A study of an investigational drug (Ganetespib) in patients with advanced lung cancer whose cancer has a specific genetic make-up
- Conditions
- AKL positive advanced non-small cell lung cancerMedDRA version: 14.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000639-16-GB
- Lead Sponsor
- Synta Pharmaceuticals Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
1 Males or females aged 18 years or older
2 Pathological confirmation (by histology or cytology) of advanced NSCLC
a. De novo disease (i.e., 0 lines of prior therapy; stage IIIB or IV NSCLC according to the AJCC Cancer Staging Manual 7th Edition 2010
Or
b. Recurrent disease with up to 3 lines of prior systemic therapy (i.e., 1-3)
3 Histological confirmation of adenocarcinoma
4 Evidence of a translocation or an inversion event involving the ALK gene locus as determined by either a local or central laboratory, or prior documentation of ALKpositive status by a local laboratory
5 Availability of recent tumor tissue or a minimum of 10 slides of archived tumor tissue is required for ALK rearrangement confirmation testing and evaluating relevant biomarkers.
6 ECOG Performance Status 0 or 1
7 Adequate hematologic, hepatic and renal function (as defined in the protocol)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1. Prior therapy with crizotinib
2. Prior therapy with other ALK-targeted agents
3. Prior treatment with any Hsp90 inhibitor
4. Known EGFR activating mutation
5. Presence of active or untreated central nervous system (CNS) metastases as determined by magnetic resonance imaging (MRI) or computed tomography (CT) scan performed during screening or individuals who have been treated for CNS metastasis and discontinued the steroid treatment less than 4 weeks prior to Cycle 1 Day 1
6. Active malignancies other than NSCLC within the previous 2 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
7. Known serious cardiac illness (see protocol for details)
8. Prior radiotherapy to the only area of measurable disease
9. Radiotherapy within 2 weeks prior to Cycle 1 Day 1 (related radiotherapy toxicities must be = Grade 1)
10. Major surgery (unrelated to NSCLC) within 4 weeks prior to Cycle 1 Day 1
11. Women who are pregnant or lactating
12. Significant weight loss (=10% body weight) within the 4 weeks prior to Cycle 1 Day 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method