Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma | Completed
Study of Oral OSI-027 in Patients With Advanced Solid Tumors or Lymphoma
Health Conditions
  • Any Solid Tumor or Lymphoma
Completed
Recruitment Status
NCT00698243
Primary Trial ID Number
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.
Primary Outcome Measures
  • Maximum tolerated dose; 21 days
Secondary Outcome Measures
  • Safety profile of OSI-027; up to 5 years; Pharmacokinetic profile of OSI-027; up to 23 days; Preliminary pharmacodynamic relationship with OSI-027 systemic exposure; up to 23 days; Preliminary antitumor activity of OSI-027; up to 5 years
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United States; Belgium; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion 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
Interventions
Drug; OSI-027; Administered orally; [Schedule 1, Schedule 2, Schedule 3]
Design Details
Sorry, this information is not available
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific 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
Secondary Trial Identifying Number
2007-006158-25
Website
Sorry, this information is not available
Study Funded By
Astellas Pharma Inc
Funder Type
Sorry, this information is not available
Study Sponsored By
Astellas Pharma Inc
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

13 Jun 2008

Last Updated

11 Apr 2013

Date Record Refreshed on UKCTG

31 Jul 2015