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

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

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Drug: MPC-2130

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
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Dose limiting toxicities include any grade 3 nonhematological toxicity(excluding nausea/vomiting or alopecia); greater than grade 3 nausea/vomiting uncontrolled by aggressive antiemetic support; grade 4 neutropenia lasting more than 5 days, or any febrile (38.5° C or 101° F) grade 3/4 neutropenia; grade 4 thrombocytopenia. An adverse event is any reaction, side effect, or other untoward event, regardless of relationship to MPC-2130 that occurs any time after the beginning of the first IV infusion of MPC-2130 until 30 days after MPC-2130 discontinuation.	First 21 days on treatment (Cycle 1)
Pharmacokinetics	Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.	First 5 days of treatment (Cycle 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiproliferative Activity	Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.	Every 42 days

Collaborators and Investigators

• Sponsor: Myriad Therapeutics, Inc.
• Investigators: Study Director: Richard Wenstrup, MD, Myriad Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: October 10, 2006
• First Submitted That Met QC Criteria: October 10, 2006
• First Posted (Estimate): October 12, 2006

Study Record Updates

• Last Update Posted (Estimate): November 3, 2009
• Last Update Submitted That Met QC Criteria: October 27, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Cancer; Oncology; Blood Cancers
• Other Study ID Numbers: MPC-2130-04-002