CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Axitinib +2 moredrug
Likely dose
Axitinib 5mgfrom 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/NCT01174238
NCT01174238Phase 2Completed
CompareCT.gov

A Two Arm Phase II Trial of Sequential Axitinib and Carboplatin/Paclitaxel in Melanoma With Correlative FLT PET Scans (3'Deoxy-3'-18F-Fluorothymidine Positron Emission Tomography Scans)(CC# 10852)

Adil Daud·interventional·Posted Aug 3, 2010·Updated Jun 8, 2018

In Brief

A Phase 2 clinical trial evaluating Axitinib, Carboplatin, and 1 other intervention for Melanoma. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This is a two arm prospective Phase II pilot trial designed to determine the optimal duration of break between axitinib and chemotherapy with carboplatin/paclitaxel in melanoma. In this study, 6 patients will be enrolled to Arm A, the FLT PET scan (3'deoxy-3'-18F-Fluorothymidine positron emission tomography scans)cohort. 30 patients will be enrolled to Arm B, the treatment-only cohort. 36 total patients will be enrolled. The treatment schedule will be the same in either cohort, with the exception of the FLT PET scans.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 3, 2010
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.9 years ago

Interventions

Axitinibdrug

5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy

Carboplatindrug

Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase

Paclitaxeldrug

Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.