Study Stopped
Company terminated drug support
A Phase I/II Study of Ganetespib in Combination With Doxorubicin
1 other identifier
interventional
11
1 country
1
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 determine the recommended phase II dose of ganetespib when given in combination with doxorubicin. The recommended Phase II dose determined at the end of the dose escalation phase will be used to conduct a safety dose expansion phase in relapsed/refractory small cell lung cancer to determine if there is a signal of efficacy in this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 cancer
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 7, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
February 7, 2018
CompletedApril 23, 2018
March 1, 2018
2 years
October 7, 2014
January 12, 2018
March 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose
The dose of ganetespib at which 1 or more out of 3-6 patients experiences a dose-limiting toxicity
1 year
Secondary Outcomes (1)
Objective Response Rate
2 years
Study Arms (3)
Ganetespib and doxorubicin - Phase Ib Dose Level 1
EXPERIMENTALGanetespib 100 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
Ganetespib and doxorubicin - Phase Ib Dose Level 2
EXPERIMENTALGanetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
Ganetespib and doxorubicin - Phase II Expansion
EXPERIMENTALGanetespib 150 mg/m2 IV on days 1 and 8 of a 21-day cycle Doxorubicin 50 mg/m2 IV on day 1 of a 21-day cycle
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- Synta Pharmaceuticals Corp.collaborator
Study Sites (1)
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
Related Publications (1)
Subramaniam DS, Liu SV, Crawford J, Kramer J, Thompson J, Wang H, Giaccone G. A Phase Ib/II Study of Ganetespib With Doxorubicin in Advanced Solid Tumors Including Relapsed-Refractory Small Cell Lung Cancer. Front Oncol. 2018 Mar 12;8:64. doi: 10.3389/fonc.2018.00064. eCollection 2018.
PMID: 29594044DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Giuseppe Giaccone
- Organization
- Lombardi Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Giaccone, MD PhD
Georgetown University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2014
First Posted
October 10, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
April 23, 2018
Results First Posted
February 7, 2018
Record last verified: 2018-03