Study Evaluating SKI-606 in Subject With Solid Tumors

NCT01001936 | Completed Phase 1 DMC

• 1 other identifier: 3160A1-102
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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

Conditions

Tumors

Keywords

PHASE 1 SKI-606 Solid tumor

Outcome Measures

Primary Outcomes (1)

• Safety as measured by AE information. Tolerability as measured by DLT observation.

  2 years

Secondary Outcomes (1)

• Pharmacokinetics as measured by Taylor Technology Antitumor activity as measured by RECIST

  2 years

Study Arms (1)

1

EXPERIMENTAL

Drug: SKI-606

Interventions

SKI-606 DRUG

1

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available
• Recovery from acute adverse effects of prior therapies to £ Grade 1 (excluding alopecia)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
• Adequate hepatic, renal, and bone marrow function
• Age 20 to 74 years
• 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
• Life expectancy of at least 12 weeks

You may not qualify if:

• 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)
• Ongoing clinical requirement for administration of a strong inhibitor of CYP3A4
• Prior exposure to SKI-606 or any other Src-kinase inhibitor
• Major surgery or radiotherapy within 2 weeks before the enrollment (recovery from previous surgery should be complete before day 1)
• Subjects unable or unwilling to swallow SKI-606 capsules
• Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth
• Recent or ongoing clinically-significant gastrointestinal disorder
• Pregnant or breastfeeding women
• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Conditions

Neoplasms

Interventions

bosutinib

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: February 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 27, 2009

Record last verified: 2009-10