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Phase 1 Study of Continuous OSI-906 Dosing
This study is currently recruiting participants.
Study NCT00514007   Information provided by OSI Pharmaceuticals
First Received: August 7, 2007   Last Updated: August 3, 2009   History of Changes

August 7, 2007
August 3, 2009
December 2006
December 2009   (final data collection date for primary 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 OSI-906 [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00514007 on ClinicalTrials.gov Archive Site
Safety profile, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
Same as current
 
Phase 1 Study of Continuous OSI-906 Dosing
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 study to determine the MTD on both QD and BID schedules.

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 days.

Patients may continue to receive OSI-906 until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Advanced Solid Tumors
Drug: OSI-906
  • Experimental: Once per day
  • Experimental: Twice per day
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
March 2010
December 2009   (final data collection date for primary outcome measure)

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.
  • Age >/= 18 years, ECOG 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.
  • Fasting glucose </= 125 mg/dL (7 mmol/L) at baseline
  • 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.
  • ANC >/= 1.5 x 10^9/L, PLT >/= 100 x 10^9/L; bilirubin </= 1.5 x upper limit of normal (ULN), AST and ALT </= 2.5 x ULN; creatinine </= 1.5 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.
  • 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, and congestive heart failure of New York Heart Association (NYHA) Class II or worse
Both
18 Years and older
No
Contact: OSIP Medical Information 800.572.1932, x7821 medical-information@osip.com
United States,   United Kingdom
 
NCT00514007
Karsten Witt, MD, VP Clinical Development, OSI Pharmaceuticals
OSI-906-101
OSI Pharmaceuticals
 
Study Director: Andrew Stephens, M.D., PhD OSI Pharmaceuticals
OSI Pharmaceuticals
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP