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A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

Thank you

Trial Information

A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors

Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated
dose on both once daily (QD) and twice daily (BID) schedules.

Patients may continue to receive OSI-930 until one of the following occurs: disease
progression, adverse event requiring withdrawal, failure to recover from toxicity despite a
14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

Inclusion Criteria:

Histologically or cytologically documented malignancy that is now advanced and/or
metastatic and refractory to established forms of therapy or for which no effective
therapy exists.

Age >/= 18 years, ECOG PS 0-2, life expectancy >/= 12 weeks Prior chemotherapy is
permitted provided that a minimum of 3 weeks has elapsed. Prior tyrosine kinase inhibitor
therapy is permitted. Patients must have recovered from any treatment-related toxicities
(with some exceptions) prior to registration.

Prior hormonal therapy is permitted provided it is discontinued prior to registration
(with the exception of prostate cancer patients who have been on hormone therapy for at
least 3 months).

Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow
reserve and patients have recovered from the toxic effects. A minimum of 21 days must
have elapsed unless the radiotherapy was palliative and nonmyelosuppressive.

ANC >/= 1.5 x 10^9/L, PLT >/= 100 x 10^9/L; bilirubin (ULN), AST and ALT follow-up. Patients must practice effective contraceptive measures throughout the study.
Provide written informed consent.

Exclusion Criteria:

Symptomatic brain metastases which are not stable, require steroids, are potentially
life-threatening or that have required radiation within the last 28 days.

History of allergic reaction attributed to a similar compound as study drug. Significant
cardiac disease unless well controlled, poorly controlled hypertension.

Active or uncontrolled infections of serious illnesses or medical conditions that could
interfere with participation.

History of any psychiatric condition that might impair the patient's ability to provide
informed consent or participate.

Concurrent anticancer therapy. Use of CYP3A4 inducers/inhibitors during the 14 days prior
to first dose. Pregnant or breast-feeding females.

Type of Study:


Study Design:

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

Outcome Measure:

Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of OSI-930

Outcome Time Frame:

2.5 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

September 2009

Related Keywords:

  • Advanced Solid Tumors
  • Advanced Cancer
  • Non-small cell lung cancer
  • Small cell lung cancer
  • Uterine cancer
  • Ovarian cancer
  • Renal cancer
  • Head and neck cancer
  • Cervical cancer
  • Metastatic cancer
  • Colorectal cancer
  • Gastrointestinal stromal tumors



University of Colorado Cancer CenterDenver, Colorado  80262
Dana-Farber Cancer InstituteBoston, Massachusetts  02115