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

Study Overview
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Brief Summary
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Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.

Detailed Description
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: MPC-2130


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiproliferative Activity | Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias. | Every 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology, Cancer, Blood Cancers