Search > Soft Tissue Sarcoma
74 Participants NeededMy employer runs this trial

Domatinostat + Sirolimus for Bone Cancer

Recruiting at 3 trial locations
JC
Overseen ByJessica Crimella
Age: < 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Must not be taking: CYP3A4/P-gp interactors, Antiretrovirals
Disqualifiers: CNS metastases, Recent cardiac disease, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

AA

Amy Armstrong, MD

Principal Investigator

Washington University School of Medicine

JM

Jonathan Metts, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults (ages 12-40) with relapsed or treatment-resistant sarcoma or osteosarcoma who have already tried standard therapies. Participants must be able to swallow tablets, have good organ function, not be pregnant or breastfeeding, and meet certain health criteria.

Inclusion Criteria

Life expectancy ≥16 weeks
I am between 12 and 40 years old.
Ability to provide informed consent/assent
See 8 more

Exclusion Criteria

Receiving another investigational agent
History of solid organ transplantation
I do not have any uncontrolled infections or serious illnesses.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

Participants with relapsed or refractory sarcoma receive domatinostat plus sirolimus with dose escalation to determine the MTD and/or RP2D

4 weeks
Multiple visits for dose escalation monitoring

Phase 2 Treatment

Participants receive domatinostat plus sirolimus at the RP2D. Arm A includes patients with complete surgical remission, and Arm B includes patients with measurable disease

12 months for Arm A, 4 months for Arm B
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years
Periodic visits for survival monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Domatinostat
  • Sirolimus

Trial Overview

The study tests a combination of two drugs—domatinostat and sirolimus—to see if they are safe and effective in treating people with hard-to-treat sarcomas. All participants receive both drugs; there is no placebo group.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Phase 2 Arm B (Measurable Osteosarcoma)Experimental Treatment2 Interventions
Group II: Phase 2 Arm A (Surgical Complete Remission Osteosarcoma)Experimental Treatment2 Interventions
Group III: Phase 1 Dose Escalation CohortExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

National Pediatric Cancer Foundation

Collaborator

Trials
8
Recruited
300+

Healx USA, Inc

Collaborator

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