TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Novartis

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: TKI258

Study type: Interventional

Funder types: Industry

Identifiers

NCT00243763

CTKI258A2103

Details and patient eligibility

About

The primary objective of this study is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of CHIR-258 when administered to subjects with refractory or relapsed multiple myeloma (MM).

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of multiple myeloma
• Evidence of relapsed or refractory disease

Exclusion criteria

• Intracranial disease or epidural disease
• Clinically significant cardiac disease
• Diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)