An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Gimatecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441610

CLBQ707A1101E1

Details and patient eligibility

About

CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.

Enrollment: 4 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients completing the core protocol (CLBQ707A1101, NCT00410358) exhibiting stable disease, or a partial or complete response as defined by the core protocol. If patients only have non-measurable lesions, he/she must not be exhibiting progressive disease

Exclusion criteria

• Documented progressive disease as defined by the core protocol
• Patients with performance status of 3 or 4 on the ECOG scale

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Gimatecan

Experimental group

Treatment:

Drug: Gimatecan