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Phase 1 Study of Intermittent OSI-906 Dosing

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

Sponsored by: OSI Pharmaceuticals
Information provided by: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00514306
  Purpose

Multicenter, open-label, phase 1, cohort dose escalation study to determine the MTD of 3 intermittent dosing 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 Intermittent 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 each of 3 intermittent 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:   75
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
Schedule 1 (OSI-906 days 1-3 every 14 days)
Drug: OSI-906
Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
2: Experimental
Schedule 2 (OSI-906 days 1-5 every 14 days)
Drug: OSI-906
Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity
3: Experimental
Schedule 3 (OSI-906 days 1-7 every 14 days)
Drug: OSI-906
Oral OSI-906 administered on an intermittent schedule at increasing doses until disease progression or unacceptable toxicity

Detailed Description:

Multicenter, open-label, phase 1, cohort dose escalation. The study will open with S1 (OSI-906 QD Days 1-3 every 14 days). S2 (OSI-906 QD Days 1-5 every 14 days) will be initiated following observation of clinically significant related toxicity >/= grade 2 in S1 or after a review of preliminary safety and PK data from >/= 6 dose levels in S1 indicate that toxicity is acceptable and potential improvement in exposure may be achieved by an increased number of dosing days. S3 (OSI-906 QD Days 1-7 every 14 days) will occur upon observation of clinically significant related toxicity >/= grade 2 in S2 or after >/= 1 dose level in S2 has been examined. In each schedule, a single dose will be administered on each of the specified days followed by a drug-free period through to Day 14. A treatment period is defined as 14 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.
  • History of allergic reaction attributed to a similar compound as study drug.
  • 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
  • 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
  • History of any kind of stroke.
  • History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate.
  • Accessible for repeat dosing and follow-up, including pharmacokinetic sampling.
  • Patients must practice effective contraceptive measures throughout the study.
  • Provide written informed consent.
  • 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

Exclusion Criteria:

  • Any type of active seizure disorder.
  • Concurrent anticancer 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.
  • Previously diagnosed brain metastases.
  • Documented history of diabetes mellitus.
  • Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation.
  • Pregnant or breast-feeding females.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514306

Contacts
Contact: OSIP Medical Informaiton     800.572.1932 ext 7821     medical-information@osip.com    

Locations
United States, Texas
MD Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Contact: OSIP Medical Informaiton     800-572-1932 ext 7821     medical-information@osip.com    
United Kingdom, Surrey
Cancer Research UK Professor of Medical Oncology     Recruiting
      Sutton, Surrey, United Kingdom, SM2 5PT
      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, VIP Clinical Development )
Study ID Numbers:   OSI-906-102
First Received:   August 7, 2007
Last Updated:   October 2, 2008
ClinicalTrials.gov Identifier:   NCT00514306
Health Authority:   United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

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