Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma

Conditions

• Metastatic Dedifferentiated Liposarcoma
• Metastatic Leiomyosarcoma
• Metastatic Myxofibrosarcoma
• Metastatic Sarcoma
• Metastatic Synovial Sarcoma
• Metastatic Undifferentiated Pleomorphic Sarcoma
• Unresectable Dedifferentiated Liposarcoma
• Unresectable Leiomyosarcoma
• Unresectable Myxofibrosarcoma
• Unresectable Sarcoma
• Unresectable Synovial Sarcoma
• Unresectable Undifferentiated Pleomorphic Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo tissue biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
  Given IV
• Peposertib — DRUG
  Given PO

Study Details

This phase I trial tests the safety, side effects, and best dose of combination therapy with liposomal doxorubicin and peposertib in treating patients with sarcoma that has spread from where it first started, to other places in the body (metastatic), or cannot be removed by surgery (unresectable) and for which no known cure is available (advanced). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Peposertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also enhance the activity of chemo- and radiotherapy. There is some pre-clinical evidence in animal models that combining peposertib with liposomal doxorubicin can shrink or stabilize certain types of cancer for longer than either drug alone, but it is not known if this will happen in people. Combination therapy with liposomal doxorubicin and peposertib may be effective in treating patients with advanced sarcoma.

Key Dates

Start date

Feb 6, 2024

Status verified

May 2026

Primary completion

Nov 3, 2026

Completion

Nov 3, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (peposertib, liposomal doxorubicin)
  Patients receive peposertib PO BID on days 1-28 of each cycle and liposomal doxorubicin IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity or withdrawal of consent. Patients undergo blood sample collection and CT or MRI throughout the trial. Patients also undergo tissue biopsy and ECHO or MUGA during screening and on the trial.

Primary Outcome Measure

Dose limiting toxicity (DLT) rate [ Time Frame: Up to 28 days ]

Locations (16)

Find similar trials in Los Angeles, CA

Related Studies

• Intravital Microscopy in Human Solid Tumors
  Recruiting · Mayo Clinic · Jacksonville, Florida
• Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors
  PHASE2 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas