A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies (Cancer)
a study on Malignant Neoplasm Neoplasms Breast Cancer Ovarian Cancer Homologous Recombination Deficiency Prostate Cancer Pancreatic Cancer Cancer, General Pancreatic Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Los Angeles 5368361, California 5332921 and other locations
- Dates
- study startedstudy ends around
Description
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.
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
Details
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.
Keywords
Advanced Malignant Neoplasm, Breast Cancer, Ovarian Cancer, Homologous Recombination Deficiency, Prostate Cancer, Pancreatic Cancer, Breast, Ovarian, Prostate, Pancreatic, Refractory, Cancer, Malignancy, BRCA, HRD, AMXI-5001, Progression, PARP Inhibitor, Microtubule inhibitor, Breast Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Pancreatic Neoplasms, Neoplasms, Disease Progression, Phase I as Topic Clinical Trials, Phase II as Topic Clinical Trials, AMXI-5001:Dose Escalation Phase I, AMXI-5001:Dose Expansion Phase II
Eligibility
You can join if…
Open to people ages 18 years and up
(Key Factors):
- Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
- Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
- Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
- Malignancy has progressed after standard therapy
- Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Eastern Co-operative Oncology Group (ECOG) PS 0-1
- Participant must be 18 years of age or older
- Able to understand and sign consent
You CAN'T join if...
(Key Factors):
- Receiving cancer treatment at the time of enrollment
- Any clinically significant disease or condition affecting a major organ system
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer
Locations
- University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
accepting new patients
Los Angeles 5368361 California 5332921 90404 United States - The University of Texas MD Anderson Cancer Center
accepting new patients
Houston 4699066 Texas 4736286 77030 United States - SCRI Oncology Partners
accepting new patients
Nashville 4644585 Tennessee 4662168 37203 United States - Johns Hopkins
accepting new patients
Baltimore 4347778 Maryland 4361885 21218 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- AtlasMedx, Incorporated
- Links
- Citation Sign up for this study
- ID
- NCT04503265
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 122 study participants
- Last Updated
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