Clinical trial NCT00553254: Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer
Official title: A PHASE 1/2, OPEN-LABEL, SINGLE ARM TRIAL TO DETERMINE THE RECOMMENDED PHASE 2 DOSE AND EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS IN KOREA WITH KRAS WILD TYPE ADVANCED NSCLC, WHICH IS REFRACTORY TO CHEMOTHERAPY AND ERLOTINIB OR GEFITINIB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non Small Cell Lung
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.


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.

Primary outcomes:
measure: Recommended Phase 2 Dose (RP2D) - Phase 1
timeFrame: Baseline up to Day 21
measure: Progression-Free Survival (PFS) at Month 4 (PFS4m) - Phase 2
timeFrame: Month 4
Secondary outcomes:
measure: Progression-Free Survival (PFS) at Month 6 (PFS6m) - Phase 2
timeFrame: Month 6
measure: Overall Survival (OS) at Month 6 (OS6m) - Phase 2
timeFrame: Month 6
measure: Percentage of Participants With Objective Response - Phase 1
timeFrame: Baseline until disease progression or initiation of new anti-cancer therapy or death, assessed every 2 (odd-numbered) cycles up to 12 months after end of treatment (EOT) (EOT: up to Day 506)
measure: Soluble Protein Biomarkers Level
timeFrame: Cycle 1 Day 1 (C1D1, Baseline), Day 1 of each odd-numbered cycle up to Cycle 17 for both Phase 1 and Phase 2
measure: Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status
timeFrame: Screening
measure: Maximum Observed Plasma Concentration (Cmax) of PF-00299804 30 mg and PF-00299804 45 mg
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9 for Phase 1, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00299804 30 mg and PF-00299804 45 mg
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on Cycle 0 Day -9 (C0D-9) for Phase 1, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2
measure: Plasma Decay Half-Life (t1/2) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on Cycle 0 Day -9 (C0D-9)
measure: Area Under the Curve From Time Zero to 24 Hour Post-Dose (AUC0-24) of PF-00299804 30 mg and PF-00299804 45 mg
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on Cycle 0 Day -9 (C0D-9) for Phase 1, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00299804 30 mg and PF-00299804 45 mg- Phase 1
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9
measure: Accumulation Ratio (Rac) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C0D-9, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14
measure: Average Plasma Concentration (Cavg) of PF-00299804 30 mg and PF-00299804 45 mg
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14 for Phase 1 and 2
measure: Linearity Ratio (Rss) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 24, 72, 144, 216 hours post-dose on C0D-9, 0 (pre-dose), 2, 4, 6, 8, 24 hours post-dose on C1D14
measure: Minimum Observed Plasma Trough Concentration (Ctrough) of PF-00299804 30 mg and PF-00299804 45 mg
timeFrame: 0 hours (pre-dose) on C2D1, C3D1, C4D1
measure: 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
timeFrame: Baseline up to end of treatment (up to Day 889)
measure: 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
timeFrame: Baseline up to end of treatment (up to Day 889)
measure: Dermatology Life Quality Index (DLQI) Total Score - Phase 2
timeFrame: C1D1 (baseline), D1 of each subsequent cycle up to C44
measure: Best Overall Response (BOR) - Phase 2
timeFrame: Baseline until disease progression or initiation of new anti-cancer therapy or death, assessed every 2 (odd-numbered) cycles up to 12 months after EOT (EOT: up to Day 1723)
measure: Duration of Response (DR)
timeFrame: Baseline until disease progression or initiation of new anti-cancer therapy or death, assessed every 2 (odd-numbered) cycles up to 12 months after EOT (EOT: up to Day 506 for Phase 1 and up to Day 1723 for Phase 2)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Department of Medicine
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Park K, Cho BC, Kim DW, Ahn MJ, Lee SY, Gernhardt D, Taylor I, Campbell AK, Zhang H, Giri N, Letrent SP, O'Connell J, Heo DS. Safety and efficacy of dacomitinib in korean patients with KRAS wild-type advanced non-small-cell lung cancer refractory to chemotherapy and erlotinib or gefitinib: a phase I/II trial. J Thorac Oncol. 2014 Oct;9(10):1523-31. doi: 10.1097/JTO.0000000000000275.