Health TrialsbyHealthPanel

Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma

ConditionsSarcomaOsteosarcoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-40
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

This is a multicenter, open-label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of domatinostat in combination with sirolimus in adolescents and adults with relapsed or refractory sarcoma and osteosarcoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥12 and ≤40 years.

Histologically confirmed relapsed or refractory sarcoma (Phase 1) or osteosarcoma (Phase 2).

At least one prior standard systemic therapy regimen.

Not candidates for available therapies known to provide survival benefit.

Disqualifiers

Receiving another investigational agent.

Receiving concurrent anticancer therapy.

Known hypersensitivity to domatinostat or sirolimus.

Bone marrow-only disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Domatinostat

    Drug

    Tablet

  • Sirolimus

    Drug

    Tablet

Treatment groups

74 Participants
are divided into 3 treatment groups
Group A: Phase 1 Dose Escalation CohortExperimental treatment 2 interventions
Group B: Phase 2 Arm A (Surgical Complete Remission Osteosarcoma)Experimental treatment 2 interventions
Group C: Phase 2 Arm B (Measurable Osteosarcoma)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1: Maximum Tolerated Dose (MTD)

For the phase 1 portion, a standard 3+3 design will be used to determine the MTD and/or RP2D for the Phase 2 portion of this study.

Time frame
28 days
2

Phase 2: Arm A Event Free Surival

Event free survival (EFS) is defined as the duration of time from start of treatment to time of disease progression, secondary malignancy, or death, whichever occurs first.

Time frame
12 months
3

Phase 2: Arm B Event Free Surival

Event free survival (EFS) is defined as the duration of time from start of treatment to time of disease progression, secondary malignancy, or death, whichever occurs first.

Time frame
4 months

Secondary outcomes

1

Phase 2: Overall Survival

Overall Survival (OS) of phase 2 participants.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

National Pediatric Cancer Foundation

Collaborator

Healx USA, Inc

Collaborator

Source ClinicalTrials.gov
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