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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 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
  • 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
Study First Received: August 7, 2007
Last Updated: December 22, 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 January 16, 2009