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Doxycycline with Temozolomide and Ipilimumab in Metastatic Melanoma
NCT01590082Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2012
- Primary completion
- Jul 2015
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Drugs
- doxycycline
- Conditions
- melanoma
01
Overview
Phase 2, open-label, single-arm trial of doxycycline in melanoma, sponsored by University of Texas MD Anderson Cancer Center. Primary endpoints: Overall Participant Response up to 7 weeks and Maximum Tolerated Dose at Cycle 1. Started Nov 2012; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Doxycycline, Ipilimumab, and Temozolomide
Combination therapy followed by Doxycycline maintenance
03
Who it enrols
Patients must have metastatic melanoma. For Phase II, tumors must have >25% iNOS expression and patients must not have received prior ipilimumab or more than 1 prior chemotherapy regimen. Patients with ocular melanoma are excluded from Phase II.
04
Endpoints
Primary
Overall Participant Response
Maximum Tolerated Dose
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