TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

• Sponsor: Novartis (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00243763
• Collaborator: (none)
• Enrollment: 64
• Locations: 5
• Patients Per Site: 12.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: TKI258	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1 Dose Escalating Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TKI258 in Subjects With Refractory or Relapsed Multiple Myeloma

Outcome Measures

Primary Outcome Measures

1. Maximum tolerated dose []

2. Dose limiting toxicity []

3. Safety profile []

Secondary Outcome Measures

1. Evaluation of pharmacokinetics and pharmacodynamics []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic - Arizona	Scottsdale	Arizona	United States	85259
2	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
3	Emory University	Atlanta	Georgia	United States	30322
4	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
5	Mayo Clinic - Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00243763
• Other Study ID Numbers: CTKI258A2103
• First Posted: Oct 25, 2005
• Last Update Posted: Nov 23, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: Refractory Multiple Myeloma or; Relapsed Multiple Myeloma
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Nov 23, 2009