Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01695590|
Recruitment Status : Unknown
Verified May 2013 by Prolexys Pharmaceuticals.
Recruitment status was: Recruiting
First Posted : September 28, 2012
Last Update Posted : June 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: PRLX 93936||Phase 1 Phase 2|
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||September 2014|
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
- Maximum Tolerated Dose [ Time Frame: Cycle 1 (28 days from first dose) ]
- Response to treatment [ Time Frame: Each cycle (assessed every 28 days starting from first dose, for up to 8 months) ]
- Time to response [ Time Frame: From date of first dose to date of response, assessed up to 8 months ]
- 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 ]
- Time to progression [ Time Frame: From date of first dose to first documented progression, assessed up to 8 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Katherine McKernan 919-966-4432 firstname.lastname@example.org|
|Principal Investigator: Peter Voorhees, MD|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Kimberly Oates 919-668-6524 email@example.com|
|Principal Investigator: Cristina Gasparetto, MD|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Sue O'Gara 513-604-3982 firstname.lastname@example.org|
|Principal Investigator: John Morris, MD|
|United States, Tennessee|
|Sarah Cannon Research Institute||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Cindy Farley 615-329-7237 email@example.com|
|Principal Investigator: Jesus G. Berdeja, MD|
|Principal Investigator:||Paul Richardson, MD||Dana-Farber Cancer Institute|