Phase 1 Clinical Trial MPC-2130 Treatment of Blood Cancers / Refractory Cancer

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. Identifier: NCT00387153
Recruitment Status : Terminated (Last subject enrolled experienced bradycardia; study was terminated by Sponsor.)
First Posted : October 12, 2006
Results First Posted : October 22, 2009
Last Update Posted : November 3, 2009
Information provided by:
Myriad Therapeutics, Inc.

Brief Summary:
Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.

Condition or disease Intervention/treatment Phase
Cancer Drug: MPC-2130 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Intervention Details:
    Drug: MPC-2130
    MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours

Primary Outcome Measures :
  1. 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) ]
  2. Pharmacokinetics [ Time Frame: First 5 days of treatment (Cycle 1) ]

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

Information from the National Library of Medicine

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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. -

Information from the National Library of Medicine

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 identifier (NCT number): 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.

Responsible Party: Richard Wenstrup, Myriad Therapeutics, Inc. Identifier: NCT00387153     History of Changes
Other Study ID Numbers: MPC-2130-04-002
First Posted: October 12, 2006    Key Record Dates
Results First Posted: October 22, 2009
Last Update Posted: November 3, 2009
Last Verified: October 2009

Keywords provided by Myriad Therapeutics, Inc.:
Blood Cancers