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

Completed · Phase 1

Conditions studied: Any Solid Tumor or Lymphoma

In brief

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.

Key facts

Study ID

NCT00698243

Run by

Astellas Pharma Inc

People needed

128

Starts

2008-06-01

Expected to finish

2013-02-01

Last updated by the study team

2013-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Karmanos Cancer Institute — Detroit, Michigan, United States
• University Hospitals Leuven — Leuven, Belgium
• Royal Mardsen Hospital — Sutton, Surrey, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.