Status:
COMPLETED
Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Any Solid Tumor or Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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, intermitte...
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 significa...
Eligibility Criteria
Inclusion
- Histologically or cytologically documented malignancy (solid tumor or lymphoma)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- Predicted life expectancy of at least 3 months
- Adequate hematopoietic and hepatic function, and normal renal function
- Fasting glucose \<7mmol/L at baseline
- Left ventricular ejection fracture (LVEF) by Multiple gated acquisition scan (MUGA)≥ 60%
- Practice effective contraceptive measures throughout study
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00698243
Start Date
June 1 2008
End Date
February 1 2013
Last Update
April 15 2013
Active Locations (3)
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1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
2
University Hospitals Leuven
Leuven, Belgium, 3000
3
Royal Mardsen Hospital
Sutton, Surrey, United Kingdom, SM2 5PT