Phase 1
Completed N=27
Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
Source: ClinicalTrials.gov NCT00965731 ↗Enrolled (actual)
27
Serious AEs
37.0%
Results posted
Jan 2013
Primary outcomePrimary: Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) — 2; 3 participants
Summary
This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) |
2; 3 | — |
| PRIMARY Progression-Free Survival (Phase 2) |
— | — |
| SECONDARY PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) |
581.9; 400.3; 2274; 1720 | — |
| SECONDARY PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) |
86.75; 65.31; 251.0; 185.9 | — |
| SECONDARY PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1) |
88.02; 87.20 | — |
| SECONDARY PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) |
16.48; 14.03; 60.36; 57.77 | — |
| SECONDARY PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1) |
2.625; 2.087; 7.093; 6.508 | — |
| SECONDARY Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1) |
0.02748; 0.03395; 0.02574; 0.03258 | — |
| SECONDARY Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) |
23490; 26880; 26520; 30040; 41770; 38910 | — |
| SECONDARY Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1) |
1593; 1797; 1452; 1723; 2546; 2346 | — |
| SECONDARY Erlotinib Apparent Oral Clearance (CL/F) (Phase 1) |
2.395; 2.572 | — |
| SECONDARY Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1) |
184.80; 149.41 | — |
| SECONDARY Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1) |
160.15; 134.60 | — |
| SECONDARY Progression-Free Survival (Phase 1) |
— | — |
| SECONDARY Duration of Response (Phase 1) |
— | — |
| SECONDARY Percentage of Participants With Objective Response (Phase 1) |
14.3; 5.6 | — |
| SECONDARY Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1) |
1560.0; 1454.6; 1870.0; 1525.9; 1660.0; 1600.0 | — |
| SECONDARY Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1) |
— | — |
| SECONDARY Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2) |
— | — |
| SECONDARY Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2) |
— | — |
| SECONDARY Duration of Response (Phase 2) |
— | — |
| SECONDARY Percentage of Participants With Confirmed CR, PR or Stable Disease (SD) at Phase 2 |
— | — |
| SECONDARY Percentage of Participants With Objective Response (Phase 2) |
— | — |
| SECONDARY Overall Survival (OS) at Phase 2 |
— | — |
| SECONDARY European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ-C30) Score at Phase 2 |
— | — |
| SECONDARY EORTC Quality of Life Questionnaire -Lung Cancer 13 (QLQ-LC13) Score at Phase 2 |
— | — |
| SECONDARY Plasma Concentration of PF-02341066 and Erlotinib (Phase 2) |
— | — |
| SECONDARY Plasma Concentration of Erlotinib (Phase 2) |
— | — |
| SECONDARY Percentage of Participants With Mutations in Tumor Tissue (Phase 2) |
— | — |
Eligibility Criteria
Inclusion Criteria
- histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)
- evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease
- tumors must have measurable disease as per RECIST
Exclusion Criteria
- known interstitial lung disease
- prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)
Data sourced from ClinicalTrials.gov (NCT00965731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.