A study to assess the effect of Ganetespib (study drug) in combination with Docetaxel versus Docetaxel alone in patients with advanced Non-Small Cell Lung Cancer
- Conditions
- on-Small Cell Lung CancerMedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001084-42-BE
- Lead Sponsor
- Synta Pharmaceutical Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
1. Male or female subjects aged 18 years or older
2. Pathologically confirmed (by histology or cytology) diagnosis of NSCLC with predominantly adenocarcinoma histology
3. Stage IIIB or IV NSCLC according to the AJCC Cancer Staging Manual 7th Edition 2010
4. ECOG Performance Status 0 or 1 and life expectancy of at least 3 months at screening
5. Eligible for second-line systemic therapy:
•Patients must have received no more than one prior therapy (first-line therapy) for advanced disease (Stage IIIB or IV). Prior first-line therapy may include:
i. A platinum-based chemotherapy doublet (with or without biological agents); or
ii. EGFR tyrosine kinase inhibitors (TKIs) for EGFR-mutated disease
•NOTE: Maintenance therapy following first-line treatment for advanced disease is allowed, as long as it was started no more than 4 weeks after the last dose of first-line therapy
•NOTE: Previous anticancer treatment must have stopped at least 2 weeks prior to randomization
6. Measurable disease by modified RECIST 1.1
7. Radiologic evidence of primary or secondary disease progression following first-line treatment.
Disease progression is defined as:
•Appearance of any new lesion or any measureable increase of one or more existing lesions. Radiological scans or radiology reports from the subject's most recent treatment must document the baseline or lowest
tumor burden (nadir scans) and disease progression.
NOTE: Disease progression is defined either as a primary progression where a patient never responded to first line treatment; or secondary progression, where disease progression occurred after initial response
8. Subjects with CNS metastases are eligible, provided that the CNS metastases are radiologically and clinically stable for at least 4 weeks after appropriate therapy (with or without steroid treatment) prior to
randomization
9. Adequate hematologic function defined as:
• Absolute neutrophil count (ANC) = 1.5 × 109/L
• Hemoglobin = 9 g/dL
• Platelets = 100 × 109/L
10. Adequate hepatic function defined as:
• Albumin =3 g/dL
• Serum total bilirubin =1.5 x ULN
• AST and ALT =1.5 × ULN without liver metastases; =5 × ULN if documented liver metastases
11. Adequate renal function defined as
• Serum Creatinine =1.2 mg/dL or calculated creatinine clearance (CLcr) per Cockgroft- Gault formula = 50mL/min
12. Negative serum pregnancy test at study entry for female subjects of childbearing potential
13. Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 30 days after the last dose of study drug.
14. Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
15. Translational Research: archived or newly obtained tumor tissue, consisting of at least 10 unstained slides or a block of fixed tumor tissue, must be collected prior to randomization
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 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360
1. Presence of active or untreated CNS metastases as determined by MRI or CT scan performed during screening.
2. Active malignancies other than NSCLC within the last 5 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
3. Serious cardiac illness or medical conditions including but not confined to:
• History of documented congestive heart failure (CHF), New York Heart Association
class II/III/IV, with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor
blockers, beta-blockers or diuretics. NOTE: Use of these medications for the treatment of hypertension is allowed
• Baseline QTc > 470 msec or history of QT prolongation while taking other medications
• High-risk uncontrolled arrhythmias (ventricular tachycardia, high-Grade AV-block, supra-ventricular arrhythmias which are not adequately rate-controlled) that require current treatment with the following anti-arrythmic drugs: flecainide, moricizine or propafenone
• Current coronary artery disease with a history of myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
4. Radiotherapy within 2 weeks prior to randomization (related toxicities must be =Grade 1)
5. Prior radiotherapy to the only area of measurable disease
6. Major surgery (unrelated to NSCLC) within 4 weeks prior to randomization
7. Hemoptysis = Grade 2 at randomization
8. Peripheral neuropathy = Grade 2 at randomization
9. History of severe allergic or hypersensitivity reactions to docetaxel or excipients (eg,
polyethylene glycol [PEG] 300 and polysorbate 80)
10. Women who are pregnant or lactating
11. Significant weight loss of = 10% body weight within the 4 weeks prior to randomization
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