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Dasatinib, Bevacizumab, Paclitaxel in Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01015222
Recruitment Status : Active, not recruiting
First Posted : November 18, 2009
Last Update Posted : May 13, 2019
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of the combination of dasatinib, bevacizumab, and paclitaxel with or without Methylnaltrexone that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Dasatinib Drug: Bevacizumab Drug: Paclitaxel Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Dasatinib (Src Inhibitor), Bevacizumab (Anti-VEGF Monoclonal Antibody) and Metronomic Paclitaxel + or - Methylnaltrexone in Patients With Advanced Malignancies
Actual Study Start Date : November 2009
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dasatinib, Bevacizumab + Paclitaxel

Dose Escalation Starting Dose Levels: 50 mg Dasatinib daily by mouth (PO), 5 mg/kg Bevacizumab IV on Day 1 and 15; Paclitaxel 40 mg/m2 IV on Day 1, 8 and 15

Dose Expansion Starting Dose Levels: Maximum tolerated dose from Dose Escalation.

Drug: Dasatinib
Starting dose of 50 mg daily PO for 28 day cycle
Other Names:
  • BMS-354825
  • Sprycel

Drug: Bevacizumab
Starting dose 5 mg/kg IV Day 1 and 15
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

Drug: Paclitaxel
Starting dose 40 mg/m2 IV Day 1, 8 and 15
Other Name: Taxol

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment [ Time Frame: Continuous assessment during each dose level/28-day cycle ]
    MTD defined as the highest dose below any dose that has one third or more patients with dose limiting toxicities (DLT).

Secondary Outcome Measures :
  1. Antitumor Efficacy of the Combination of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment [ Time Frame: 28 days after the last dose of study drugs ]
    Participants with lymphoma measured per the WHO criteria, and all others evaluated using RECIST criteria version 1.1.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
  2. Patients must be >/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment providing radiation is not delivered to the only site of disease being treated under this protocol. After targeted/biologic therapy a patient has to be off treatment for 5 half-lives or 3 weeks whatever is shorter.
  3. ECOG performance status </= 2.
  4. Patients must have normal organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=90,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 5 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 8 X ULN.
  5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
  6. Patients must be able to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
  2. Patients with hemoptysis within 28 days prior to entering the study.
  3. Patients with clinically significant unexplained bleeding within 28 days prior to the first dose of study medication.
  4. Uncontrolled systemic vascular hypertension (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg on medication).
  5. Patients with clinically significant cardiovascular disease: history of CVA within 6 months; myocardial infarction or unstable angina within 6 months.
  6. Major surgery within 28 days prior to Day 1 of dosing Bevacizumab.
  7. Pregnant or lactating women.
  8. History of hypersensitivity to dasatinib or any component of the formulation.
  9. History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
  10. History of hypersensitivity to paclitaxel or any component of the formulation.
  11. Patients with pleural effusion which is considered clinically significant by the attending physician.
  12. Patients unwilling or unable to sign informed consent document.
  13. Social situations that would limit compliance with study requirements.
  14. Patients receiving opioids within 2 weeks before signing the consent and patients, who cannot be off opioids until initiating the study medication (for methylnaltrexone arm only).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01015222

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Filip Janku, MD,PHD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01015222     History of Changes
Other Study ID Numbers: 2009-0521
NCI-2012-01274 ( Registry Identifier: NCI CTRP )
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Advanced Malignancies
Metastatic cancer
Additional relevant MeSH terms:
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Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors
Protein Kinase Inhibitors
Enzyme Inhibitors