A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
NCT01970865
ABOUT THIS STUDY
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- Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, AJCC v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA) approved FISH assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc), or a ROS1 rearrangement as determined by FISH or RT PCR or Next Generation Sequencing (NGS) via a local diagnostic test (LDT). All patients (ALK positive and ROS1 positive) must have archival tissue sample available and collected prior to enrollment.
- Disease Status Requirements:
Phase 1: ALK-positive NSCLC and ROS1-positive patients must either be treatment naïve in the advanced setting or have had disease progression after at least 1 previous ALK/ROS1 inhibitor therapy(ies).
Phase 2:
ALK-positive NSCLC patients must either be or have had:
- Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ALK inhibitor therapy allowed).
- Disease progression after crizotinib only. No prior chemotherapy is allowed in the metastatic disease setting.
- Disease progression after crizotinib and 1 or 2 prior regimens of chemotherapy in the metastatic disease setting.
- Disease progression after 1 prior ALK inhibitor therapy other than crizotinib. Patients may have had any number of prior chemotherapy regimens in any disease setting.
- Disease progression after 2 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting.
- Disease progression after 3 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting.
ROS1-positive NSCLC patients may be:
- Treatment naïve (ie, no prior chemotherapy in the metastatic disease setting and no prior ROS inhibitor therapy).
- Any number of prior therapies (ie, chemotherapy and/or ROS inhibitor therapies).
- Tumor Requirements:
All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) will be eligible. Patients who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) are eligible.
- Adequate Bone Marrow, Pancreatic Function, Renal Function and Liver Function.
- Negative Serum pregnancy test for females of childbearing potential
- Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study
entry. Whole brain radiation must have completed at least 4 weeks prior to study
entry.
- Systemic anti cancer therapy completed within a minimum of 5 half lives of study
entry.
- Prior therapy with an antibody or drug specifically targeting T-cell co-stimulation or
immune checkpoint pathways, including, but not limited to, anti-PD-1, anti-PD-L1,
anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4
(anti-CTLA-4) antibody.
- Active and clinically significant bacterial, fungal, or viral infection including
hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or
acquired immunodeficiency syndrome (AIDS) related illness.
- Clinically significant cardiovascular disease (that is, active or <3 months prior to
enrollment): cerebral vascular accident/stroke, myocardial infarction, unstable
angina, congestive heart failure (New York Heart Association Classification Class ≥
II), second-degree or third-degree AV block (unless paced) or any AV block with PR
>220 msec. Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial
fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is otherwise
healthy such as long-distance runners, etc.), machine-read ECG with QTc >470 msec, or
congenital long QT syndrome.
- History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial
fibrosis or interstitial lung disease including a history of pneumonitis,
hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease,
obliterative bronchiolitis and pulmonary fibrosis.
- Current use or anticipated need for food or drugs that are known strong or moderate
CYP3A4 inhibitors, inducers and substrates; drugs that are CYP2C9 substrates; drugs
that are sensitive CYP2B6 substrates; drugs that are strong CYP2C19 inhibitors; drugs
that are strong CYP2C8 inhibitors; and drugs that are P-gp substrates.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations | ||||||
Official Title ICMJE | PHASE 1/2 STUDY OF PF-06463922 (AN ALK/ROS1 TYROSINE KINASE INHIBITOR) IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS | ||||||
Brief Summary | Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung cancer patients . | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE | 334 | ||||||
Original Estimated Enrollment ICMJE | 200 | ||||||
Estimated Study Completion Date ICMJE | August 19, 2022 | ||||||
Actual Primary Completion Date | March 15, 2017 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Phase 1: ALK-positive NSCLC and ROS1-positive patients must either be treatment naïve in the advanced setting or have had disease progression after at least 1 previous ALK/ROS1 inhibitor therapy(ies). Phase 2: ALK-positive NSCLC patients must either be or have had:
ROS1-positive NSCLC patients may be:
All Patients must have at least one measurable target extracranial lesion according to RECIST v1.1. In addition patients with asymptomatic CNS metastases (including patients asymptomatic by means of stable or decreasing doses of steroids within the last 2 weeks prior to study entry) will be eligible. Patients who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) are eligible.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Singapore, Spain, Switzerland, Taiwan, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01970865 | ||||||
Other Study ID Numbers ICMJE | B7461001 2013-002620-17 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | July 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |