Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2011-001084-42-HU
EUCTR2011-001084-42-HU
Active, not recruiting
Phase 1

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 sites385 target enrollmentMay 23, 2011
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Synta Pharmaceutical Corp.
Enrollment
385
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 23, 2011
End Date
November 4, 2015
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Synta Pharmaceutical Corp.

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

Similar Trials

Active, not recruiting
Not Applicable
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 Canceron-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]
EUCTR2011-001084-42-ESSynta Pharmaceutical Corp.740
Active, not recruiting
Not Applicable
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 Canceron-Small Cell Lung CancerMedDRA version: 17.0Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2011-001084-42-DESynta Pharmaceutical Corp.900
Active, not recruiting
Not Applicable
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
EUCTR2011-001084-42-PLSynta Pharmaceuticals Corp.900
Active, not recruiting
Phase 1
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 Canceron-Small Cell Lung CancerMedDRA version: 14.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 100000004864MedDRA version: 14.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2011-001084-42-GBSynta Pharmaceuticals Corp.385
Active, not recruiting
Not Applicable
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 Canceron-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]
EUCTR2011-001084-42-CZSynta Pharmaceuticals Corp.900