Clinical trial NCT00387153: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer
Keywords: Oncology
Cancer
Blood Cancers
Lead sponsor: Myriad Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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. -

Primary outcomes:
measure: 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.
timeFrame: First 21 days on treatment (Cycle 1)
measure: Pharmacokinetics
timeFrame: First 5 days of treatment (Cycle 1)
Secondary outcomes:
measure: Antiproliferative Activity
timeFrame: Every 42 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Myriad Therapeutics, Inc.
name: Richard Wenstrup, MD
role: STUDY_DIRECTOR
References: