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Completed

NCT Number: NCT00717704

Solid Tumors Using Ixabepilone and Dasatinib

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.

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Key information

Conditions

Solid Tumor Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ixabepilone

Drug

by vein once every 3 weeks

Other names: ixempra

dasatinib

Drug

by mouth once daily

Other names: Sprycel, BMS-354825

Primary outcomes

  1. 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).

    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 outcomes

  1. 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).

    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.

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Phase I Study of Ixabepilone Combined With Dasatinib in Patients With Solid Tumors

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 17, 2008
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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