Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Solid Tumors Using Ixabepilone and Dasatinib

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Washington Hospital Center
ClinicalTrials.gov Identifier:
NCT00717704
First received: July 15, 2008
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

Patients are being asked to take part in this study because they have been diagnosed with an advanced solid tumor that is not responding to standard treatments. This study will find the highest dose of ixabepilone and dasatinib in combination that can be given without causing severe side effects.

Both ixabepilone and dasatinib have individually been tested in many (several thousand) patients, however the combination of the two drugs has not yet been tested in humans.

All patients who will take part in this study will receive combined drug therapy of dasatinib and ixabepilone. Dasatinib is a pill that is taken by mouth. Ixabepilone is a medicine that will be given by vein (IV).

All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily.


Condition Intervention Phase
Solid Tumor
Drug: ixabepilone
Drug: Dasatinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Ixabepilone Combined With Dasatinib in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Washington Hospital Center:

Primary Outcome Measures:
  • The primary outcome is to determine the safety and toxicity of ixabepilone and dasatinib in combination in patients with metastatic or locally advanced/unresectable solid tumors that have progressed through standard therapy. [ Time Frame: From study start until completion of study followup. This can vary greatly between patients, but on average patients received treatment for 4 cycles (12 weeks). ] [ Designated as safety issue: Yes ]
    While on the drug combination, patients will be seen in the clinic every 3 weeks. These visits will assess the safety and tolerablility of the drug regimen. The drug combination continues until disease progression or unacceptable toxicity. When one of those two events occurs, the patient enters the followup phase. During the followup phase, the patient will return to the clinic every 4 weeks until drug-related toxicities resolve.


Secondary Outcome Measures:
  • The secondary outcome is to evaluate tumor response as a preliminary assessment of clinical activity. [ Time Frame: From start of the study until completion of the drug regimen. This can vary greatly between patients, but on average patients received treatment for 4 cycles (12 weeks). ] [ Designated as safety issue: No ]
    Disease status will be monitored via diagnostic imaging every other cycle (every six weeks) until the patient is finished with drug combination. The drug combination continues until disease progression or unacceptable toxicity.


Enrollment: 19
Study Start Date: July 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily. All participants will receive the study drugs at a baseline dose. If the side effects are minimal and tolerable, the next cycle of study drugs will be given at same dosage. If side effects are intolerable, then the dose will be lowered.
Drug: ixabepilone
by vein once every 3 weeks
Other Name: ixempra
Drug: Dasatinib
by mouth once daily
Other Names:
  • Sprycel
  • BMS-354825

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a solid tumor malignancy that is metastatic or locally advanced/unresectable
  • Progression through standard therapy
  • Histological documentation of cancer
  • Must be off prior chemotherapy or radiation therapy for at least 3 weeks
  • Must have adequate organ and marrow function prior to the start of study treatment as defined by the protocol
  • Must be able to swallow oral medication (dasatinib must be swallowed whole)
  • Must be available for protocol-required follow-up

Exclusion Criteria:

  • Patients with a malignancy (other than the one treated in this study) which required radiotherapy or systemic therapy within the past 5 years
  • Symptomatic brain metastasis that is either untreated or uncontrolled by surgery and or radiotherapy
  • A known, prior, severe (NCI CTC Grade 3/Grade 4) history of hypersensitivity reaction to a drug formulated in Cremophor (polyoxyethylated castor oil)
  • A serious, uncontrolled medical disorder or active infection including pericardial or pleural effusion of any grade,uncontrolled or significant cardiovascular disease,a bleeding disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717704

Locations
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Washington Hospital Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Sandra M Swain, MD Washington Hospital Center
  More Information

No publications provided

Responsible Party: Washington Hospital Center
ClinicalTrials.gov Identifier: NCT00717704     History of Changes
Other Study ID Numbers: WCI-2007-528
Study First Received: July 15, 2008
Last Updated: May 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington Hospital Center:
Malignant solid tumor
Phase 1
Dose escalation
Metastatic or locally advanced/unresectable
Disease progression through standard therapy

Additional relevant MeSH terms:
Neoplasms
Dasatinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014