Phase 1 Clinical Trial MPC-2130 Treatment of Blood Cancers / Refractory Cancer
This study has been terminated.
(Last subject enrolled experienced bradycardia; study was terminated by Sponsor.)
Information provided by:
Myriad Therapeutics, Inc.
First received: October 10, 2006
Last updated: October 27, 2009
Last verified: October 2009
Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase 1 OL, Dose Escalating, Multiple Dose Study To Determine The Safety, Tolerability, MTD, And Pharmacokinetics Of MPC-2130 Administered As Daily IV Infusions For 5 Days, Repeated Every 21 Days, In Patients With Refractory Cancer
Primary Outcome Measures:
- Number of Subjects With Dose Limiting Toxicities and Grade 3/4 Adverse Events. As a General Guideline, a Severe Adverse Event is Considered Grade 3, and a Life Threatening or Disabling Adverse Event is Considered Grade 4. [ Time Frame: First 21 days on treatment (Cycle 1) ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: First 5 days of treatment (Cycle 1) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Antiproliferative Activity [ Time Frame: Every 42 days ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2006 (Final data collection date for primary outcome measure)
MPC-2130 Phase 1 Clinical study was designed to evaluate its safety and pharmacokinetic profile in patients with advanced metastatic tumors or blood cancers as well as refractory cancers that progressed despite previous chemotherapy.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Be capable of understanding the informed consent form (ICF) and complying with the protocol, and must sign the ICF prior to the performance of any study related procedures;
- Have cancer that is nonresponsive despite prior treatment with current standard of care regimens or for whom there are no available effective therapies;
- Have measurable or evaluable neoplastic disease;
- Be greater than or equal to age 18;
- Have and ECOG Performance Status score of less than or equal to 2;
Have adequate organ function defined by:
- Liver function tests (AST & ALT) less than or equal to 3 times the upper limit of normal (ULN);
- Bilirubin less than or equal to 1.5 X ULN;
- Serum Creatinine less than or equal to 1.5 X ULN;
- Hemoglobin greater than or equal to 8.0 g/dL;
- Have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy;
- Have left ventricular ejection fraction (LVEF) of greater than or equal to 45% by multiple gated acquisition (MUGA) scan or echocardiogram.
- Have had a prior serious, uncontrollable hypersensitivity reaction to Cremophor EL;
- Be pregnant or lactating (women of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records);
- Receive any other anticancer treatment or investigational therapy within 14 days prior to day 1; or within 6 weeks after prior mitomycin C or nitrosourea. Patients with advanced prostate cancer may continue to receive leutinizing hormone-releasing hormone (LHRH) therapy while in this study;
- Have previously enrolled in this trial. -
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387153
|MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
Myriad Therapeutics, Inc.
||Richard Wenstrup, MD
||Myriad Therapeutics, Inc.
No publications provided
||Richard Wenstrup, Myriad Therapeutics, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 10, 2006
|Results First Received:
||June 23, 2009
||October 27, 2009
||United States: Food and Drug Administration
United States: Institutional Review Board
Keywords provided by Myriad Therapeutics, Inc.:
ClinicalTrials.gov processed this record on March 06, 2014