Phase 2
Completed N=66
PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
Source: ClinicalTrials.gov NCT00548093 ↗Enrolled (actual)
66
Serious AEs
22.7%
Results posted
May 2019
Primary outcomePrimary: Best Overall Response (BOR) in Participants With Adenocarcinoma Histology — 0; 2; 28; 12 Participants
Summary
To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response (BOR) in Participants With Adenocarcinoma Histology |
0; 2; 28; 12; 0 | — |
| SECONDARY Best Overall Response (BOR) in Participants With Non-Adenocarcinoma Histology |
0; 1; 8; 7; 0 | — |
| SECONDARY Duration of Response (DR) |
45.2; 12.1 | — |
| SECONDARY Percent Probability of Progression-free Survival (PFS) at Month 6 |
24.3; 8.0 | — |
| SECONDARY Percent Probability of Overall Survival at Months 6 and 12 |
71.5; 50.0; 46.3; 21.9 | — |
| SECONDARY Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] |
390.8; 397.9 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
22.61; 25.49 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
6.08; 6.17 | — |
| SECONDARY Human Epidermal Growth Factor-2 (HER-2) and Epidermal Growth Factor Receptor (EGFR) Levels in Serum |
51.25; 57.28; 45.89; 51.05; 44.91; 46.79 | — |
| SECONDARY Number of Participants With Human Epidermal Growth Factor Family (HER-Family) and Kirsten Rat Sarcoma (KRAS) Gene Mutation Status From Free Tumor Deoxy- Ribonucleic Acid (DNA) in Blood at Screening |
39; 15; 0; 0; 11; 1 | — |
| SECONDARY European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score |
65.83; 60.56; 74.70; 70.22; 72.67; 74.44 | — |
| SECONDARY European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score |
25.85; 26.98; 33.33; 33.33; 2.00; 4.44 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Score |
0.38; 0.80; 3.34; 2.08; 4.08; 3.08 | — |
| SECONDARY Percentage of Participants With Progression-free Survival (PFS) |
24.3; 8.0 | — |
Eligibility Criteria
Inclusion Criteria
- Advanced Non-Small Cell Lung Cancer (NSCLC)
- Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
- Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
- Measurable disease .
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Tissue available for KRAS/ EGFR testing
- Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN
Exclusion Criteria
- Chemotherapy
- Radiotherapy
- Biological or investigational agents within 4 weeks of baseline disease assessment.
- Patients who lack of tolerance of erlotinib therapy.
Data sourced from ClinicalTrials.gov (NCT00548093). 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.