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Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: vorinostat (Drug); bortezomib (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

The purposes of this study are:

- To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat

and bortezomib in participants with advanced multiple myeloma

- To assess the safety and tolerability of this regimen and to document the participant's

clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Clinical Details

Official title: Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean Duration of Treatment With Vorinostat

Secondary outcome:

Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug

Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib

Clinical AE Summary

Laboratory AE Summary

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults with refractory or relapsed multiple myeloma

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to

determine participant's ability to perform daily activities)

- Adequate bone marrow reserve

- Adequate hepatic and renal function

- Ability to swallow capsules

- 3 weeks or more since prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

- Participants who plan to have a bone marrow transplant within 4 weeks of start of

treatment

- Participants with prior treatment with other investigational agents with a similar

anti-tumor mechanism

- Participants with other active/uncontrolled clinically significant illness

- Pregnant or nursing female participants

- Participants who received bortezomib within 3 months of start of this trial

Locations and Contacts

Additional Information

Starting date: September 2005
Last updated: May 5, 2015

Page last updated: August 23, 2015

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