Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma
This study is currently recruiting participants.
Verified May 2013 by Prolexys Pharmaceuticals
Information provided by (Responsible Party):
First received: September 18, 2012
Last updated: May 31, 2013
Last verified: May 2013
To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1/2, Multi-center, Open Label, Dose Escalation, Safety, Efficacy and PK Study of PRLX 93936 Administered IV 3 Days a Week for 3 Weeks Followed by a 9 Day Rest Period in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma|
Resource links provided by NLM:
Further study details as provided by Prolexys Pharmaceuticals:
Primary Outcome Measures:
- Maximum Tolerated Dose [ Time Frame: Cycle 1 (28 days from first dose) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response to treatment [ Time Frame: Each cycle (assessed every 28 days starting from first dose, for up to 8 months) ] [ Designated as safety issue: No ]
- Time to response [ Time Frame: From date of first dose to date of response, assessed up to 8 months ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: From date of response to first documented progression or death, or date last known progression-free and alive at study discontinuation, assessed up to 8 months ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: From date of first dose to first documented progression, assessed up to 8 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: PRLX 93936
PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle
Drug: PRLX 93936
PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle, multiple cycles may be administered
- To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period, as treatment for patients with relapsed or relapsed/refractory multiple myeloma.
- To establish the dose of PRLX 93936 recommended for future studies.
- To characterize potential toxicities of PRLX 93936.
- To assess the pharmacokinetic profile of PRLX 93936.
- To evaluate response to treatment, time to response (TTR) and duration of response.
- To evaluate time to progression (TTP).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695590
|United States, Massachusetts|
|Tufts Medical Center||Withdrawn|
|Boston, Massachusetts, United States, 02111|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Amy Destefanis 617-632-6752 email@example.com|
|Principal Investigator: Robert Schlossman, MD|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Barbara Riff 919-843-7046 firstname.lastname@example.org|
|Contact: Katherine McKernan 919-966-4432 email@example.com|
|Principal Investigator: Peter Voorhees, MD|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Kimberly Oates 919-668-6524 firstname.lastname@example.org|
|Principal Investigator: Cristina Gasparetto, MD|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Sue O'Gara 513-604-3982 email@example.com|
|Principal Investigator: John Morris, MD|
|United States, Tennessee|
|Sarah Cannon Research Institute||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Cindy Farley 615-329-7237 firstname.lastname@example.org|
|Principal Investigator: Jesus G. Berdeja, MD|
Sponsors and Collaborators
|Principal Investigator:||Paul Richardson, MD||Dana-Farber Cancer Institute|