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A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

Thank you

Trial Information

A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced Solid Tumors

Multicenter, open-label, phase 1, cohort dose escalation. The study will open with the QD
schedule, with initiation of the BID schedule occurring after observation of clinically
significant related toxicity ≥ grade 2 in the QD schedule.

Dosing will be initiated on Day 1 with daily dosing (either QD or BID) continuing for 21

Once the recommended phase 2 dose has been determined for the BID schedule, 2 expansion
cohorts will be opened: 1) Biomarker Expansion Cohort in patients with locally advanced or
metastatic colorectal cancer and 2) Diabetic Expansion Cohort in patients with advanced
solid tumors who have active Type 2 diabetes mellitus not requiring insulin or
insulinotropic therapy.

This study is currently only recruiting to the Biomarker and Diabetic Expansion Cohorts.

Inclusion Criteria:

- Histologically or cytologically documented malignancy that is now advanced and/or
metastatic and refractory to established forms of therapy or for which no effective
therapy exists. Patients in the Biomarker Expansion Cohort must have histologically
documented colorectal cancer that is locally advanced or metastatic and refractory to
established forms of therapy. These patients must have archival tissue available and
a lesion accessible for biopsy

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2, life
expectancy ≥ 12 weeks

- Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed.
Prior tyrosine kinase inhibitor therapy is permitted. Patients must have recovered
from any treatment-related toxicities (with some exceptions) prior to registration

- Prior hormonal therapy is permitted provided it is discontinued prior to registration
(with the exception of prostate cancer patients who have been on hormone therapy for
at least 3 months)

- Prior radiation therapy is permitted provided that patients have recovered from the
toxic effects. A minimum of 21 days must have elapsed unless the radiotherapy was
palliative and nonmyelosuppressive

- Prior surgery is permitted provided that wound healing has occurred prior to

- Fasting glucose ≤ 125 mg/dL (7 mmol/L) at baseline (all patients except those in the
Diabetic Expansion Cohort). Patients in the Diabetic Expansion Cohort must have a
fasting glucose of ≤ 150 mg/dL (8.3 mmol/L) at baseline. If patients in the Diabetic
Expansion Cohort are being treated with non-insulinotropic oral antihyperglycemic
therapy, doses must be stable for ≥ 4 weeks prior to registration

- Potassium, calcium, and magnesium must be within normal limits (WNL). Electrolyte
abnormalities will be permitted if they are not clinically significant and if
treatment for the abnormality is initiated prior to Day 1

- Neutrophil ≥ 1.5 x 10^9/L, Platelet (PLT) ≥ 100 x 10^9/L; bilirubin ≤ 1.5 x upper
limit of normal (ULN), AST and ALT ≤ 2.5 x ULN or ≤ 5 x UNL if patient has documented
liver metastases; creatinine ≤ 1.5 x ULN

- Accessible for repeat dosing and follow-up, including pharmacokinetic sampling

- Patients must practice effective contraceptive measures throughout the study

- Provide written informed consent

Exclusion Criteria:

- History of any kind of stroke

- History of any psychiatric condition that might impair the patient's ability to
provide informed consent or participate

- History of allergic reaction attributed to a similar compound as study drug.

- Any type of active seizure disorder

- Previously diagnosed brain metastases

- Concurrent anticancer therapy

- Active or uncontrolled infections of serious illnesses or medical conditions that
could interfere with participation

- Pregnant or breast-feeding females

- Documented history of diabetes mellitus (all patients except those in the Diabetic
Expansion Cohort). Patients in the Diabetic Expansion Cohort may not have Type 1
diabetes mellitus or Type 2 diabetes mellitus currently requiring insulinotropic or
insulin therapy

- Use of drugs with a risk of causing QT interval prolongation within 14 days prior to
Day 1 and while on study

- Use of glucocorticoids within 14 days prior to Day 1 and while on study

- History of significant cardiac disease unless well controlled (includes 2nd/3rd
degree heart block, ischemic heart disease, QTc > 450 msec, poorly controlled
hypertension, or congestive heart failure of New York Heart Association (NYHA) Class
II or worse)

Type of Study:


Study Design:

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

Outcome Measure:

Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of oral OSI-906

Outcome Time Frame:

21 days

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

March 2012

Related Keywords:

  • Advanced Solid Tumors
  • Non-small cell lung cancer
  • Ovarian cancer
  • Renal cancer
  • Advanced Cancer
  • Metastatic cancer
  • Breast cancer
  • Colorectal cancer



Vanderbilt Universtiy Medical CenterNashville, Tennessee  37232-6307