MedTrace Logo

Dasatinib in Combination With Bevacizumab to Treat Advanced Solid Tumors

NCT01445509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

* Bevacizumab inhibits blood vessel growth in cancer cells by blocking a growth factor called VEGF. Dasatinib inhibits the action of proteins called tyrosine kinases, which promote and stimulate blood vessel formation and cancer growth and spread.
* Using the two drugs in combination may provide a more effective cancer treatment than either drug used alone.
* Both drugs have been approved by the Food and Drug Administration for different cancer types, but their use in combination sis experimental.

Objectives:

\- To determine the highest doses of the combination of dasatinib and bevacizumab that can be safely given to patients with different cancers and to find out what effects, good and bad, these drugs may have on the patient and the disease.

Eligibility:

\- Adult patients with an advanced solid tumor cancer that cannot be treated successfully with standard therapies.

Design:

* Patients in Group 1 receive dasatinib and bevacizumab together throughout the study. The dose is increased in successive groups of three to six patients until the optimum safe dose is determined. Patients take dasatinib by mouth once a day and receive bevacizumab as an infusion through a vein once every 2 weeks in 28-day treatment cycles.
* Patients in Group 2 are randomly assigned to receive either dasatinib or bevacizumab for cycle one, and then both drugs for all subsequent cycles. The drug doses are based on the optimum doses found in Group 1 patients.
* Patients have a physical examination and blood and urine tests every 2 weeks for cycles 1 and 2, and then every 4 weeks for the duration of treatment.
* Patients have CT or MRI scans or another imaging test such as ultrasound every 8 weeks to monitor the cancer s response to treatment.
* Tumor biopsies are obtained from patients in Group 2 before treatment, 2 weeks into the first treatment cycle, and 2 weeks into the second cycle.
* Dynamic, contrast-enhanced MRI (DCE-MRI) tests are done on patients in Group 2 before treatment, 2 weeks into the first cycle and 4 weeks into the second cycle. This MRI test uses a special non-radioactive dye that shows blood flow in a certain part of the body.
* For patients who have been on the study over 2 years, the cycle may be lengthened to 6 or 8 weeks at the discretion of the investigator.

Conditions

Interventions

DRUG

Bevacizumab

Once the MTD of dasatinib with bevacizumab 5 mg/kg IV every two weeks is determined, one final dose level will be accrued with that MTD dose of dasatinib with bevacizumab at 10 mg/kg IV every two weeks in order to determine if we can safely escalate bevacizumab to full dose with dasatinib concurrently.

DRUG

Dasatinib

We will start dasatinib at 50 mg PO QD which is less than half the recommended Phase 2 dose as well as bevacizumab at 5 mg/kg IV every two weeks, which is half the single agent dose. If this is well-tolerated, study drugs will be escalated per schema to maximize the dose of dasatinib when given concurrently.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Stanley Lipkowitz, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-29
Primary Completion
2017-12-18
Completion
2018-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01445509 on ClinicalTrials.gov