Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

Novartis

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: gimatecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420485

CLBQ707A2101

Details and patient eligibility

About

This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced or metastatic cancer
• 18 years and above

Exclusion criteria

• Previous treatment with 4 or more cycles of carboplatin;
• Previous treatment with 2 or more courses of nitrosourea or mitomycin;
• Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
• Severe and/or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Daily times five schedule

Experimental group

Treatment:

Drug: gimatecan

Continuous schedule, twice daily

Experimental group

Treatment:

Drug: gimatecan