 35 cycles, each cycle 28 days) | Response-evaluable analysis set included all participants who received at least 1 dose of axitinib and crizotinib and had an adequate baseline tumor assessment. Data for this outcome measure was not planned to be collected and analyzed for dose escalation part, as pre specified in protocol. | months | MEDIAN |
| SECONDARY | Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers | Baseline, Cycle 2 Day 1, end of treatment (up to 35 cycles, each cycle 28 days) | Serum soluble protein biomarker analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement. | nanograms per milliliter (ng/mL) | MEAN |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01999972/outcomes