Phase 2
Completed N=55
Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
Source: ClinicalTrials.gov NCT00553254 ↗Enrolled (actual)
55
Serious AEs
18.2%
Results posted
Oct 2020
Primary outcomePrimary: Recommended Phase 2 Dose (RP2D) - Phase 1 — 45 mg
Summary
To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recommended Phase 2 Dose (RP2D) - Phase 1 |
45 | — |
| PRIMARY Progression-Free Survival (PFS) at Month 4 (PFS4m) - Phase 2 |
47.2 | — |
| SECONDARY Progression-Free Survival (PFS) at Month 6 (PFS6m) - Phase 2 |
24.8 | — |
| SECONDARY Overall Survival (OS) at Month 6 (OS6m) - Phase 2 |
80.7 | — |
| SECONDARY Percentage of Participants With Objective Response - Phase 1 |
0.0; 33.3 | — |
| SECONDARY Soluble Protein Biomarkers Level |
58.57; 57.41; 47.46; 50.81; 46.76; 58.87 | — |
| SECONDARY Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status |
3; 3; 2; 12; 7; 28 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-00299804 30 mg and PF-00299804 45 mg |
13.34; 21.30; 56.96; 82.71 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00299804 30 mg and PF-00299804 45 mg |
8.00; 4.96; 5.03; 6.10 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1 |
63.60; 54.02 | — |
| SECONDARY Area Under the Curve From Time Zero to 24 Hour Post-Dose (AUC0-24) of PF-00299804 30 mg and PF-00299804 45 mg |
221.6; 354.8; 1075; 1621 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00299804 30 mg and PF-00299804 45 mg- Phase 1 |
893.4; 1248 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1 |
1018; 1348 | — |
| SECONDARY Accumulation Ratio (Rac) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1 |
5.265; 5.682 | — |
| SECONDARY Average Plasma Concentration (Cavg) of PF-00299804 30 mg and PF-00299804 45 mg |
44.78; 67.52 | — |
| SECONDARY Linearity Ratio (Rss) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1 |
1.093; 1.442 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Ctrough) of PF-00299804 30 mg and PF-00299804 45 mg |
45.96; 65.11; 46.52; 66.98; 40.34; 69.75 | — |
| SECONDARY Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2 |
5; 18; 16; 2; 20; 17 | — |
| SECONDARY Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2 |
10; 16; 13; 9; 11; 19 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Total Score - Phase 2 |
0.81; 6.54; 9.51; 10.85; 11.04; 10.76 | — |
| SECONDARY Best Overall Response (BOR) - Phase 2 |
0; 7; 21; 13; 0 | — |
| SECONDARY Duration of Response (DR) |
41.9; 60.6 | — |
Eligibility Criteria
Inclusion Criteria
- Advanced NSCLC
- Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib or gefitinib
- Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment
- Measurable disease
Exclusion Criteria
- Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessment
- Patients who lack of tolerance of erlotinib therapy
- Patients with known brain Metastases
- Patients with demonstrated history of or presence of interstitial lung disease.
Data sourced from ClinicalTrials.gov (NCT00553254). 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.