Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: bosutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195260

B1871012

3160A1-100

Details and patient eligibility

About

To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
• Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Other inclusion applies.

Exclusion criteria

• Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered.
• Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1).
• Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for >= 2 weeks before day 1).
• Other exclusion applies.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 4 patient groups

Dose escalation

Experimental group

Description:

Dose finding study of monotherapy bosutinib in patients with advanced solid tumors.

Treatment:

Drug: bosutinib

Drug: bosutinib

Drug: bosutinib

Drug: bosutinib

Colorectal Cancer

Experimental group

Description:

Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.

Treatment:

Drug: bosutinib

Drug: bosutinib

Drug: bosutinib

Drug: bosutinib

Pancreatic Cancer

Experimental group

Description:

Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.

Treatment:

Drug: bosutinib

Drug: bosutinib

Drug: bosutinib

Drug: bosutinib

Non-Small Cell Lung Cancer (NSCLC)

Experimental group

Description:

Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.

Treatment:

Drug: bosutinib

Drug: bosutinib

Drug: bosutinib

Drug: bosutinib