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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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


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.


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. -

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

First 21 days on treatment (Cycle 1)

Safety Issue:

Yes

Principal Investigator

Richard Wenstrup, MD

Investigator Role:

Study Director

Investigator Affiliation:

Myriad Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

MPC-2130-04-002

NCT ID:

NCT00387153

Start Date:

August 2005

Completion Date:

October 2006

Related Keywords:

  • Cancer
  • Oncology
  • Cancer
  • Blood Cancers

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096