NCT00109109

A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Multiple Myeloma (0683-004)

Terminated Phase 1 Last updated 14 November 2019

What this trial tests

Phase 1 trial testing MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months in Multiple Myeloma in 60 participants. Terminated before completion.

Timeline

1 December 2003

Primary endpoint
14 February 2006

14 February 2006

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 December 2003
Primary completion	14 February 2006
Estimated completion	14 February 2006

Drugs / interventions tested

• MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment - Up to 8 Cycles or 6 months

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purposes of this study are:

* To determine the maximum tolerated dose (MTD) of SAHA administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma;
* To assess the safety and overall response rate to SAHA in patients with advanced multiple myeloma.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phase I trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced multiple myeloma.
   Richardson P, Mitsiades C, Colson K, Reilly E, et al · · 2008 · cited 151× · PMID 18297527 · DOI 10.1080/10428190701817258
2. Histone deacetylase inhibitors: clinical implications for hematological malignancies.
   Tambaro FP, Dell'aversana C, Carafa V, Nebbioso A, et al · · 2010 · cited 13× · PMID 22704087 · DOI 10.1007/s13148-010-0006-2