Status:
TERMINATED
A Phase I/II Study of Ganetespib in Combination With Doxorubicin
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Synta Pharmaceuticals Corp.
Conditions:
Cancer
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase I/safety dose expansion study of the combination of the drug ganetespib and doxorubicin in patients with advanced solid tumors. The purpose of the Phase I part of the study is to deter...
Detailed Description
The dose escalation phase of the study will follow a standard 3+ 3 dose escalation scheme with two dose levels of ganetespib (1-- mg/m2 and 150 mg/m2) administered weekly on Days 1 and 8 of a 21-day c...
Eligibility Criteria
Inclusion
- Dose escalation phase: histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. OR safety dose expansion phase: histologically or cytologically confirmed relapsed or refractory small cell lung cancer
- No more than 3 prior lines of chemotherapy; prior therapy with doxorubicin is permitted but no more than lifetime cumulative dose of 150 mg/m2; at least 3 weeks since prior chemotherapy or radiotherapy; at least 6 weeks if the last regimen included BCNU (1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea) or mitomycin C
- Age \>/= 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- Life expectancy of greater than 3 months
- Adequate organ and marrow function
- Women of child-bearing potential must agree to avoid becoming pregnant and men must agree not to father a child for the duration of study participation.
- Ability to understand and willingness to sign a written informed consent document
Exclusion
- Chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
- Receiving any other investigational agents
- Untreated symptomatic brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ganetespib or other agents used in the study
- Receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or CYP2C18
- Left ventricular ejection fraction \< 50%
- Known serious cardiac illness or medical conditions
- uncontrolled inter-current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women
- HIV-positive on combination antiretroviral therapy
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02261805
Start Date
October 1 2014
End Date
October 1 2016
Last Update
April 23 2018
Active Locations (1)
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1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007