CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 184 enrolled
Drug / intervention
Carfilzomib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00531284
NCT00531284Phase 2Completed
CompareCT.gov

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

Amgen·interventional·Posted Sep 18, 2007·Updated Aug 15, 2017

In Brief

A Phase 2 clinical trial evaluating Carfilzomib and Dexamethasone for Ovarian Cancer and 6 related conditions. Completed, enrolled 184 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Renal Cancer, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Solid Tumors, Multiple Myeloma, Lymphoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 18, 2007
Enrollment StartSep 1, 2007
Primary CompletionOct 1, 2014
Study CompletionMay 22, 2017
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 18.8 years ago

Interventions

Carfilzomibdrug

Administered by intravenous (IV) bolus (2-10 minute) infusion or 30 minute infusion

Dexamethasonedrug

Administered orally or by IV infusion prior to carfilzomib