Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer

NCT00553254 | Completed Phase 2 Results

• 1 other identifier: A7471003
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Carcinoma, Non Small Cell Lung

Outcome Measures

Primary Outcomes (2)

• Recommended Phase 2 Dose (RP2D) - Phase 1

  The highest dose at which less than (\<) 33 percent (%) of participants experienced dose-limiting toxicities (DLT) was to be designated as the maximum tolerated dose (MTD) as well as the RP2D. DLT was defined as any of the following events: Grade 3/4 (severe or life-threatening/ disabling adverse event \[AE\]) nausea, vomiting, or diarrhea (despite the use of adequate/maximal medical intervention and/or prophylaxis); Grade greater than or equal to (\>=) 3 (severe or life-threatening/disabling AE or death related to AE) non-hematological toxicity; delayed (which delayed scheduled treatment for \>14 days) recovery from toxicity related to treatment with PF-00299804; Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells per cubic millimeter \[cells/mm\^3\] for 5 or more consecutive days or febrile neutropenia \[fever \>=38.5 degrees Celsius with ANC \<1000 cells/mm\^3\]); and Grade 4 thrombocytopenia (\<25,000 cells/mm\^3) or bleeding which required platelet transfusion.

  Baseline up to Day 21

• Progression-Free Survival (PFS) at Month 4 (PFS4m) - Phase 2

  PFS4m was defined as percent chance of being event free (event defined as progressive disease \[PD\] or death due to any cause, whichever occurred first) at 4 months. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

  Month 4

Secondary Outcomes (20)

• Progression-Free Survival (PFS) at Month 6 (PFS6m) - Phase 2

  Month 6

• Overall Survival (OS) at Month 6 (OS6m) - Phase 2

  Month 6

• Percentage of Participants With Objective Response - Phase 1

  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)

• Soluble Protein Biomarkers Level

  Cycle 1 Day 1 (C1D1, Baseline), Day 1 of each odd-numbered cycle up to Cycle 17 for both Phase 1 and Phase 2

• Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status

  Screening

Study Arms (1)

1

EXPERIMENTAL

Drug: PF-00299804

Interventions

PF-00299804 DRUG

Single arm (no comparator) study, oral once daily dosing, dose escalation (it is a phase 1/2 study) until disease progression, unacceptable toxicity or withdrawal of consent

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Seoul National University Hospital, Department of Internal Medicine

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center

Seoul, 120-752, South Korea

Location

Samsung Medical Center, Department of Medicine

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25521398 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: February 5, 2008
• Primary Completion: August 3, 2010
• Study Completion: July 17, 2014
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

KR (3)