SuspendedPhase 1

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

Stopped: Sponsor decision not related to patient safety

United States100 participantsStarted 2013-08

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients having histologically confirmed unresectable (Stage III) or metastatic (Stage IV) malignant melanoma with a positive BRAF mutation result determined by Roche CoDx or local CLIA-certified analysis
✓. Patients naïve to a selective BRAF inhibitor therapy or must have progressed after therapy on a selective BRAF inhibitor. For patients entering the protocol progressing on vemurafenib therapy, they must be tolerant of the 960 mg po bid dose.
✓. Tumor biopsies are optional in this study except for patients entering the mandatory biopsy cohorts. Nevertheless tumor biopsies are encouraged, especially in patients with accessible tumors for biopsy to include the collection of formalin-fixed, paraffin-embedded (FFPE) and fresh- frozen tissue (FF) as outlined in the biomarker sections of the protocol. Willingness of patient to give consent of biopsy, should be ascertained
✓. Patients of ≥ 18 years of age
✓. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or1
✓. Patients with measurable disease per 'Response Evaluation Criteria In Solid Tumors' (RECIST version 1.1)
✓. Patients must have normal organ and adequate marrow function
✓. Patients with ability to swallow and retain oral medication

What they're measuring

Maximum Tolerated Dose and Dose Limiting Toxicity

Timeframe: Until disease progression or unacceptable toxicity (expected to be 6-8 months)

Trial details

NCT IDNCT01841463

SponsorPiramal Enterprises Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03

View on ClinicalTrials.gov More Advanced or Inoperable Malignant Melanoma With BRAF Mutation trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients having histologically confirmed unresectable (Stage III) or metastatic (Stage IV) malignant melanoma with a positive BRAF mutation result determined by Roche CoDx or local CLIA-certified analysis
✓. Patients naïve to a selective BRAF inhibitor therapy or must have progressed after therapy on a selective BRAF inhibitor. For patients entering the protocol progressing on vemurafenib therapy, they must be tolerant of the 960 mg po bid dose.
✓. Tumor biopsies are optional in this study except for patients entering the mandatory biopsy cohorts. Nevertheless tumor biopsies are encouraged, especially in patients with accessible tumors for biopsy to include the collection of formalin-fixed, paraffin-embedded (FFPE) and fresh- frozen tissue (FF) as outlined in the biomarker sections of the protocol. Willingness of patient to give consent of biopsy, should be ascertained
✓. Patients of ≥ 18 years of age
✓. Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or1
✓. Patients with measurable disease per 'Response Evaluation Criteria In Solid Tumors' (RECIST version 1.1)
✓. Patients must have normal organ and adequate marrow function
✓. Patients with ability to swallow and retain oral medication

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria