Study Evaluating SKI-606 in Subject With Solid Tumors

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NCT01001936

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-74 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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TumorsStudy Evaluating SKI-606 in Subject With Solid Tumors NCT01001936
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating SKI-606 in Subject With Solid Tumors
Official Title  ICMJE Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tumors
Intervention  ICMJE Drug: SKI-606
Study Arms  ICMJE Experimental: 1
Intervention: Drug: SKI-606
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2009)		28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01001936
Other Study ID Numbers  ICMJE 3160A1-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP