EUCTR2011-001084-42-ES
Active, not recruiting
Not Applicable
A Randomized, Phase IIb/III Study of Ganetespib (STA-9090) in Combination with Docetaxel versus Docetaxel alone in Subjects with Stage IIIb or IV Non-Small Cell Lung Cancer
Synta Pharmaceutical Corp.0 sites740 target enrollmentJuly 12, 2011
Conditionson-Small Cell Lung CancerMedDRA version: 14.0Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: 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]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- on-Small Cell Lung Cancer
- Sponsor
- Synta Pharmaceutical Corp.
- Enrollment
- 740
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subjects aged 18 years or older
- •2\. Pathologically confirmed diagnosis of NSCLC
- •3\. Stage IIIB or IV NSCLC
- •4\. ECOG Performance Status 0 or 1
- •5\. Prior therapy defined as:
- •? One prior systemic therapy for advanced disease that includes:
- •i. A platinum\-based chemotherapy; or
- •ii. EGFR tyrosine kinase inhibitors (TKIs) in EGFR\-mutated disease
- •? NOTE: Approved maintenance therapy (e.g., pemetrexed) is allowed provided that it was started no more than 4 weeks after the last dose of prior therapy for advanced disease. Prior adjuvant or neoadjuvant therapy for early stage disease is allowed
- •? NOTE: Previous anticancer treatment must have stopped at least 2 weeks prior to randomization
Exclusion Criteria
- •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
- •? Left ventricular ejection fraction (LVEF) \< 50 % at baseline
- •? 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
Outcomes
Primary Outcomes
Not specified
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