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

Primary Purpose

Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MPC-2130
Sponsored by
Myriad Therapeutics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Oncology, Cancer, Blood Cancers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • MD Anderson Cancer Center

Outcomes

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.
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.
Pharmacokinetics
Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.

Secondary Outcome Measures

Antiproliferative Activity
Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.

Full Information

First Posted
October 10, 2006
Last Updated
October 27, 2009
Sponsor
Myriad Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00387153
Brief Title
Phase 1 Clinical Trial MPC-2130 Treatment of Blood Cancers / Refractory Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
Last subject enrolled experienced bradycardia; study was terminated by Sponsor.
Study Start Date
August 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Myriad Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Oncology, Cancer, Blood Cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MPC-2130
Intervention Description
MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
First 21 days on treatment (Cycle 1)
Title
Pharmacokinetics
Description
Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.
Time Frame
First 5 days of treatment (Cycle 1)
Secondary Outcome Measure Information:
Title
Antiproliferative Activity
Description
Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.
Time Frame
Every 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Wenstrup, MD
Organizational Affiliation
Myriad Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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