Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

AUGMENT-101 : A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

0+Age Over 0

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Lymphoblastic Leukaemia,Acute Myeloid Leukaemia,Leukaemia

Trial Overview Read MoreRead more

This phase I/II study is assessing the best dose level, safety and effectiveness of a new drug (SNDX-5613) in people with acute leukaemia.
 

This trial is treating patients with acute leukaemia.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Commercial Sponsor

Syndax Pharmaceuticals

Summary

This study has two phases. Phase 1 (Dose escalation), will consist of six sequential cohorts of escalating dose levels of SNDX-5613 (administered orally) to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Participants will be enrolled in one of six dose-escalation arms. Arm A: participants not receiving any strong CYP3A4 inhibitor/inducers or fluconazole. Arm B: Participants receiving any strong CYP3A4 inhibitors for antifungal prophylaxis. Arm C: participants receiving SNDX-5613 and cobicistat. Arm D: participants receiving fluconazole for antifungal prophylaxis. Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers. Arm F: participants receiving isavuconazole for antifungal prophylaxis. Phase 2 of the study involves participants being enrolled in 3 disease-specific expansion cohorts.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Jessica Ahern
PCCTU.HaemA@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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