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A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer

Information source: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Cancer

Intervention: IPI 504 plus Docetaxel (Drug); Placebo plus Docetaxel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Infinity Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Tess Schmalbach, MD, Study Director, Affiliation: Infinity Pharmaceuticals, Inc.

Summary

The purpose of this study is to compare the impact of IPI-504 in combination with docetaxel to placebo in combination with docetaxel on life expectancy in patients with Non Small Cell Lung cancer (NSCLC). Docetaxel is an approved chemotherapy for NSCLC. An additional goal of the study is to determine the effect of IPI-504, in combination with docetaxel, verses placebo in, combination with docetaxel, on the growth of cancer

Clinical Details

Official title: A Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall Survival

Secondary outcome:

Progression Free Survival

Overall Response Rate

Time to Progression

Detailed description: This is a Phase 2, double-blind, randomized, placebo-controlled study in patients with previously treated, locally advanced or metastatic Stage IIIb or IV NSCLC designed to compare IPI-504 plus docetaxel versus placebo plus docetaxel. All patients will have at least a 15 pack year smoking history. Tumor samples will be assessed by a central pathology reviewer to confirm pathology that is documented at baseline; this review need not occur in advance of randomization.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must be ≥18 years of age

- Voluntarily signed an informed consent

- Confirmed NSCLC and Stage IIIB or IV disease.

- At least a ≥15 pack year smoking history and must have been an active smoker within

20 years of diagnosis.

- Must have archival NSCLC tissue available to provide for analysis or have a lesion

that is accessible for biopsy

- Must have experienced disease progression during or after receiving at least 1 prior

platinum-containing chemotherapy regimen.

- Must have received no more than 2 prior chemotherapy regimens

- Measurable disease by RECIST 1. 1 criteria.

- ECOG performance status of 0 or 1 (Refer to scale in Appendix 1).

- Women of child-bearing potential (WCBP), all sexually active male patients, and

partners of patients must agree to use adequate methods of birth control. Exclusion Criteria:

- Prior docetaxel, IPI-504 or other Hsp90 inhibitor treatment

- Known hypersensitivity to drugs formulated with polysorbate-80.

- Not recovered from any toxicities related to prior treatment

- Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer

- Inadequate hematologic function

- Inadequate hepatic function

- Inadequate renal function

- Symptomatic keratitis or keratoconjunctivitis.

- Uncontrolled systemic fungal, bacterial, viral or other infection

- Patients with clinically active brain metastases

- Patients with clinically stable brain metastases (previously treated or untreated)

are eligible.

- Sinus bradycardia (resting heart rate <50 bpm).

- Significant cardiac disease

- Previous or current malignancies at other sites within the last 2 years

- Prior hepatic resections or hepatic-directed therapy

- Known HIV-positive patients receiving combination antiretroviral therapy.

- Women who are pregnant or lactating.

Locations and Contacts

Országos Korányi TBC és Pulmonológiai Intézet, Budapest 1121, Hungary

Országos Korányi TBC és Pulmonológiai Intézet, Budapest 1529, Hungary

Dong-A University Medical Center, Busan 602-715, Korea, Republic of

Asan Medical Center, Seoul 138-876, Korea, Republic of

Severance Hospital,Yonsei University Health System, Seoul 120-752, Korea, Republic of

Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu 500245, Romania

State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary", Chelaybinsk 454087, Russian Federation

Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology, Moscow 115478, Russian Federation

Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD", Moscow 129128, Russian Federation

China Medical University Hospital, Taichung 40447, Taiwan

Taichung Veterans General Hospital, Taichung 40705, Taiwan

National Taiwan University Hospital, Taipei 10002, Taiwan

Tri-Service General Hospital, Taipei 11490, Taiwan

Ironwood Cancer and Research Center, Chandler, Arizona 85224, United States

Arizona Oncology Associates, Tucson, Arizona 85715-4900, United States

Pándy Kálmán Megyei Kórház, Gyula, Bekes 5703, Hungary

University of California Irvine Medical Center, Orange, California 92868, United States

PMK Medical Group, Inc., Oxnard, California 93030, United States

Wilshire Oncology Medical Group, Inc., Rancho Cucamonga, California 91730, United States

American Institute of Research, Whittier, California 90603, United States

Institutul Oncologic "Prof. Dr. I. Chiricuta", Cluj-Napoca, Cluj 400015, Romania

Yale Cancer Center, New Haven, Connecticut 06519, United States

Florida Cancer Specialists, Fort Myers, Florida 33916, United States

Florida Cancer Specialists and Research Institute, Saint Petersburg, Florida 33705, United States

National Cancer Center, Goyang-si, Gyeonggi-do 411-769, Korea, Republic of

Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza, Sopron, Gyor-moson-sopron 9400, Hungary

Mátrai Gyógyintézet, Mátraháza, Heves 3233, Hungary

Inha University Hospital, Jung Gu, Incheon 400-711, Korea, Republic of

Central Indiana Cancer Centers, Carmel, Indiana 46032, United States

Indiana University, Indianapolis, Indiana 46202, United States

Indiana University Health Ball Memorial Hospital, Muncie, Indiana 47303, United States

Community Hospital, Munster, Indiana 46321, United States

Floyd Memorial Cancer Center of Indiana, New Albany, Indiana 47150, United States

Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do 519-763, Korea, Republic of

Owsley Brown Frazier Cancer Center-Louisville Downtown, Louisville, Kentucky 40215, United States

Tulane University, New Orleans, Louisiana 70112, United States

Spitalul de Urgenta "Constantin Opris", Baia Mare, Maramures 430031, Romania

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Ann Arbor Hematology Oncology Associates, Ann Arbor, Michigan 48158, United States

Karmanos Cancer Institute, Detroit, Michigan 48201, United States

Sparrow Regional Cancer Center, Lansing, Michigan 48912, United States

Metro Health Cancer Center, Wyoming, Michigan 49519, United States

City Oncology Hospital # 62, Moscow Region, Moscow 143423, Russian Federation

Southeast Nebraska Cancer Center, Lincoln, Nebraska 68510, United States

Broome Oncology, LLC, Johnson City, New York 13790, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 14642, United States

University of Rochester, Rochester, New York 14642, United States

Blumenthal Cancer Center, Charlotte, North Carolina 28203, United States

Piedmont Hematology Oncology Associates, PLLC, Winston Salem, North Carolina 27103, United States

Piedmont Hematology Oncology Associates, PLLC, Winston-Salem, North Carolina 27103, United States

Oncology Hematology Care, Inc., Cincinnati, Ohio 45242, United States

Signal Point Clinical Research Center, LLC, Middletown, Ohio 45042, United States

Willamette Valley Cancer Institute and Research Center, Eugene, Oregon 97401, United States

Providence Portland Medical Center, Portland, Oregon 97213, United States

Spitalul Municipal Ploiesti, Ploiesti, Prahova 100337, Romania

Charleston Hematology Oncology Associates, PA, Charleston, South Carolina 29414, United States

Cancer Centers of the Carolinas, Seneca, South Carolina 29672, United States

Chattanooga Oncology and Hematology Associates, PC, Chattanooga, Tennessee 37404, United States

Sarah Cannon Cancer Center, Nashville, Tennessee 37203, United States

Texas Oncology-Arlington South, Arlington, Texas 76014, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas 75246, United States

Texas Oncology-Tyler, Tyler, Texas 75702, United States

University of Utah Hospital and Clinics, Salt Lake City, Utah 84112, United States

Virginia Cancer Institute, Richmond, Virginia 23230, United States

Puget Sound Cancer Centers, Edmonds, Washington 98026, United States

Zala Megyei Kórház, Zalaegerszeg, Zala 8900, Hungary

Additional Information

Starting date: May 2011
Last updated: May 16, 2014

Page last updated: August 23, 2015

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