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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.)
Sponsor:
Information provided by:
Myriad Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00387153
First received: October 10, 2006
Last updated: October 27, 2009
Last verified: October 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Cancer
 Drug: MPC-2130
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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) ] [ 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387153

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

No publications provided

Responsible Party: Richard Wenstrup, Myriad Therapeutics, Inc.
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Myriad Therapeutics, Inc.:
Oncology
Cancer
Blood Cancers

ClinicalTrials.gov processed this record on May 19, 2013