NCT01445509

Dasatinib in Combination With Bevacizumab to Treat Advanced Solid Tumors

Completed Phase 1 Last updated 6 April 2026

What this trial tests

Phase 1 trial testing Bevacizumab in Solid Tumors in 50 participants. Completed in 20 September 2018.

Timeline

29 December 2008

Primary endpoint
18 December 2017

20 September 2018

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	29 December 2008
Primary completion	18 December 2017
Estimated completion	20 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• Dasatinib (dasatinib) — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of c-Src in Carcinogenesis and Drug Resistance.
   Raji L, Tetteh A, Amin ARMR. · · 2023 · cited 35× · PMID 38201459 · DOI 10.3390/cancers16010032
2. Leveraging locus-specific epigenetic heterogeneity to improve the performance of blood-based DNA methylation biomarkers.
   Miller BF, Pisanic Ii TR, Margolin G, Petrykowska HM, et al · · 2020 · cited 13× · PMID 33081832 · DOI 10.1186/s13148-020-00939-w
3. Caspase-8 and Tyrosine Kinases: A Dangerous Liaison in Cancer.
   Contadini C, Ferri A, Cirotti C, Stupack D, et al · · 2023 · cited 11× · PMID 37444381 · DOI 10.3390/cancers15133271