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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

Phase 1
18 Years
Not Enrolling
Any Solid Tumor or Lymphoma

Thank you

Trial Information

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

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.

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)≥

- 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

- Hormonal, discontinued prior to registration

- Radiation, minimum of 21 days and recovered from toxic effects prior to

- 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

- Use of drugs causing QT interval prolongation within 14 days prior to dosing

- Patients with clinically significant electrolyte imbalances

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

February 2013

Related Keywords:

  • Any Solid Tumor or Lymphoma
  • OSI-027
  • Solid tumor
  • Lymphoma
  • Lymphoma
  • Neoplasms



Karmanos Cancer Institute Detroit, Michigan  48201