drugset
drugset / Trial / NCT01841463

Study of an Oral Cdk Inhibitor Administered With an Oral BRAF Inhibitor in Patients With Advanced or Inoperable Malignant Melanoma With BRAF Mutation

NCT01841463 ↗

Phase 1 Suspended 100 enrolled Piramal Enterprises Limited Melanoma Research Foundation Breakthrough Consortium · collab
NaSingle-groupOpen-labelTreatment

Summary

* An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients with Advanced or Inoperable Malignant Melanoma with BRAF Mutation * The primary objective is to determine the safety, maximum tolerated dose (MTD), and dose limiting toxicity (DLT) of the co-administration of P1446A-05 with vemurafenib, in melanoma patients with BRAF mutation

Timeline

Start
2013-08
Primary completion
2015-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject P1446A-05 Unknown 150 mg Oral
Subject P1446A-05 Unknown 250 mg Oral
Subject P1446A-05 Unknown 350 mg Oral
Subject Vemurafenib Small molecule 720 mg Oral
Subject Vemurafenib Small molecule 960 mg Oral

Indications

melanoma