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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

July 15, 2008
May 29, 2012
July 2008
May 2011   (final data collection date for primary outcome measure)
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.
The primary outcome is dichotomous - either induced dose limiting toxicity or not [ Time Frame: review prior to each dose escalation ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00717704 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Solid Tumors Using Ixabepilone and Dasatinib
A Phase I Study of Ixabepilone Combined With Dasatinib in Patients With Solid Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor
  • Drug: ixabepilone
    by vein once every 3 weeks
    Other Name: ixempra
  • Drug: Dasatinib
    by mouth once daily
    Other Names:
    • Sprycel
    • BMS-354825
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.
Interventions:
  • Drug: ixabepilone
  • Drug: Dasatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717704
WCI-2007-528
Yes
Washington Hospital Center
Washington Hospital Center
Bristol-Myers Squibb
Principal Investigator: Sandra M Swain, MD Washington Hospital Center
Washington Hospital Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP