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

Launched by ASTELLAS PHARMA INC · Jun 16, 2008

Keywords

ClinConnect 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.

Gender

ALL

Eligibility 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