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

NCT ID: NCT00387153

Last Updated: 2009-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-10-31

Brief Summary

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

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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MPC-2130

MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours

Intervention Type: DRUG

Eligibility 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. -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Myriad Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Myriad Therapeutics, Inc.

Principal Investigators

Richard Wenstrup, MD

Role: STUDY_DIRECTOR

Myriad Therapeutics, Inc.

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MPC-2130-04-002

Identifier Type: -

Identifier Source: org_study_id