At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 21 enrolled

Drug / intervention

ABI-007 +2 moredrug

Likely dose

ABI-007 150 mg/m2from 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/NCT01827111

NCT01827111Phase 2Completed

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Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma

M.D. Anderson Cancer Center·interventional·Posted Apr 9, 2013·Updated Feb 8, 2022

In Brief

A Phase 2 clinical trial evaluating ABI-007, Ipilimumab, and 1 other intervention for Melanoma. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied. Ipilimumab is designed to increase the immune system's ability to fight cancer. Abraxane is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMelanoma

CountriesUnited States

CollaboratorsCelgene

Timeline

Phase 2CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedApr 2013

Enrollment StartApr 2013

Primary CompletionSep 2020

TodayJul 2026

First PostedApr 9, 2013

Enrollment StartApr 25, 2013

Primary CompletionSep 21, 2020

TodayJul 2, 2026

Enrollment to primary: 7.4 yearsPosted 13.2 years ago

Interventions

ABI-007drug

Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.

Ipilimumabdrug

3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.

Phone Callbehavioral

Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.