Status:
COMPLETED
Study of Hsp90 Inhibitor, STA-9090 for Relapsed or Refractory Small Cell Lung Cancer
Lead Sponsor:
David M. Jackman, MD
Collaborating Sponsors:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Small cell lung cancer (SCLC) is a chemotherapy and radiotherapy sensitive tumor, but with very high rates of relapse and metastasis, resulting in a very poor outcome. Among limited-stage patients, th...
Detailed Description
OBJECTIVES: Primary Objective * To determine the progression-free rate at 8 weeks in participants with relapsed or refractory small cell lung cancer who have received \<3 prior regimens of systemic ...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of small cell lung cancer and confirmed progressive disease by radiographic study
- \</= 3 prior chemotherapy regimens
- Subjects with brain metastases will be allowed if they have been treated with surgery and/or radiation therapy \> 21 days prior, are asymptomatic, and are stable for at least 1 week off steroids
- Must have measurable disease
- \>/= 18 years of age
- Life expectancy of greater than 12 weeks
- EGOG performance status 0 or 1
- Lab values must be within limits outlined in the protocol
- Not pregnant or breastfeeding
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Chemotherapy or radiotherapy within 3 weeks or within 5 half-lives of previous therapy
- History of severe allergic or hypersensitivity reactions to taxanes.
- Subjects who have not recovered from adverse events or toxicities due to agents administered more than 4 weeks earlier to a grade 1 or less
- Not receiving any other study agents
- History of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery.
- Baseline QTc \> 470 msec or previous history of QT prolongation while taking other medications.
- Ventricular ejection fraction of \< 55%.
- History or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block.
- ECG with clinically significant ventricular arrhythmias or ischemia
- Major surgery within 4 weeks of starting treatment
- Poor venous access necessitating use of indwelling catheter for IV therapy
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance
- History of another malignancy unless disease-free for 3 years and deemed to be at low risk for recurrence
Key Trial Info
Start Date :
July 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01173523
Start Date
July 28 2010
End Date
November 4 2016
Last Update
April 16 2019
Active Locations (3)
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1
Massacusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115