Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma
- Registration Number
- NCT00698243
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and to establish the recommended phase 2 dose of oral OSI-027 when administered via 3 schedules, namely, intermittent, weekly, and continuous in patients with advanced solid tumors or lymphoma, namely, intermittent, weekly, and continuous.
- Detailed Description
The study will open with Schedule 1 (S1, intermittent) with initiation of Schedule 2 (S2, weekly) and Schedule 3 (S3, continuous), which may occur in parallel after observation of clinically significant related dose limiting toxicity (DLT) in the S1 schedule. Dosing will be initiated on Day 1 with intermittent weekly dosing continuing for 21 days (1 Treatment Period). Expansion of Dose Escalation Cohorts may occur for S1 and S2 at the recommended phase 2 dose level(s) and a Biomarker Expansion Cohort may be opened in S1 and/or S2.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
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Histologically or cytologically documented malignancy (solid tumor or lymphoma)
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Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
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Predicted life expectancy of at least 3 months
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Adequate hematopoietic and hepatic function, and normal renal function
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Fasting glucose <7mmol/L at baseline
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Left ventricular ejection fracture (LVEF) by Multiple gated acquisition scan (MUGA)≥ 60%
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Practice effective contraceptive measures throughout study
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Verbal and written informed consent
-
Prior therapy:
- Chemotherapy, minimum of 3 weeks and recovered from any treatment-related toxicities (except for alopecia, and grade 1 neurotoxicity) prior to registration
- Hormonal, discontinued prior to registration
- Radiation, minimum of 21 days and recovered from toxic effects prior to registration
- Surgery, provided wound healing has occurred
- History of significant cardiac disease unless well controlled
- Discontinuation from prior therapy due to cardiac toxicity
- Active or uncontrolled infections
- Serious illness or medical condition that could interfere with study participation
- History of any psychiatric condition that might impair understanding or compliance
- Documented history of diabetes mellitus
- Pregnant or breastfeeding females
- Unstable symptomatic brain metastases, that require steroid or that have required radiation in the last 28 days
- Chronic systemic steroid use for cancer related condition
- History of allergic reactions
- Patients with cataract who are expected to undergo surgery within 6 months of registration
- Use of drugs causing QT interval prolongation within 14 days prior to dosing
- Patients with clinically significant electrolyte imbalances
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Schedule 1 OSI-027 Once daily for 3 days every 7 days Schedule 2 OSI-027 Once weekly Schedule 3 OSI-027 Once daily
- Primary Outcome Measures
Name Time Method Maximum tolerated dose 21 days
- Secondary Outcome Measures
Name Time Method Safety profile of OSI-027 up to 5 years Pharmacokinetic profile of OSI-027 up to 23 days Preliminary pharmacodynamic relationship with OSI-027 systemic exposure up to 23 days Preliminary antitumor activity of OSI-027 up to 5 years
Trial Locations
- Locations (3)
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University Hospitals Leuven
🇧🇪Leuven, Belgium
Royal Mardsen Hospital
🇬🇧Sutton, Surrey, United Kingdom