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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Description:

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.

Outcome 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).

Safety Issue:

Yes

Principal Investigator

Sandra M Swain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington Hospital Center

Authority:

United States: Food and Drug Administration

Study ID:

WCI-2007-528

NCT ID:

NCT00717704

Start Date:

July 2008

Completion Date:

May 2011

Related Keywords:

  • Solid Tumor
  • Malignant solid tumor
  • Phase 1
  • Dose escalation
  • Metastatic or locally advanced/unresectable
  • Disease progression through standard therapy
  • Neoplasms

Name

Location
Washington Cancer Institute Washington, District of Columbia  20010