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

May 16, 2014 updated by: Infinity Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Docetaxel
  • IPI-504
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 Names:
  • Docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to three years from last patient study visit
To determine the overall survival rate of patients administered IPI-504 plus docetaxel vs. placebo plus docetaxel
Up to three years from last patient study visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Up to three years from last patient study visit
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
Up to three years from last patient study visit
Overall Response Rate
Time Frame: Up to three years from last patient study visit
To determine partial response or complete response occurring at any point post-treatment
Up to three years from last patient study visit
Time to Progression
Time Frame: Up to three years from last patient study visit
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
Up to three years from last patient study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infinity Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

May 26, 2011

First Posted (ESTIMATE)

May 30, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI 504-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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