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Study Evaluating SKI-606 in Subject With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT01001936
First received: October 26, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

The purpose of this study is to evaluate the safety and tolerability of oral SKI-606 (100, 200, 300 or 400 mg) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population. This study will also obtain preliminary information on the pharmacokinetics and antitumor activity of orally administered SKI-606 in subjects with advanced malignant solid tumors


Condition Intervention Phase
Tumors
 Drug: SKI-606
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Bosutinib
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety as measured by AE information. Tolerability as measured by DLT observation. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics as measured by Taylor Technology Antitumor activity as measured by RECIST [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: February 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SKI-606

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available
  2. Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding alopecia)
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  4. Adequate hepatic, renal, and bone marrow function
  5. Age 20 to 74 years
  6. Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control for the duration of the study and for 6 months and 30 days after the last dose of test article for male and female, respectively
  7. Life expectancy of at least 12 weeks

Exclusion Criteria:

  1. Use of any systemic antitumor agents or any investigational agent within 28 days before the enrollment (42 days if the previous chemotherapy included nitrosoureas or mitomycin C)
  2. Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4
  3. Prior exposure to SKI-606 or any other Src-kinase inhibitor
  4. Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from previous surgery should be complete before day 1)
  5. Subjects unable or unwilling to swallow SKI-606 capsules
  6. Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth
  7. Recent or ongoing clinically-significant gastrointestinal disorder
  8. Pregnant or breastfeeding women

  9. Subjects who meet the following criteria:

    • Evidence of serious active infection, significant medical or psychiatric illness
    • History of unexplained syncope or known ventricular arrythmia
    • Known seropositivity to HIV, or current or chronic Hepatitis B or Hepatitis hepatitis C
    • Hypokalemia
    • Unstable concurrent medical conditions
    • Any other condition that, in the investigator's judgment, make the subject inappropriate for this study the subject inappropriate for this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001936

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT01001936     History of Changes
Other Study ID Numbers: 3160A1-102
Study First Received: October 26, 2009
Last Updated: October 26, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
PHASE 1 SKI-606 Solid tumor

ClinicalTrials.gov processed this record on June 17, 2013