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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Mátrai Gyógyintézet
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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