Clinical trial · Interventional
Phase 1 Study of MKC-1 in Patients With Advanced Cancer
Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies
NCT00656461CI-TRIAL-00002821completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 study to determine the highest dose of MKC-1 that may be administered daily on a continuous basis for patients with advanced or refractory solid tumors.
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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MKC-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: MKC-1
Primary outcomes (1)
- measure
- Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors.
- timeFrame
- Throughout study participation
Secondary outcomes (1)
- measure
- Determine evidence of benefit in cancer patients when MKC-1 is administered orally twice a day (bid) continuously by evaluating tumor response and/or tumor marker improvement.
- timeFrame
- During study participation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. * Age greater than or equal to 18 years. * ECOG performance status ≤1 * ANC greater than or equal to 1,500/mm3; * Platelets greater than or equal to 100,000/mm3 * creatinine ≤1.5 times institutional upper limit of normal (ULN) * T Bili within normal limits; * AST and ALT less than or equal to 2.5 times ULN; and * albumin greater than or equal to 3.0 g/dL * have measurable disease by RECIST, radiographically evaluable disease, or detectable disease * women of child-bearing potential and men must agree to use adequate contraception * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Have previously received MKC-1. * Have received radiation to greater than 25% of the bone marrow. * Have had anti-cancer therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Are concurrently receiving any other investigational agents while on study. * Have known brain metastases * Have any condition that impairs the ability to swallow and retain MKC-1 capsules. * Uncontrolled intercurrent illness * Are pregnant or breastfeeding * HIV-positive patients * Patients with uncontrolled diabetes
References
Publications (0)
Data not yet available
No reference posted for this study.