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

NCT00387153 | Terminated Phase 1 Results

• 1 other identifier: MPC-2130-04-002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

Oncology; Cancer; Blood Cancers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Antiproliferative Activity

  Every 42 days

Interventions

MPC-2130 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Have cancer that is nonresponsive despite prior treatment with current standard of care regimens or for whom there are no available effective therapies;
• Have measurable or evaluable neoplastic disease;
• Be greater than or equal to age 18;
• Have and ECOG Performance Status score of less than or equal to 2;
• Have adequate organ function defined by:
• Liver function tests (AST \& ALT) less than or equal to 3 times the upper limit of normal (ULN);
• Bilirubin less than or equal to 1.5 X ULN;
• Serum Creatinine less than or equal to 1.5 X ULN;
• Hemoglobin greater than or equal to 8.0 g/dL;
• Have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy;
• Have left ventricular ejection fraction (LVEF) of greater than or equal to 45% by multiple gated acquisition (MUGA) scan or echocardiogram.

You may not qualify if:

• Have had a prior serious, uncontrollable hypersensitivity reaction to Cremophor EL;
• 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);
• 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;
• Have previously enrolled in this trial. -

Sponsors & Collaborators

• Myriad Therapeutics, Inc.: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Richard Wenstrup, MD, VP Chief Medical Officer
• Organization: Myriad Therapeutics, Inc.

rwenstru@myriad.com

801-584-3009

Study Officials

• Richard Wenstrup, MD

  Myriad Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: August 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: November 3, 2009
• Results First Posted: October 22, 2009

Record last verified: 2009-10

Locations

US (1)