Lung Cancer Clinical Trial

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

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 .

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

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 Exclusion Criteria
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 accidentstroke, myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), second-degree or third-degree AV block (unless paced) any 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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

334

Study ID:

NCT01970865

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 62 Locations for this study

See Locations Near You

Highlands Oncology Group/Research
Fayetteville Arkansas, 72703, United States
Highlands Oncology Group
Rogers Arkansas, 72758, United States
Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
UC Irvine Medical Center
Orange California, 92868, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
MDZ: Yale-New Haven Hospital
New Haven Connecticut, 06504, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven Connecticut, 06510, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Karmanos Center Institute
Detroit Michigan, 48201, United States
Karmanos Cancer Institute
Farmington Hills Michigan, 48334, United States
Siteman Cancer Center-West County
Creve Coeur Missouri, 63141, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University Infusion Center Pharmacy
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Siteman Cancer Center-South County
Saint Louis Missouri, 63129, United States
Rockefeller Patient Pavilion - Memorial Sloan Kettering
New York New York, 10022, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Rochester Regional Health System
Rochester New York, 14621, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
The Ohio State University
Columbus Ohio, 43205, United States
The Ohio State University
Columbus Ohio, 43210, United States
The Ohio State University
Columbus Ohio, 43221, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Sarah Cannon Research Institute (Pharmacy)
Nashville Tennessee, 37203, United States
Chris O'Brien Lifehouse
Sydney Local Health District [rpa] New South Wales, 2050, Australia
Chris O'Brien Lifehouse
Sydney New South Wales, 2050, Australia
Royal Prince Alfred Hospital
Sydney New South Wales, 2050, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
University Hospital Antwerp
Edegem , 2650, Belgium
British Columbia Cancer Agency-Vancouver Centre
Vancouver British Columbia, V5Z 4, Canada
The Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
CHU Grenoble/ Hôpital Albert Michallon
Grenoble Cedex 9 , 38043, France
CHU de Rennes - Hôpital Pontchaillou - CIC Inserm
Rennes Cedex 9 , 35033, France
CHU de Rennes - Hôpital Pontchaillou
Rennes Cedex 9 , 35033, France
Institut Universitaire du Cancer de Toulouse (IUCT-O)
Toulouse Cedex 9 , 31059, France
Institut Gustave Roussy (comite poumon-pneumologie)
Villejuif Cedex , 94805, France
Institut Gustave Roussy- Pharmacie-Unite Essais Cliniques
Villejuif , 94805, France
Universitaetsklinik Koeln
Cologne , 50937, Germany
Department of Clinical Oncology, Prince of Wales Hospital
Shatin , , Hong Kong
Struttura Operativa Complessa Oncologia
Aviano (PN) , 33081, Italy
Dipartimento di Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative
Milano , 20132, Italy
Unita di Farmacologia Clinica e Nuovi Farmaci
Milano , 20141, Italy
Oncologia Medica
Perugia , 06132, Italy
Aichi Cancer Center Hospital
Nagoya Aichi, 464-8, Japan
Nagoya University Hospital
Nagoya Aichi, 466-8, Japan
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama Ehime, 791-0, Japan
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan
Hyogo Cancer Center
Akashi Hyogo, 673-8, Japan
Kindai University Hospital
Osakasayama Osaka, 589-8, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka, 411-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo , 135-8, Japan
Seoul National University Hospital / Department of Internal Medicine
Seoul , 03080, Korea, Republic of
National University Hospital
Singapore , 11907, Singapore
National University Hospital Medical Centre
Singapore , 11908, Singapore
National Cancer Center
Singapore , 16961, Singapore
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón Madrid, 28223, Spain
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Hospital Universitario Quiron Dexeus
Barcelona , 08028, Spain
Hospital Universitari de la Vall D'Hebron Edificio General. Planta Baja. UITM. Servicio de Oncologia
Barcelona , 08035, Spain
Hospital of Lausanne (CHUV)
Lausanne , 1011, Switzerland
Kantonsspital Winterthur
Winterthur , 8401, Switzerland
National Taiwan University Hospital
Taipei , 100, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

334

Study ID:

NCT01970865

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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