Expired Study
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Detroit, Michigan 48201


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT00698243


Primary Contact:

Study Director
Medical Monitor
Astellas Pharma Global Development


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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