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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01362400
First received: May 26, 2011
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: IPI 504 plus Docetaxel
Drug: Placebo plus Docetaxel
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Up to three years from last patient study visit ] [ Designated as safety issue: No ]
    To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to three years from last patient study visit ] [ Designated as safety issue: No ]
    To determine the progression free survival rate from randomization to progression or death whichever occurs first, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel

  • Overall Response Rate [ Time Frame: Up to three years from last patient study visit ] [ Designated as safety issue: No ]
    To determine partial response or complete response occurring at any point post-treatment

  • Time to Progression [ Time Frame: Up to three years from last patient study visit ] [ Designated as safety issue: No ]
    To identify the amount of time from randomization to progression, of all patients and in a subpopulation of patients administered IPI-504 plus docetaxel versus placebo plus docetaxel


Enrollment: 226
Study Start Date: May 2011
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ARM 1: IPI 504 + Docetaxel
Drug: IPI-504 plus Docetaxel
Drug: IPI 504 plus Docetaxel

450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 & 15 during each 21 day cycle

75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)

Other Names:
  • IPI-504
  • Docetaxel
Placebo Comparator: Placebo + Docetaxel
Placebo plus Docetaxel
Drug: Placebo plus Docetaxel

450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 & 15 during each 21 day cycle

75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)

Other Name: Docetaxel

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362400

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
Arizona Oncology Associates
Tucson, Arizona, United States, 85715-4900
United States, California
University of California Irvine Medical Center
Orange, California, United States, 92868
PMK Medical Group, Inc.
Oxnard, California, United States, 93030
Wilshire Oncology Medical Group, Inc.
Rancho Cucamonga, California, United States, 91730
American Institute of Research
Whittier, California, United States, 90603
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06519
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists and Research Institute
Saint Petersburg, Florida, United States, 33705
United States, Indiana
Central Indiana Cancer Centers
Carmel, Indiana, United States, 46032
Indiana University
Indianapolis, Indiana, United States, 46202
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, United States, 47303
Community Hospital
Munster, Indiana, United States, 46321
Floyd Memorial Cancer Center of Indiana
New Albany, Indiana, United States, 47150
United States, Kentucky
Owsley Brown Frazier Cancer Center-Louisville Downtown
Louisville, Kentucky, United States, 40215
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Ann Arbor Hematology Oncology Associates
Ann Arbor, Michigan, United States, 48158
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912
Metro Health Cancer Center
Wyoming, Michigan, United States, 49519
United States, Nebraska
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
United States, New York
Broome Oncology, LLC
Johnson City, New York, United States, 13790
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 14642
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28203
Piedmont Hematology Oncology Associates, PLLC
Winston Salem, North Carolina, United States, 27103
Piedmont Hematology Oncology Associates, PLLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
United States, Oregon
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, South Carolina
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States, 29414
Cancer Centers of the Carolinas
Seneca, South Carolina, United States, 29672
United States, Tennessee
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology-Arlington South
Arlington, Texas, United States, 76014
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology-Tyler
Tyler, Texas, United States, 75702
United States, Utah
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States, 84112
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Puget Sound Cancer Centers
Edmonds, Washington, United States, 98026
Hungary
Pándy Kálmán Megyei Kórház
Gyula, Bekes, Hungary, 5703
Sopron MJV Erzsébet Kórház, A DEOEC Oktató Kórháza
Sopron, Gyor-moson-sopron, Hungary, 9400
Mátrai Gyógyintézet
Mátraháza, Heves, Hungary, 3233
Zala Megyei Kórház
Zalaegerszeg, Zala, Hungary, 8900
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, Hungary, 1121
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, Hungary, 1529
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
Inha University Hospital
Jung Gu, Incheon, Korea, Republic of, 400-711
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, Korea, Republic of, 519-763
Dong-A University Medical Center
Busan, Korea, Republic of, 602-715
Severance Hospital,Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Asan Medical Center
Seoul, Korea, Republic of, 138-876
Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta"
Cluj-Napoca, Cluj, Romania, 400015
Spitalul de Urgenta "Constantin Opris"
Baia Mare, Maramures, Romania, 430031
Spitalul Municipal Ploiesti
Ploiesti, Prahova, Romania, 100337
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Romania, 500245
Russian Federation
City Oncology Hospital # 62
Moscow Region, Moscow, Russian Federation, 143423
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
Chelaybinsk, Russian Federation, 454087
Blokhin Cancer Research Center of Russia, Dept. of clinical pharmacology
Moscow, Russian Federation, 115478
Non-State Central Clinical Hospital # 2 named N.A. Semashko of "OAO RGD"
Moscow, Russian Federation, 129128
Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Taiwan University Hospital
Taipei, Taiwan, 10002
Tri-Service General Hospital
Taipei, Taiwan, 11490
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
Study Director: Tess Schmalbach, MD Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01362400     History of Changes
Other Study ID Numbers: IPI 504-14
Study First Received: May 26, 2011
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:
LUNG NEOPLASMS
LARGE CELL CARCINOMA
SQUAMOUS CELL CARCINOMA

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014