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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00387153
• Other study ID #: MPC-2130-04-002
• Status: Terminated
• Phase: Phase 1
• First received: October 10, 2006
• Last updated: October 27, 2009
• Start date: August 2005
• Est. completion date: October 2006

Study information

• Verified date: October 2009
• Source: Myriad Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Myriad Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		First 21 days on treatment (Cycle 1)	Yes
Primary	Pharmacokinetics		First 5 days of treatment (Cycle 1)	No
Secondary	Antiproliferative Activity		Every 42 days	No