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Study Evaluating SKI-606 in Subject With Solid Tumors

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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

NCT01001936
Pfizer
Completed
Study Evaluating SKI-606 in Subject With Solid Tumors

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Study Evaluating SKI-606 in Subject With Solid Tumors
Phase 1 Does-escalation Study of Oral SKI-606 in Subjects With Advanced Malignant Solid Tumors
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tumors
Drug: SKI-606
Experimental: 1
Intervention: Drug: SKI-606
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2008
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01001936
3160A1-102
Yes
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
October 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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