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

  Show 66 Study Locations
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014