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

NCT ID: NCT00698243

Last Updated: 2013-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-02-28

Brief 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.

Detailed Description

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.

Conditions

Any Solid Tumor or Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Schedule 1

Once daily for 3 days every 7 days

Group Type: EXPERIMENTAL

OSI-027

Intervention Type: DRUG

Administered orally

Schedule 2

Once weekly

Group Type: EXPERIMENTAL

OSI-027

Intervention Type: DRUG

Administered orally

Schedule 3

Once daily

Group Type: EXPERIMENTAL

OSI-027

Intervention Type: DRUG

Administered orally

Interventions

OSI-027

Administered orally

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Karmanos Cancer Institute

Detroit, Michigan, United States

University Hospitals Leuven

Leuven, , Belgium

Royal Mardsen Hospital

Sutton, Surrey, United Kingdom

Countries

United States; Belgium; United Kingdom

Other Identifiers

2007-006158-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OSI-027-101

Identifier Type: -

Identifier Source: org_study_id