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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. Identifier:
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.

Condition Intervention Phase
Drug: MPC-2130
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Myriad Therapeutics, Inc.:

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) ]
  • Pharmacokinetics [ Time Frame: First 5 days of treatment (Cycle 1) ]

Secondary Outcome Measures:
  • Antiproliferative Activity [ Time Frame: Every 42 days ]

Enrollment: 8
Study Start Date: August 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MPC-2130
    MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours
Detailed Description:
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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;
  2. Have cancer that is nonresponsive despite prior treatment with current standard of care regimens or for whom there are no available effective therapies;
  3. Have measurable or evaluable neoplastic disease;
  4. Be greater than or equal to age 18;
  5. Have and ECOG Performance Status score of less than or equal to 2;
  6. Have adequate organ function defined by:

    1. Liver function tests (AST & ALT) less than or equal to 3 times the upper limit of normal (ULN);
    2. Bilirubin less than or equal to 1.5 X ULN;
    3. Serum Creatinine less than or equal to 1.5 X ULN;
    4. Hemoglobin greater than or equal to 8.0 g/dL;
  7. Have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy;
  8. Have left ventricular ejection fraction (LVEF) of greater than or equal to 45% by multiple gated acquisition (MUGA) scan or echocardiogram.

Exclusion Criteria:

  1. Have had a prior serious, uncontrollable hypersensitivity reaction to Cremophor EL;
  2. 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);
  3. 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;
  4. Have previously enrolled in this trial. -
  Contacts and Locations
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Please refer to this study by its identifier: NCT00387153

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Myriad Therapeutics, Inc.
Study Director: Richard Wenstrup, MD Myriad Therapeutics, Inc.
  More Information

Responsible Party: Richard Wenstrup, Myriad Therapeutics, Inc. Identifier: NCT00387153     History of Changes
Other Study ID Numbers: MPC-2130-04-002
Study First Received: October 10, 2006
Results First Received: June 23, 2009
Last Updated: October 27, 2009

Keywords provided by Myriad Therapeutics, Inc.:
Blood Cancers processed this record on April 28, 2017