Clinical trial · Interventional
Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma
Dose Finding Phase 1 Study of the Treatment of Metastatic Melanoma With MPC-6827 in Combination With Temozolomide
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, dose finding, multiple-dose study in subjects with metastatic melanoma. Three dose levels of MPC-6827 will be administered with temozolomide to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, determination of dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with temozolomide.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MPC-6827 + Temozolomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety and Tolerability; Maximum Tolerated Dose
- timeFrame
- After each cohort is enrolled
Secondary outcomes (2)
- measure
- Pharmacokinetics
- timeFrame
- Cycle 1
- measure
- Antitumor Activity
- timeFrame
- Screening, end of each cycle, end of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven melanoma * For subjects with brain metastases that require radiation, therapy must have been completed at least 4 weeks prior to Day 1 of Study Drug * Have unresectable melanoma with measurable metastases * Be a minimum of 4 weeks since prior surgical resection or major surgical procedure and a minimum of 2 weeks since chemotherapy/ biochemotherapy * Performance score of Karnofsky ≥ 60%, or Eastern Cooperative Oncology Group (ECOG) ≤ 2, or WHO ≤ 2 * If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week Exclusion Criteria: * Hypersensitivity to Cremophor EL * Have current/active intratumor hemorrhage by CT/MRI within 3 weeks prior to Day 1 of Study Drug confirmed by CT/MRI * Have ocular melanoma * Have primary intradural melanoma or leptomeningeal involvement * Have cardiovascular disease (unstable angina or MI) * Have cerebrovascular disease (stroke and/or TIA) * Have uncontrolled hypertension * Have a cardiac ejection fraction \< 50% * Have Troponin-I elevated above the normal range
References
Publications (0)
Data not yet available