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

May 26, 2011
May 16, 2014
May 2011
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01362400 on ClinicalTrials.gov Archive Site
  • 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
  • Progression Free Survival [ Time Frame: Up to three years from last patient study visit ] [ Designated as safety issue: No ]
    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 ] [ 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
Not Provided
Not Provided
 
A Double-blind Study Evaluating IPI-504 and Docetaxel in Patients With Non-Small Cell Lung Cancer
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Non Small Cell Lung Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
April 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Korea, Republic of,   Russian Federation,   Taiwan,   Romania,   Hungary
 
NCT01362400
IPI 504-14
Yes
Infinity Pharmaceuticals, Inc.
Infinity Pharmaceuticals, Inc.
Not Provided
Study Director: Tess Schmalbach, MD Infinity Pharmaceuticals, Inc.
Infinity Pharmaceuticals, Inc.
May 2014

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