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Study Evaluating SKI-606 in Subject With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01001936
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : October 27, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Tumors Drug: SKI-606 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors
Study Start Date : February 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bosutinib

Arm Intervention/treatment
Experimental: 1 Drug: SKI-606

Primary Outcome Measures :
  1. Safety as measured by AE information. Tolerability as measured by DLT observation. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Pharmacokinetics as measured by Taylor Technology Antitumor activity as measured by RECIST [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01001936

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT01001936    
Other Study ID Numbers: 3160A1-102
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
PHASE 1 SKI-606 Solid tumor
Additional relevant MeSH terms:
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