Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00243763
NCT00243763
Terminated
Phase 1

Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Novartis5 sites in 1 country64 target enrollmentOctober 25, 2005
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsMultiple Myeloma
DrugsTKI258

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Multiple Myeloma
Sponsor
Novartis
Enrollment
64
Locations
5
Primary Endpoint
Maximum tolerated dose
Status
Terminated
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
October 25, 2005
End Date
TBD
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Novartis

Eligibility Criteria

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

Outcomes

Primary Outcomes

Maximum tolerated dose

Dose limiting toxicity

Safety profile

Secondary Outcomes

  • Evaluation of pharmacokinetics and pharmacodynamics

Study Sites (5)

Loading locations...

Similar Trials

Terminated
Phase 1
Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid LeukemiaAcute Myeloid Leukemia
NCT00279773Novartis Pharmaceuticals34
Completed
Phase 1
A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic CarcinomaNeoplasms, Liver
NCT00629759Jennerex Biotherapeutics14
Completed
Phase 1
A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.Refractory or Recurrent CD30+ Hematologic Malignancies
NCT03894150Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.45
Completed
Phase 1
Safety Study of Sterile Compound C31510 for Injection to Subjects with Solid TumorsSolid Tumors
NCT01251562BPGbio50
Completed
Phase 1
Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573Neoplasms
NCT02405065Hanmi Pharmaceutical Company Limited72