Clinical Trials

Inclusion Criteria:

- Adult patients with a histologically confirmed diagnosis of metastatic or recurrent
soft tissue sarcoma

- Patients for whom treatment with doxorubicin is considered to be appropriate

- Left ventricular ejection fraction ≥ 50%

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Disease that is considered measurable according to RECIST v1.1.

Exclusion Criteria:

- Histologically or cytologically confirmed Kaposi's sarcoma, gastrointestinal stromal
tumor (GIST), extra-skeletal myxoid chondrosarcoma, epithelioid hemangioendothelioma,
and desmoid tumor

- Untreated metastases to the central nervous system

- Received previous treatment with anthracyclines and anthracenediones

- Previous radiation therapy to the mediastinal or pericardial area

- A known allergy to any of the treatment components

- Patient not willing to use suppositories

- Patients with a colostomy

- Patients who have had a colectomy (total or left hemicolectomy) with re-anastomosis

- Patients for whom administration of the suppositories are likely to cause pain (e.g.,
inflamed hemorrhoids, fissures, or lesions of the anus or rectum)

- Patients with fecal impaction, chronic idiopathic constipation, or chronic diarrhea or
alternating irritable bowel disease

- Patients with inflammatory bowel disease

- Previous treatment with an investigational agent or the non-approved use of a drug or
device within 4 weeks before study entry

- Uncontrolled diabetes mellitus

- Patients who require concomitant use of strong inhibitors or inducers of CYP3A4,
CYP2D6 or P- glycoprotein (P- gp)

Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.