Spots Global Cancer Trial Database for A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
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Trial Identification
Brief Title: A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
Official Title: A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies
Study ID: NCT04503265
Study Description
Brief Summary: ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.
Detailed Description: AMXI-5001 is an orally available dual PARP (poly adenosine diphosphate \[ADP\] ribose polymerase) and microtubule polymerization inhibitor. ATLAS-101 is a Phase I/II, open label, multi-center, non-randomized Dose Escalation and Dose Expansion study in participants with advanced malignancies. Study enrollment is approximately 122 participants. All participants receive oral AMXI-5001, twice daily, as monotherapy. Following Phase I (Dose Escalation) to identify the Maximum Tolerated Dose and the Recommended Dose for use in Phase II, additional participants will be enrolled into the Dose Expansion Phase to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Honor Health, Phoenix, Arizona, United States
University of California, Davis (UC Davis), Davis, California, United States
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology, Los Angeles, California, United States
Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Johns Hopkins, Baltimore, Maryland, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
Vanderbilt University, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Pamela Munster, MD
Affiliation: AtlasMedx, Incorporated
Role: STUDY_DIRECTOR
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