CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
GTI-2040 +1 morebiological
Likely dose
GTI-2040 IV in combination with capecitabine orally (specific dose not provided in interventions)AI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed metastatic adenocarcinoma of the breast
  • ✓Measurable disease: ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • ✓Progressed on 1-2 prior chemotherapy regimens for metastatic disease; no prior capecitabine or 5-fluorouracil
  • ✓HER-2+ patients should have received trastuzumab (Herceptin) in adjuvant or metastatic setting unless contraindicated
Key exclusion· 7
  • ✕Only non-measurable disease (bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis, unconfirmed abdominal masses, cystic lesions)
  • ✕Known brain metastases
  • ✕Prior GTI-2040 therapy
  • ✕History of allergic reactions to GTI-2040, capecitabine, or 5-fluorouracil

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

Search/NCT00068588
NCT00068588Phase 2Completed
CompareCT.gov

A Phase 2 Study of GTI-2040 (NSC 722929) in Combination With Capecitabine in Metastatic Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Sep 11, 2003·Updated Oct 31, 2014

In Brief

A Phase 2 clinical trial evaluating GTI-2040 and capecitabine for Male Breast Cancer and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving GTI-2040 together with capecitabine works in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may help capecitabine kill more tumor cells by making them more sensitive to the drug

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2003
Enrollment StartOct 1, 2003
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 22.8 years ago

Interventions

GTI-2040biological

Given IV

capecitabinedrug

Given orally