Clinical trial NCT00513851: Phase 1 Study of OSI-930 in Cancer Patients
Official title: A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: 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
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: OSI Pharmaceuticals
First posted: 2007-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open label, phase 1, dose escalation

Detailed description: 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.

Eligibility criteria: 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 \</= 1.5 x upper limit of normal (ULN), AST and ALT \</= 2.5 x ULN; creatinine \</= 1.5 ULN Accessible for repeat dosing and 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.

Primary outcomes:
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
timeFrame: 2.5 years
Secondary outcomes:
measure: Safety, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Sutton
country: United Kingdom
facility: Cancer Research UK Professor of Medical Oncology
state: Surrey
Study officials:
References: