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

Infinity Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Placebo plus Docetaxel

Drug: IPI 504 plus Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01362400

IPI 504-14

Details and patient eligibility

About

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

Full 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.

Enrollment

226 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.