Trial · NCT00965731
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) | Baseline up to Day 28 | DLT evaluable population: all participants in dose escalation phase receiving at least 1 dose of study medication who did not have a major treatment deviation during the first cycle (for example, less than 80% of planned dose of PF-02341066 or erlotinib in cycle 1 for reasons other than treatment-related toxicities) | participants | NUMBER |
| PRIMARY | Progression-Free Survival (Phase 2) | Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity | Not analyzed due to phase 2 study termination | ||
| SECONDARY | PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1) | C1D15 i.e., 15 days of giving crizotinib and erlotinib | The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest. | L/hr | GEOMETRIC_MEAN |
| SECONDARY | PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1) | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Erlotinib Apparent Oral Clearance (CL/F) (Phase 1) | C1D15 i.e., 15 days of giving crizotinib and erlotinib | The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest. | L/hr | GEOMETRIC_MEAN |
| SECONDARY | Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1) | C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib) | The PK parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest. | Ratio in percentage | GEOMETRIC_MEAN |
| SECONDARY | Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1) | C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib) | The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest. | Ratio in percentage | GEOMETRIC_MEAN |
| SECONDARY | Progression-Free Survival (Phase 1) | Baseline, every 42 days until disease progression or unacceptable toxicity | not analyzed due to small number of study participants | ||
| SECONDARY | Duration of Response (Phase 1) | Baseline, every 42 days until disease progression or unacceptable toxicity | not analyzed due to small number of responses | ||
| SECONDARY | Percentage of Participants With Objective Response (Phase 1) | Baseline, every 42 days until disease progression or unacceptable toxicity | Response Evaluable Population: all participants enrolled into the Phase 1 portion of the study who receive at least one dose of study medication (either PF-02341066 or erlotinib) and have an adequate baseline tumor assessment. | percentage of participants | NUMBER |
| SECONDARY | Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1) | Baseline and Day 50 (Cycle 3, Day 1) | The soluble biomarker evaluable population was defined as participants from the safety analysis set of phase 1 who had a soluble protein blood sample taken prior to dosing on Cycle 3 Day 1 and 1 soluble biomarker evaluation after dosing on Cycle 3 Day 1. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1) | Baseline and Day 50 (Cycle 3, Day 1) | Plasma level of soluble marker HGF scatter factor not analyzed due to prior experience with high levels of intra participant variability | ||
| SECONDARY | Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2) | Baseline and Day 50 (Cycle 3, Day 1) | Not analyzed due to phase 2 study termination | ||
| SECONDARY | Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2) | Baseline and Day 50 (Cycle 3, Day 1) | Not analyzed due to phase 2 study termination |
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.
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