CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Cixutumumab +3 morebiological
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/NCT00699491
NCT00699491Phase 2Completed

Phase I/II Trial of IMC-A12 in Combination With Temsirolimus in Patients With Metastatic Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Jun 18, 2008·Updated Jun 13, 2018

In Brief

A Phase 2 clinical trial evaluating Cixutumumab, Laboratory Biomarker Analysis, and 2 other interventions for Male Breast Carcinoma and 2 related conditions. Completed, enrolled 48 participants across 192 sites.

Detailed Summary

This phase I/II trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus and to see how well they work in treating patients with breast cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other places in the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways by targeting certain cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may be a better treatment for breast cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2008
Enrollment StartOct 31, 2008
Primary CompletionSep 9, 2013
Study CompletionFeb 14, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.0 years ago

Interventions

Cixutumumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Temsirolimusdrug

Given IV