NCT01015222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

11.6 years

First QC Date

November 17, 2009

Last Update Submit

November 21, 2022

Conditions

Advanced Cancer

Keywords

Advanced MalignanciesMetastatic cancerBevacizumabAvastinDasatinibSprycelPaclitaxelTaxol

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment

    MTD defined as the highest dose below any dose that has one third or more patients with dose limiting toxicities (DLT).

    Continuous assessment during each dose level/28-day cycle

Secondary Outcomes (1)

  • Antitumor Efficacy of the Combination of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment

    28 days after the last dose of study drugs

Study Arms (1)

Dasatinib, Bevacizumab + Paclitaxel

EXPERIMENTAL

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: DasatinibDrug: BevacizumabDrug: Paclitaxel

Interventions

DasatinibDRUG

Starting dose of 50 mg daily PO for 28 day cycle

Also known as: BMS-354825, Sprycel
Dasatinib, Bevacizumab + Paclitaxel
BevacizumabDRUG

Starting dose 5 mg/kg IV Day 1 and 15

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Dasatinib, Bevacizumab + Paclitaxel
PaclitaxelDRUG

Starting dose 40 mg/m2 IV Day 1, 8 and 15

Also known as: Taxol
Dasatinib, Bevacizumab + Paclitaxel

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • ECOG performance status \</= 2.
  • 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.
  • 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.
  • Patients must be able to understand and be willing to sign a written informed consent document.

You may not qualify if:

  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
  • Patients with hemoptysis within 28 days prior to entering the study.
  • Patients with clinically significant unexplained bleeding within 28 days prior to the first dose of study medication.
  • Uncontrolled systemic vascular hypertension (systolic blood pressure \> 140mmHg, diastolic blood pressure \> 90mmHg on medication).
  • Patients with clinically significant cardiovascular disease: history of CVA within 6 months; myocardial infarction or unstable angina within 6 months.
  • Major surgery within 28 days prior to Day 1 of dosing Bevacizumab.
  • Pregnant or lactating women.
  • History of hypersensitivity to dasatinib or any component of the formulation.
  • History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
  • History of hypersensitivity to paclitaxel or any component of the formulation.
  • Patients with pleural effusion which is considered clinically significant by the attending physician.
  • Patients unwilling or unable to sign informed consent document.
  • Social situations that would limit compliance with study requirements.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

DasatinibBevacizumabPaclitaxel

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Filip Janku, MD,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

November 1, 2009

Primary Completion

May 27, 2021

Study Completion

May 27, 2021

Last Updated

November 23, 2022

Record last verified: 2022-11

Locations

US(1)