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

Myriad Genetic Laboratories

Status and phase: Terminated; Phase 1

Conditions: Cancer

Treatments: Drug: MPC-2130

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387153

MPC-2130-04-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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. -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)