Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc

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