NCT00531284

Phase 1b/2 Study of Carfilzomib in Relapsed Solid Tumors, Multiple Myeloma, or Lymphoma

Phase 1b/2, Multicenter Open-label Study of the Safety and Activity of Carfilzomib in Subjects With Relapsed Solid Tumors, Multiple Myeloma or Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this Phase 1b/2 study were as follows: * Phase 1b (Bolus and Infusion): To evaluate the safety and tolerability of carfilzomib in patients with relapsed solid tumors and in patients with relapsed and/or refractory multiple myeloma and in patients with refractory lymphoma. * Phase 2 (Bolus): To evaluate the overall response rate (ORR) after 4 cycles of carfilzomib in patients with relapsed solid tumors.

Conditions

• Ovarian Cancer
• Renal Cancer
• Non-small Cell Lung Cancer
• Small Cell Lung Cancer
• Solid Tumors
• Multiple Myeloma
• Lymphoma

Interventions

Type	Name	Description
DRUG	Carfilzomib	Administered by intravenous (IV) bolus (2-10 minute) infusion or 30 minute infusion
DRUG	Dexamethasone	Administered orally or by IV infusion prior to carfilzomib

Timeline

• Start date: 2007-09-01
• Primary completion: 2014-10-01
• Completion: 2017-05-22
• First posted: 2007-09-18
• Last updated: 2017-08-15
• Results posted: 2015-12-09

Locations

7 sites across 1 country: United States