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Dasatinib and Crizotinib in Advanced Cancer

NCT01744652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-06-07

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of dasatinib and crizotinib that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.

Dasatinib is designed to block certain proteins from causing cancer cells to grow out of control. This may cause the cancer cells to die.

Crizotinib is designed to block certain abnormal genes found in cancer cells. This may cause the cancer cells to die.

This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of leukemia. Crizotinib is FDA approved and commercially available for the treatment of lung cancer. The combination of dasatinib and crizotinib is currently being used for research purposes only.

Up to 176 participants will take part in this study. All will be enrolled at MD Anderson

Conditions

Interventions

DRUG

Crizotinib

Arm A Crizotinib dose: 250 mg by mouth twice a day in a 28 day cycle. Crizotinib Expansion dose: 250 mg by mouth twice a day in a 28 day cycle. Arm B Crizotinib starting dose: 250 mg by mouth every other day in a 28 day cycle. Crizotinib Expansion Dose: MTD from dose escalation group.

DRUG

Dasatinib

Arm A Dasatinib starting dose: 50 mg by mouth daily in a 28 day cycle. Arm A Dasatinib Expansion Dose: MTD from dose escalation group. Arm B Dasatinib dose: 140 mg by mouth daily in a 28 day cycle. Arm B Dasatinib Expansion Dose: 140 mg by mouth daily in a 28 day cycle.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David S. Hong, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2019-03-31
Completion
2019-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01744652 on ClinicalTrials.gov