Carcinoma, Non-small Cell Clinical Trial
Official title:
A PHASE 2, OPEN-LABEL TRIAL OF DACOMITINIB (PF-00299804) IN SELECTED PATIENTS WITH ADVANCED ADENOCARCINOMA OF THE LUNG
| Verified date | December 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.
| Status | Completed |
| Enrollment | 119 |
| Est. completion date | April 30, 2015 |
| Est. primary completion date | April 27, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Advanced adenocarcinoma of lung, measurable disease - Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR - patients with known EGFR activating mutation regardless of smoking status - ECOG(Eastern Cooperative Oncology Group) 0-1. Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy Exclusion Criteria: - Active brain metastases - Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy. - known EGFR wild type NSCLC |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Department of Clinical Oncology, Tuen Mun Hospital | New Territories | |
| Hong Kong | Prince of Wales Hospital | Shatin, NT | |
| Hong Kong | Department of Clinical Oncology, Tuen Mun Hospital | Tuen Mun | NEW Territories |
| Hong Kong | Department of Clinical Oncology, Tuen Mun Hospital | Tuen Mun | NEW Territories |
| Japan | Aichi cancer center central hospital Thoracic Oncology | Aichi | |
| Japan | The Cancer Institute Hospital of JFCR | Koto-Ku | Tokyo |
| Korea, Republic of | SamsungMedicalCenter, Sungkyunkwan Univ School of Medicine | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center | Seoul | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| United States | University of Colorado Clinical Trials Office (CTO) | Aurora | Colorado |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | National Institutes of Health National Cancer Institute | Bethesda | Maryland |
| United States | Legacy Pharma Research | Bismarck | North Dakota |
| United States | Mid Dakota Clinic, P.C | Bismarck | North Dakota |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Brigham & Women's Hospital | Boston | Massachusetts |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | Dana-Farber Cancer lnstitute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Division of Hemotology/Oncology | Chapel Hill | North Carolina |
| United States | Investigational Drug Service, Pharmacy Department, UNC Hospitals | Chapel Hill | North Carolina |
| United States | UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Chattanooga Oncology & Hematology Associates, P.C. | Chattanooga | Tennessee |
| United States | Morris Cancer Center | Durham | North Carolina |
| United States | Florida Cancer Specialists | Fort Myers | Florida |
| United States | Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | Chao Family Comprehensive Cancer Center UC Irvine Medical Center | Orange | California |
| United States | University of California, Irvine | Orange | California |
| United States | Bay Area Cancer Research Group, LLC | Pleasant Hill | California |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | Pacific Cancer Care | Salinas | California |
| United States | San Francisco General Hospital | San Francisco | California |
| United States | Seattle Cancer Care Alliance | Seattle | Washington |
| United States | University of Washington Medical Center | Seattle | Washington |
| United States | St. John's Hospital, | Springfield | Missouri |
| United States | Stony Brook University Medical Center - Cancer Center | Stony Brook | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Hong Kong, Japan, Korea, Republic of, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) at Month 4: Cohort A | PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease [PD] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions. | Baseline up to Month 4 | |
| Secondary | Progression-Free Survival (PFS) at Month 4: Cohort B | PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as PD or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on RECIST v1.0 criteria. PD: >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions. | Baseline up to Month 4 | |
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44. PD: >= 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions. Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria. | Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. | |
| Secondary | Best Overall Response (BOR) | BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0. Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions. PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response. SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks. | Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. | |
| Secondary | Duration of Response (DR) | Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for a subgroup of participants with a confirmed objective tumor response. | Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle. | |
| Secondary | Overall Survival (OS) | Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Randomization until death or last date known to be alive. | |
| Secondary | European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms. Improvement was defined as a mean increase from baseline of =10 for GHS and functional scales or a mean decrease from baseline of =10 for symptom scales. Worsened was defined as a mean decrease from baseline of =10 for GHS and functional scales or a mean increase from baseline of =10 for symptom scales. Stable was a mean change from baseline of <10. | Baseline (Cycle [C]1 Day 1), up to C75 | |
| Secondary | European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ). Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain. Improvement was defined as a mean decrease from baseline of =10. Worsened was defined as a mean increase from baseline of =10. Stable was a mean change from baseline of <10. | Baseline (C1D1) up to C75 | |
| Secondary | Trough Plasma Concentrations (Ctrough) of Dacomitinib | Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment). | Predose on C1D14, C2D1, C3D1, C4D1 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00728390 -
A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks
|
Phase 1 |