Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours
MD Anderson Cancer Center
Houston, Texas, United States
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.
Time frame: First 21 days on treatment (Cycle 1)
Pharmacokinetics
Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.
Time frame: First 5 days of treatment (Cycle 1)
Antiproliferative Activity
Observation for any evidence of antiproliferative activity of MPC-2130 in treatment of a variety ofrefractory neoplasias.
Time frame: Every 42 days
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