Any Solid Tumor or Lymphoma Clinical Trial
Official title:
A Phase 1 Dose-escalation Study of Intermittent, Once Weekly, and Continuous Daily Oral OSI-027 Dosing in Patients With Advanced Solid Tumors or Lymphoma
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.
| Status | Completed |
| Enrollment | 128 |
| Est. completion date | February 2013 |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospitals Leuven | Leuven | |
| United Kingdom | Royal Mardsen Hospital | Sutton | Surrey |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
United States, Belgium, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum tolerated dose | 21 days | Yes | |
| Secondary | Safety profile of OSI-027 | up to 5 years | Yes | |
| Secondary | Pharmacokinetic profile of OSI-027 | up to 23 days | No | |
| Secondary | Preliminary pharmacodynamic relationship with OSI-027 systemic exposure | up to 23 days | No | |
| Secondary | Preliminary antitumor activity of OSI-027 | up to 5 years | No |