Clinical trial · Interventional
Phase 1 Clinical Trial MPC-2130 Treatment of Blood Cancers / Refractory Cancer
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
NCT00387153CI-TRIAL-00002759terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Last subject enrolled experienced bradycardia; study was terminated by Sponsor.
Summary
Brief summary (as posted)
Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MPC-2130 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- 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)
- description
- 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.
- measure
- Pharmacokinetics
- timeFrame
- First 5 days of treatment (Cycle 1)
- description
- Characterization of MPC-2130 pharmamcokinetics consisting of AUC, tmax, Cmax, half-life and clearance.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. -
References
Publications (0)
Data not yet available
No reference posted for this study.