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Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information


Inclusion Criteria:



- Advanced cancer for which there is no treatment available which would have a
reasonable chance of disease palliation or cure

- Age greater than or equal to 18.

- SWOG performance Status less than or equal to 2.

- Meets protocol requirements for specified laboratory values.

- Written informed consent and cooperation of patient.

Exclusion Criteria:

- Prior treatment with an FPTI

- Knowledge of intracranial metastases or carcinomatous meningitis.

- Poor medical risks because of nonmalignant systemic disease or uncontrolled active
infection.

- Medical conditions that would interfere with taking oral medications.

- Significant uncontrolled diarrhea.

- Chemotherapy, radiotherapy or major surgery within 4 weeks; full recovery from prior
treatment.

- Concomitant use of CYP3A inhibitors/inducers per protocol.

- Known HIV positivity or AIDS-related illness.

- Pregnant or nursing women.

- Men or women of childbearing potential who are not using an effective method of
contraception.

- Concurrent chemotherapy, hormonal therapy, radiotherapy or immunotherapy.

- QTc prolongation (>440 msecs) at baseline.

- Patients with previous high-dose therapy requiring stem cell rescue or bone marrow
transplant, or irradiation to >30% of bone marrow-containing areas.

- Patients that have received Mitomycin-C or nitrosoureas.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

P01499

NCT ID:

NCT00040534

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Neoplasms
  • Advanced Cancer
  • Neoplasms

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