Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma
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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
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Sponsor:
Prolexys Pharmaceuticals
Information provided by (Responsible Party):
Prolexys Pharmaceuticals
Tracking Information | ||||
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First Submitted Date ICMJE | September 18, 2012 | |||
First Posted Date ICMJE | September 28, 2012 | |||
Last Update Posted Date | June 4, 2013 | |||
Study Start Date ICMJE | March 2012 | |||
Estimated Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Maximum Tolerated Dose [ Time Frame: Cycle 1 (28 days from first dose) ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01695590 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma | |||
Official Title ICMJE | 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 | |||
Brief Summary | To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Myeloma | |||
Intervention ICMJE | 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 |
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Study Arms | 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
Intervention: Drug: PRLX 93936 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | September 2014 | |||
Estimated Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01695590 | |||
Other Study ID Numbers ICMJE | PRLX93936-0002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Prolexys Pharmaceuticals | |||
Study Sponsor ICMJE | Prolexys Pharmaceuticals | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Prolexys Pharmaceuticals | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |