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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362400
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 26, 2011
First Posted Date  ICMJE May 30, 2011
Last Update Posted Date May 19, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
  • Progression Free Survival [ Time Frame: Up to three years from last patient study visit ]
    To determin the progression free survivial 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 ]
    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 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
Official Title  ICMJE 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
Brief 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: ARM 1: IPI 504 + Docetaxel
    Drug: IPI-504 plus Docetaxel
    Intervention: Drug: IPI 504 plus Docetaxel
  • Placebo Comparator: Placebo + Docetaxel
    Placebo plus Docetaxel
    Intervention: Drug: Placebo plus Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2012)
226
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2011)
190
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Korea, Republic of,   Romania,   Russian Federation,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01362400
Other Study ID Numbers  ICMJE IPI 504-14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Infinity Pharmaceuticals, Inc.
Study Sponsor  ICMJE Infinity Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tess Schmalbach, MD Infinity Pharmaceuticals, Inc.
PRS Account Infinity Pharmaceuticals, Inc.
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP