Advanced Non-Small Cell Lung Cancer Trial

Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer
MedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-000201-44-HU

Lead Sponsor: Infinity Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 210

Inclusion Criteria

• Patients must be =18 years of age or legal age of consent for the applicable country at the time of signing the Informed Consent Form (ICF).

• Patients must have NSCLC with both of the following characteristics:
- Pathologic confirmation
- Stage IIIB or IV

• Patients must have at least a =15 pack year smoking history and must have been an active smoker within 20 years of diagnosis. Number of pack years = (number of packs per day smoked) x (number of years as a smoker)

• Patients must have archival NSCLC tissue available to provide for analysis or agree to a biopsy of their NSCLC prior to study entry

• Patients must have received no more than 2 prior systemic therapy regimens (including chemotherapy alone, tyrosine kinase inhibitor therapy alone, investigational agents alone, or combination regimens) for Stage IIIb or IV disease.

• Patients must have measurable disease by RECIST 1.1 criteria. If the target lesion is in a prior irradiated field, it may be selected as long as there is documented progression (increase of 20% from baseline) either during or since radiation and the lesion is a minimum length of =10mm.

• Patients must have an ECOG performance status of 0 or 1

• Women of child-bearing potential (WCBP)

• All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

Exclusion Criteria

• Prior docetaxel, IPI-504 or other Hsp90 inhibitor (e.g., 17-AAG, DMAG, STA-9090).

• Received any of the following treatments in the specified timeframe prior to first dose of any study medication (IPI-504/ placebo or docetaxel):
within 1 week with erlotinib or gefitinib
within 2 weeks with any other tyrosine kinase inhibitor (approved or investigational)
within 2 weeks with radiation therapy
within 4 weeks with any biologic therapy (antibody, vaccine, or other protein-based therapy)
within 4 weeks with any conventional chemotherapy
within 4 weeks with investigational drug, investigational device, or approved therapy used in an investigational manner
within 6 weeks with nitrosoureas or mitomycin C.

• Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to Cycle 1, Dose 1, with the exception of dexamethasone for docetaxel premedication.
Inadequate hematologic function defined as: absolute neutrophil count (ANC) <1,500 cells/mm3
platelet count <75,000 cells/mm3
hemoglobin <9.0 g/dL (may be increased to this level with transfusion as long as there is no evidence of active bleeding).

• Inadequate hepatic function defined by:

• AST and/or ALT >1.5 x ULN
• Total bilirubin >ULN (inclusion of patients with documented Gilbert’s syndrome may be discussed with Medical Monitor)
• Alkaline phosphatase >2.5 x ULN.Patients with elevated alkaline
phosphatase are eligible if they have either:
? No liver metastases or
? Alkaline phosphatase liver fraction =2.5X ULN or
? 5´ nucleotidase =2.5X ULN or
? GGT =2.5 x ULN.

• Inadequate renal function defined by serum creatinine >1.5 x ULN.

• Patients with clinically active brain metastases (e.g., requiring therapy with steroids or radiation therapy; or with intracranial progression 4 weeks after the completion of radiation therapy) or an uncontrolled seizure disorder, ongoing spinal cord compression, or carcinomatous meningitis. Patients with clinically stable brain metastases (previously treated or untreated) are eligible.

• Sinus bradycardia (resting heart rate <50 bpm). Patients with sinus bradycardia secondary to pharmacologic therapy may enroll if discontinuation of the therapy results in normalization of the resting heart rate to within normal limits.

• Significant cardiac disease

• Previous or current malignancies at other sites within the last 2 years, with exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, or prostate cancer that does not require active treatment per National Comprehensive Cancer Network (NCCN) guidelines. Patients with localized prostate cancer with a Gleason score of 6 or less should be followed by active surveillance and are eligible for this study.

• Prior hepatic resections or hepatic-directed therapy (e.g., chemoembolization or Theresphere®).

• Known HIV-positive patients receiving combination antiretroviral therapy.

• Women who are pregnant or lactating.

• Any other condition that, in the opinion of the Investigator, may compromise the safety (including but not limited to active hepatitis or liver cirrhosis), compliance of the patient, or would preclude the patient from successful completion of the study.

• Grade 3 or 4 thromboembolic event within 1 month, unless on a stable dose of anticoagulant.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The overall survival (OS) of patients with previously treated NSCLC administered IPI-504 plus docetaxel will be compared to patients treated with placebo plus docetaxel in all patients and patients with squamous cell carcinoma (determined by central histology review).;Secondary Objective: • To compare the PFS, TTP, and ORR of all patients and patients with squamous cell carcinoma administered IPI-504 plus docetaxel versus placebo plus docetaxel <br>• To compare the safety of IPI-504 plus docetaxel versus placebo plus docetaxel <br>• To investigate potential tissue, serum, and/or plasma biomarkers of the activity of IPI-504 plus docetaxel;Primary end point(s): The primary endpoint is Overall Survival, defined as time from randomization to death due to any cause.;Timepoint(s) of evaluation of this end point: Q4 2013

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • ORR, defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Criteria in Solid Tumors (RECIST 1.1).<br><br>• PFS, defined as time from randomization to disease progression or death whichever occurs first.<br><br>• TTP, defined as time from randomization to disease progression (per RECIST 1.1)<br><br>• Incidence of adverse events (AEs)<br>• Incidence of serious adverse events (SAEs)<br>• Laboratory test results<br>• Vital sign results ;Timepoint(s) of evaluation of this end point: Final Q4 2013