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ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas

ConditionNeurological Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

this research study is evaluating the highest dose of ASTX727 that can be administered safely to recurrent/progressive non-enhancing IDH mutant gliomas patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be ≥18 years of age.

Participants must have histologically or cytologically confirmed glioma, with documented IDH1 and/or IDH2 gene-mutation.

Participants must have radiographic evidence of non-enhancing disease progression/recurrence per RANO criteria for low grade gliomas (LGG).

Patients who have received prior treatment with chemotherapy, radiation, or a combination of both are eligible. Also, patients who have not received any prior treatment for their glioma are also eligible.

Disqualifiers

Participants with enhancing disease on brain MRI.

Participants who received systemic anticancer therapy <28 days prior to registration. One exception: participants on lomustine/CCNU must wait at least 42 days from last date of drug administration to registration.

Participants who received an investigational agent <14 days prior to registration. In addition, the first dose of ASTX727 should not occur before a period ≥5 half-lives of the investigational agent has elapsed.

Participants with prior treatment with bevacizumab (Avastin) are excluded.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ASTX727

    Drug

    ASTX727 is made up of the 2 study drugs cedazuridine and decitabine. Cedazuridine is believed to work by slowing down how fast decitabine is broken down by the body. Decitabine is believed to work by blocking abnormal cells or cancer cells from growing.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: ASTX727 (Cedazuridine + Cytidine Antimetabolite Decitabine)Experimental treatment 1 intervention
Group B: Expansion CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerated dose

Participants will be enrolled at escalating doses using a standard 3+3 dose escalation design until the maximum administered dose is reached or until dose limiting toxicities result in the end of dose escalation. The maximum tolerated dose is the highest administered dose level at which participants experienced experienced 1 or fewer dose limiting toxicities.

Time frame
1 year

Secondary outcomes

1

Median Progression Free Survival

Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Disease progression will be assessed using the Response Assessment in Neuro-Oncology (RANO) Working Group updated response assessment criteria for low-grade Gliomas.

Time frame
From the time of randomization until disease progression or death, up to five years
2

Overall Survival

Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.

Time frame
From the time of randomization until death, up to five years
3

Response Rate

The number of participants achieving a complete or partial tumor response as assessed using the the Response Assessment in Neuro-Oncology (RANO) Working Group updated response assessment criteria for low-grade Gliomas.

Time frame
1 Year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Astex Pharmaceuticals, Inc.

Collaborator

Source ClinicalTrials.gov
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