A Phase 1 interventional study of OSI-930 and OSI-930 in Advanced Solid Tumors, sponsored by Astellas Pharma Inc. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-27.
Sponsored by Astellas Pharma Inc · Phase 1, Interventional, and Treatment
Open label, phase 1, dose escalation
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.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Once Daily Dosing
Drug: OSI-930
Twice Daily Dosing
Drug: OSI-930
Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity
Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity
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
Time frame: 2.5 years
Safety, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity
Time frame: 2.5 years
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →