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Trial record 1 of 1 for:    amxi-5001
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A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04503265
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : August 14, 2020
Information provided by (Responsible Party):
AtlasMedx, Incorporated

Brief Summary:
ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in 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. The purpose of Phase II (dose expansion) is to characterize the safety and efficacy of AMXI-5001.

Condition or disease Intervention/treatment Phase
Advanced Malignant Neoplasm Breast Cancer Ovarian Cancer Homologous Recombination Deficiency Drug: AMXI-5001:Dose Escalation Phase I Drug: AMXI-5001: Dose Expansion Phase II Phase 1 Phase 2

Detailed Description:
AMXI-5001 is a 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 80 participants. Participants receive oral AMXI-5001, twice daily, as monotherapy. The Dose Escalation Phase is a standard 3+3 escalation scheme. Following the identification of the Maximum Tolerated Dose in Phase I 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: AMXI-5001 Treatment
Single Arm Study, all participants will receive AMXI-5001.
Drug: AMXI-5001:Dose Escalation Phase I

Approximately 18-30 participants will be enrolled. Results from up to six (6) sequential groups will determine the Maximum Tolerated Dose and Recommended Phase II daily dose in the treatment of various cancers.

AMXI-5001 is administered orally twice daily, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule.

  • Dose escalation is a standard 3+3 escalation scheme
  • The Dose Limiting Toxicity (DLT) is assessed during Cycle 1 treatment
  • Patients are treated until disease progression or an intolerable adverse event occurs
  • The recommended dose for the Dose Expansion Phase is established from the DLT frequencies in the Dose Escalation Phase
Other Names:
  • Phase I
  • Dose Escalation

Drug: AMXI-5001: Dose Expansion Phase II

To further characterize the safety and clinical efficacy of AMXI-5001 at the Recommended Phase II Dose (RP2D), approximately 40 participants with HRD mutations will be enrolled in one of two cohorts based on their tumor type, HRD mutation, and prior treatment with PARP inhibitors.

AMXI-5001 is administered orally twice daily, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule. Each cycle is 28 days.

Other Names:
  • Phase II
  • Dose Expansion

Primary Outcome Measures :
  1. Determine dose-limiting toxicity (DLT) [ Time Frame: Approximately 12 months ]
    Determine the DLT of AMXI-5001 (in milligrams)

  2. Determine Objective Response Rate (ORR) [ Time Frame: Approximately 24 months ]
    Determine ORR as a percent of participants with Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 criteria relative to the efficacy population.

Secondary Outcome Measures :
  1. Determine Duration of Response (DOR) [ Time Frame: Approximately 24 months ]
    Determine DOR as the time from documentation of tumor response to disease progression.

  2. Determine Progression-free Survival (PFS) [ Time Frame: Approximately 24 months ]
    Determine PFS as the time from study enrollment until objective tumor progression or death.

  3. Determine Overall Survival (OS) [ Time Frame: Approximately 24 months ]
    Determine OS as the time from study entry to death from any cause.

  4. Measure concentration of AMXI-5001 in plasma samples [ Time Frame: Approximately 24 months ]
    Concentrations of AMXI-5001 in plasma samples at different time points are measured. Standard pharmacokinetic parameters will be calculated.

  5. Characterize safety profile of AMXI-5001 [ Time Frame: Approximately 24 months ]
    Characterize the safety profile of AMXI-5001 by incidence of treatment emergent adverse events, standard hematologic, chemistry, and ECG measurements.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria (Key Factors):

  1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:

    1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
    2. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
    3. Malignancy has progressed after standard therapy
  2. Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
  3. Eastern Co-operative Oncology Group (ECOG) PS 0-1

Exclusion Criteria (Key Factors):

  1. Receiving cancer treatment at the time of enrollment
  2. Any clinically significant disease or condition affecting a major organ system
  3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
  4. 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)
  5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04503265

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Contact: Bonnie Wettersten, MS (847) 644-9818

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United States, California
UCLA Department of Medicine - Hematology/Oncology Recruiting
Los Angeles, California, United States, 90404
United States, Florida
Moffitt Cancer Center and Research Institute Not yet recruiting
Tampa, Florida, United States, 33612
United States, Tennessee
The Sarah Cannon Research Institute/Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
AtlasMedx, Incorporated
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Study Director: Robert Reder, MD AtlasMedx, Inc
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Responsible Party: AtlasMedx, Incorporated Identifier: NCT04503265    
Other Study ID Numbers: ATLAS-101
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AtlasMedx, Incorporated:
PARP Inhibitor
Microtubule inhibitor
Additional relevant MeSH terms:
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