Oral AMXT 1501 Dicaprate in Combination With IV DFMO (NCT05500508) | Clinical Trial Compass
TerminatedPhase 1/2
Oral AMXT 1501 Dicaprate in Combination With IV DFMO
Stopped: Required re-formulation of DFMO from IV to capsule to maintain safety
United States15 participantsStarted 2022-11-29
Plain-language summary
A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
* IMPORTANT NOTE- Younger 12-17 year old patients are also eligible for this study if they meet the noted DIPG or DMG criteria noted below, which is separate from Patient Diagnosed with Advanced Solid Tumors.
* Patients will be eligible for study participation only if they meet ALL the inclusion criteria applicable to their diagnosis.
INCLUSION FOR PATIENTS DIAGNOSED WITH ADVANCED SOLID TUMORS
* Understand and sign written IRB-approved informed consent form and be willing to comply with all study procedures.
* Diagnosed with unresectable, locally advanced, or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failed. Planned tumor types for evaluation include:
* Platinum resistant ovarian cancer (including - primary peritoneal cancer and fallopian tube cancer)
* Breast cancer
* Papillary thyroid cancer
* Head and neck cancer
* Gastric cancer
* Non-small cell lung cancer (NSCLC)
* Mesothelioma: Pleural and peritoneal
* Esophageal
* Endometrial cancer
* Cervical
* Melanoma
* Colorectal cancers (colon, rectal)
* Grade 4 Gliomas (including both IDH WT and IDH-mutant astrocytoma)
* Must be ≥18 years of age.
* Histologically or cytologically documented disease.
* Has evaluable or measurable disease by RECIST v1.1 or mRECIST criteria.
o For patients with Grade 4 glioma, has evaluable or measurable disease by RANO (Appendix 5).
* Provide tumor tissue from biopsy taken during Screenin…
What they're measuring
1
Determine DLTs and RP2Ds in AMXT 1501 in combination with IV DFMO
Timeframe: 1 year
2
Determine safety and tolerability of AMXT1501 in combination with IV DFMO