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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00698243
Collaborator
(none)
128
Enrollment
3
Locations
3
Arms
56
Duration (Months)
42.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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 Design

Study Type:
Interventional
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 :
Jun 1, 2008
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose [21 days]

Secondary Outcome Measures

  1. Safety profile of OSI-027 [up to 5 years]

  2. Pharmacokinetic profile of OSI-027 [up to 23 days]

  3. Preliminary pharmacodynamic relationship with OSI-027 systemic exposure [up to 23 days]

  4. Preliminary antitumor activity of OSI-027 [up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karmanos Cancer Institute Detroit Michigan United States 48201
2 University Hospitals Leuven Leuven Belgium 3000
3 Royal Mardsen Hospital Sutton Surrey United Kingdom SM2 5PT

Sponsors and Collaborators

  • Astellas Pharma Inc

Investigators

  • Study Director: Medical Monitor, Astellas Pharma Global Development

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00698243
Other Study ID Numbers:
  • OSI-027-101
  • 2007-006158-25
First Posted:
Jun 17, 2008
Last Update Posted:
Apr 15, 2013
Last Verified:
Apr 1, 2013
Keywords provided by Astellas Pharma Inc
OSI-027
Solid tumor
Lymphoma
Additional relevant MeSH terms:
Lymphoma

Study Results

No Results Posted as of Apr 15, 2013