Treatment of a Resistant Disease Using Decitabine Combined With Vemurafenib Plus Cobimetinib

Phase 1

Terminated

• Conditions: Melanoma; BRAF-mutated Metastatic Melanoma; Metastatic Melanoma; V600EBRAF-mutated Metastatic Melanoma
• Interventions: Drug: Vemurafenib + Cobimetinib, Decitabine

• Registration Number: NCT01876641
• Lead Sponsor: Mohammed M Milhem

Brief Summary

The purpose of this study is to see if the combination of Vemurafenib with Decitabine plus Cobimetinib improves the low therapy response rate in subjects with malignant melanoma.

Detailed Description

The primary objective of the Phase I portion of this study is to evaluate the safety and tolerability of the proposed schedule of decitabine and Vemurafenib plus Cobimetinib in the treatment of metastatic melanoma.

Study Timeline

• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-12
• Study Start: 2013-10
• Primary Completion: 2018-06
• Status Verified: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Treatment	Vemurafenib + Cobimetinib, Decitabine	In Cohorts 1-4, a subcutaneous dose of decitabine will be administered three times/week over a 2 week period. Cohorts 5 and 6 will receive decitabine two times a week for 8 weeks and Cohorts 7 and 8 will receive decitabine three times a week for 8 weeks. Patients will start treatment with decitabine initially at the cohort in which they enter the study. Patients will remain in the cohort in which they were initially enrolled for the entire treatment course. Vemurafenib + Cobimetinib will be given continuously for subjects in Cohorts 5, 6, 7 and 8. Vemurafenib will be given on a 28-day cycle at the standard dose of 960 mg p.o. BID. Cobimetinib will be given on a 21-day cycle with a 7-day rest between cycles. Decitabine will be given for 2 cycles only. Each cycle will be 28 days long. Vemurafenib + Cobimetinib will be continued indefinitely until disease progression.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities per CTCAE 4.0	From Day 1 - 28 of a 28 day cycle	Toxicity will be assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4). Toxicity will be decided after administration of one full cycle for patients.

Trial Locations

Locations (1)

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States