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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00698243
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : April 15, 2013
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Any Solid Tumor or Lymphoma Drug: OSI-027 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Schedule 1
Once daily for 3 days every 7 days
Drug: OSI-027
Administered orally
Experimental: Schedule 2
Once weekly
Drug: OSI-027
Administered orally
Experimental: Schedule 3
Once daily
Drug: OSI-027
Administered orally

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Safety profile of OSI-027 [ Time Frame: up to 5 years ]
  2. Pharmacokinetic profile of OSI-027 [ Time Frame: up to 23 days ]
  3. Preliminary pharmacodynamic relationship with OSI-027 systemic exposure [ Time Frame: up to 23 days ]
  4. Preliminary antitumor activity of OSI-027 [ Time Frame: up to 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00698243

United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
University Hospitals Leuven
Leuven, Belgium, 3000
United Kingdom
Royal Mardsen Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Medical Monitor Astellas Pharma Global Development

Responsible Party: Astellas Pharma Inc Identifier: NCT00698243     History of Changes
Other Study ID Numbers: OSI-027-101
2007-006158-25 ( EudraCT Number )
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

Keywords provided by Astellas Pharma Inc:
Solid tumor

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases