Back to resultsStudy of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma
Primary Purpose
Any Solid Tumor or Lymphoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
OSI-027
Sponsored by
About this trial
This is an interventional treatment trial for Any Solid Tumor or Lymphoma focused on measuring OSI-027, Solid tumor, Lymphoma
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
Sites / Locations
- Karmanos Cancer Institute
- University Hospitals Leuven
- Royal Mardsen Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Schedule 1
Schedule 2
Schedule 3
Arm Description
Once daily for 3 days every 7 days
Once weekly
Once daily
Outcomes
Primary Outcome Measures
Maximum tolerated dose
Secondary Outcome Measures
Safety profile of OSI-027
Pharmacokinetic profile of OSI-027
Preliminary pharmacodynamic relationship with OSI-027 systemic exposure
Preliminary antitumor activity of OSI-027
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00698243
Brief Title
Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Any Solid Tumor or Lymphoma
Keywords
OSI-027, Solid tumor, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Schedule 1
Arm Type
Experimental
Arm Description
Once daily for 3 days every 7 days
Arm Title
Schedule 2
Arm Type
Experimental
Arm Description
Once weekly
Arm Title
Schedule 3
Arm Type
Experimental
Arm Description
Once daily
Intervention Type
Drug
Intervention Name(s)
OSI-027
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Safety profile of OSI-027
Time Frame
up to 5 years
Title
Pharmacokinetic profile of OSI-027
Time Frame
up to 23 days
Title
Preliminary pharmacodynamic relationship with OSI-027 systemic exposure
Time Frame
up to 23 days
Title
Preliminary antitumor activity of OSI-027
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Royal Mardsen Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
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Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma
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