Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
OSI Pharmaceuticals |
---|---|
Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00513851 |
Open label, phase 1, dose escalation
Condition | Intervention | Phase |
---|---|---|
Advanced Solid Tumors |
Drug: OSI-930 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Dose Escalation Study of Daily Oral OSI-930 in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 60 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Once Daily Dosing
|
Drug: OSI-930
Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity
|
2: Experimental
Twice Daily Dosing
|
Drug: OSI-930
Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, Colorado | |
University of Colorado Cancer Center | |
Aurora, Colorado, United States, 80045 | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United Kingdom, Surrey | |
Cancer Research UK Professor of Medical Oncology | |
Sutton, Surrey, United Kingdom, SM2 5PT |
Study Director: | Andrew Stephens, M.D., PhD | OSI Pharmaceuticals |
Responsible Party: | OSI Pharmaceuticals, Inc. ( Karsten Witt, MD, VP Clinical Development ) |
Study ID Numbers: | OSI-930-102 |
Study First Received: | August 7, 2007 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00513851 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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 |
Ovarian cancer Non-small cell lung cancer Ovarian Neoplasms Renal cancer Kidney cancer Carcinoma, Small Cell Lung Neoplasms Kidney Neoplasms |
Head and Neck Neoplasms Neoplasm Metastasis Carcinoma, Renal Cell Uterine Neoplasms Gastrointestinal Stromal Tumors Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms |