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. -
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 28, 2014