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Phase 1 Study of Continuous OSI-906 Dosing

This study is currently recruiting participants.
Verified by OSI Pharmaceuticals, June 2008

Sponsored by: OSI Pharmaceuticals
Information provided by: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00514007
  Purpose

Multicenter, open-label, phase 1, cohort dose escalation study to determine the MTD on both QD and BID schedules.


Condition Intervention Phase
Advanced Solid Tumors
Drug: OSI-906
Phase I

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   A Phase I Dose Escalation Study of Continuous Oral OSI-906 Dosing in Patients With Advanced Solid Tumors

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Safety profile, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   60
Study Start Date:   December 2006
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   June 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Once per day
Drug: OSI-906
Oral OSI-906 administered once daily at increasing doses until disease progression or unacceptable toxicity
2: Experimental
Twice per day
Drug: OSI-906
Oral OSI-906 administered twice daily at increasing doses until disease progression or unacceptable toxicity

Detailed Description:

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.

  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 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 within normal limits (WNL) for every measurement within 7 days of 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514007

Contacts
Contact: OSIP Medical Informaiton     800.572.1932, x7821     medical-information@osip.com    

Locations
United States, Tennessee
Vanderbilt Universtiy Medical Center     Recruiting
      Nashville, Tennessee, United States, 37232-6307
      Contact: OSIP Medical Informaiton     800-572-1932 ext 7821     medical-information@osip.com    
United Kingdom
The Beatson West of Scotland Cancer Centre     Recruiting
      Glasgow, United Kingdom, G12 0YN
      Contact: OSIP Medical Informaiton     800.572.1932 ext 7821     medical-information@osip.com    

Sponsors and Collaborators
OSI Pharmaceuticals

Investigators
Study Director:     Andrew Stephens, M.D., PhD     OSI Pharmaceuticals    
  More Information


Responsible Party:   OSI Pharmaceuticals ( Karsten Witt, MD, VP Clinical Development )
Study ID Numbers:   OSI-906-101
First Received:   August 7, 2007
Last Updated:   June 13, 2008
ClinicalTrials.gov Identifier:   NCT00514007
Health Authority:   United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by OSI Pharmaceuticals:
Non-small cell lung cancer  
Ovarian cancer  
Renal cancer  
Advanced Cancer  
Metastatic cancer
Breast cancer
Colorectal cancer

Study placed in the following topic categories:
Ovarian cancer
Non-small cell lung cancer
Ovarian Neoplasms
Kidney Neoplasms
Lung Neoplasms
Carcinoma, Renal Cell
Neoplasm Metastasis
Breast Neoplasms
Renal cancer
Kidney cancer
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms

ClinicalTrials.gov processed this record on December 03, 2008




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