Clinical trial · Interventional
A Phase I/II Study of Ganetespib in Combination With Doxorubicin
A Phase I/II Study of Ganetespib in Combination With Doxorubicin in Solid Tumors (Phase I) and Refractory Small Cell Lung Cancer (Safety Dose Expansion, Phase II)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company terminated drug support
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Ganetespib | Drug | Ganetespib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Ganetespib and doxorubicin - Phase Ib Dose Level 1
- description
- Ganetespib 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
- interventionNames
- Drug: Ganetespib
- Drug: Doxorubicin
- type
- EXPERIMENTAL
- label
- Ganetespib and doxorubicin - Phase Ib Dose Level 2
- description
- Ganetespib 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
- interventionNames
- Drug: Ganetespib
- Drug: Doxorubicin
- type
- EXPERIMENTAL
- label
- Ganetespib and doxorubicin - Phase II Expansion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- DERIVEDSubramaniam 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 29594044