At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 31 enrolled

Drug / intervention

Dasatinib +1 moredrug

Likely dose

Dasatinib 100 mgfrom 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/NCT00566618

NCT00566618Phase 2Completed

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Phase I/II Study of Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis

M.D. Anderson Cancer Center·interventional·Posted Dec 3, 2007·Updated Feb 25, 2022

In Brief

A Phase 2 clinical trial evaluating Dasatinib and Zoledronic Acid for Breast Cancer and Bone Metastases. Completed, enrolled 31 participants across 3 sites.

Detailed Summary

The goal of this clinical research study is to find the highest tolerable dose of dasatinib and Zometa (zoledronic acid) that can be given in combination for the treatment of breast cancer that has spread to the bone. The safety and effectiveness of this combination will also be studied.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer, Bone Metastases

CountriesUnited States

CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 2007

First PostedDec 2007

Primary CompletionNov 2020

TodayJul 2026

First PostedDec 3, 2007

Enrollment StartNov 1, 2007

Primary CompletionNov 17, 2020

TodayJul 2, 2026

Enrollment to primary: 13.0 yearsPosted 18.6 years ago

Interventions

Dasatinibdrug

Phase I: First Cohort = 100 mg PO Daily x 28 days; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort. Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I.

Zoledronic Aciddrug

Phase I: First Cohort = 4 mg IV Over 15 min. every 4 Weeks; Next Cohort = Dose Expansion or Reduction Based on Dose Limiting Toxicity (DLT) in Initial Cohort. Phase II: Recommended Phase II Dose (RP2D) as determined with Phase I.