A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00884312
• Date of registration: 16/04/2009
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
• Scientific title: An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
• Date of first enrolment: April 9, 2009
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00884312
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Previous completion of a carfilzomib study within 90 days prior to first dose of
maintenance study drug.

2. Disease Assessments performed within 30 days prior to first dose of maintenance study
drug.

3. Written informed consent in accordance with federal, local, and institutional
guidelines

4. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test, with a sensitivity of at least 50 mIU/mL, within 3 days prior to first dose of
maintenance study drug.

5. Subjects must agree to adhere to the study visit schedule and other study requirements
and receive outpatient treatment and laboratory monitoring at the institution that
administers the drug.

Exclusion Criteria:

1. Administration of an intervening chemotherapy between the time of previous carfilzomib
study termination and first dose of maintenance study drug.

2. Pregnant or lactating females

3. Diagnosis of a new malignancy of a different tumor type.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Solid Tumors

Intervention(s)

Drug: Carfilzomib

Primary Outcome(s)

Number of Participants With Peripheral Neuropathy [Time Frame: From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.]

Number of Participants With Adverse Events [Time Frame: From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.]

Secondary Outcome(s)

Progression-free Survival [Time Frame: From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.]

Time to Progression [Time Frame: From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.]

Overall Survival [Time Frame: From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.]

Secondary ID(s)

20130394

PX-171-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/05/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00884312