Study of Selinexor and Doxorubicin in Advanced Soft Tissue Sarcomas

• Status: Active, not recruiting
• Trial end date: 2021-11-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1b study of investigational drug selinexor in combination with doxorubicin in patients with locally advanced or metastatic soft tissue sarcoma. The purpose of this study is to determine how safe and tolerable the combination is, as well as the best dose of the study drugs in this patient population.

Selinexor (also called KPT-330), works by trapping "tumor suppressor proteins" within the cell and thus causing the cancer cells to die or stop growing.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Karyopharm Therapeutics Inc
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Written informed consent

• Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

• Age ≥ 18 years.

• Patients must have histologically confirmed locally advanced/unresectable or metastatic soft tissue sarcoma.

• Patients must have not received prior doxorubicin.

• Patient must show evidence of progressive disease on study entry or newly diagnosed patients with de novo metastatic measurable disease

• Patient must have measureable disease as defined by RECIST 1.1.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Adequate hematopoietic function

• Adequate hepatic function:

• Adequate renal function

• Adequate cardiac function13

• Patients must agree to use methods of contraception as a agreed upon by the patient and study doctor

Exclusion Criteria:

• Patient is pregnant or lactating

• Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy, or participation in an investigational anti-cancer study ≤3 weeks prior to initiation of therapy.

• Major surgery within 4 weeks before initiation of therapy

• Unstable cardiovascular function

• Active, ongoing or uncontrolled active infection within one week prior to first dose.

• Malignancies other than disease under study within 2 years prior to Cycle 1, Day 1.

• Known to be HIV seropositive

• Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) RNA or hepatitis B virus (HBV) surface antigen (HBsAg)

• Patients with active CNS malignancy.

• Patients with any gastrointestinal dysfunctions that could interfere with the absorption of Selinexor or patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.

• Inability or unwillingness to take supportive medications such as anti-nausea and anti anorexia agents.

• In the opinion of the Investigator, patients who are significantly below their ideal body weight

• Serious psychiatric or medical conditions that could interfere with treatment

• Concurrent therapy with approved or investigational anticancer therapeutic agents

• Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study regimen or interpretation of patient safety or study results