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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00698243
First received: June 13, 2008
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Any Solid Tumor or Lymphoma
Drug: OSI-027
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety profile of OSI-027 [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile of OSI-027 [ Time Frame: up to 23 days ] [ Designated as safety issue: No ]
  • Preliminary pharmacodynamic relationship with OSI-027 systemic exposure [ Time Frame: up to 23 days ] [ Designated as safety issue: No ]
  • Preliminary antitumor activity of OSI-027 [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: June 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698243

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00698243     History of Changes
Other Study ID Numbers: OSI-027-101, 2007-006158-25
Study First Received: June 13, 2008
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Astellas Pharma Inc:
OSI-027
Solid tumor
Lymphoma

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

ClinicalTrials.gov processed this record on August 01, 2014