AKL positive advanced non-small cell lung cancer MedDRA 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
Conditions
Interventions
Product Name: Ganetespib
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 888216-25-9
Current Sponsor code: ganetespib
Sponsors
Synta Pharmaceuticals Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the objective response rate (ORR) of ganetespib in subjects with advanced ALK-positive NSCLC; Secondary Objective: Determine the overall progression-free survival (PFS), 6-month PFS and 1-year PFS. • Determine duration of response. • Determine the overall survival (OS) and 1-year OS. • Determine the disease control rate (DCR) at weeks 6 and 12. • Determine the change in tumor size (CTS) at weeks 6 and 12. • Evaluate the qualitative and quantitative toxicities associated with ganetespib in subjects with ALK-positive NSCLC. • Evaluate symptom improvement using Functional Assessment of Cancer Therapy – Lung (FACT-L) version 4. • Determine the relationship of clinical outcome with relevant biomarkers and genetic changes present in tumor tissues and serum samples. ;Primary end point(s): Objective Response Rate (ORR) (the proportion of subjects showing a complete or partial response).;Timepoint(s) of evaluation of this end point: The primary analysis of ORR will be conducted 3 months after the last subject is enrolled | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression Free Survival (PFS) Duration of Response (DOR) Overall Survival (OS) Disease Control Rate (DCR) Change in Tumor Size (CTS) Adverse Events Symptom improvement outcome Correlative Biomarker Analyses Laboratory Data Other Safety Parameters ; Timepoint(s) of evaluation of this end point: The PFS rate at 6 months and 1 year The OS rate at 1 year DCR is measured at weeks 6 and 12 CTS is measured from baseline to at least 6 weeks (CTS-6) or 12 weeks (CTS-12) | — |
Countries
Bosnia and Herzegovina, Canada, Croatia, France, Germany, Serbia, Spain, United Kingdom, United States
Contacts
Public ContactSr Clinical Trial Manager
Synta Pharmaceuticals Corp
Outcome results
None listed