CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Cisplatin +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01196416
NCT01196416Phase 2Completed

Phase Ib/II Study of the Gamma-Secretase Inhibitor (GSI) RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma

National Cancer Institute (NCI)·interventional·Posted Sep 8, 2010·Updated Nov 18, 2019

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Gamma-Secretase Inhibitor RO4929097, and 4 other interventions for Recurrent Melanoma and Stage IV Skin Melanoma. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This phase Ib/II trial studies the side effects and best dose of gamma-secretase/Notch signalling pathway inhibitor RO4929097 when given together with cisplatin, vinblastine, and temozolomide and to see how well they work in treating patients with recurrent or metastatic melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, vinblastine, and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gamma-secretase/Notch signalling pathway inhibitor RO4929097 together with combination chemotherapy may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 8, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 15.8 years ago

Interventions

Cisplatindrug

Given IV

Gamma-Secretase Inhibitor RO4929097drug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Temozolomidedrug

Given PO

Vinblastine Sulfatedrug

Given IV