Selinexor in Combination With Irinotecan in Adenocarcinoma of Stomach and Distal Esophagus

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to see whether the combination of selinexor (KPT-330) and irinotecan can help people with esophageal or stomach cancer. Researchers also want to find out if the combination of selinexor (KPT-330) and irinotecan is safe and tolerable.

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

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Treatments: Camptothecin; Irinotecan

Criteria

Inclusion Criteria:

• Must have histologically confirmed gastric, gastro-esophageal junction or distal esophageal adenocarcinoma (predominant histology) that is recurrent, metastatic or unresectable

• Must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1

• Must have received at least one line but less than three lines of prior systemic therapies and have either progressed or intolerant to prior therapies. Patients who have received adjuvant/neoadjuvant therapy within last one year will be eligible as well.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

• Life expectancy of greater than 3 months

• Must have normal organ and marrow function

• Women of child-bearing potential (WOCBP) must agree to use dual methods of contraception and have a negative serum pregnancy test at screening. Male participants must use an effective barrier method of contraception if sexually active with a WOCBP. For both male and female participants, effective methods of contraception must be used throughout the study and for three months following the last dose.

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Have had chemotherapy, biologic therapy or radiotherapy within 3 weeks prior to entering the study

• Are receiving any other investigational agents for anti-cancer treatment within 3 weeks of starting study medication

• Symptomatic central nervous system (CNS) metastases

• Progression on irinotecan containing regimen

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to irinotecan

• Major surgery within 2 weeks before cycle 1 Day 1 (C1D1)

• Unstable cardiovascular function

• Patients who are pregnant or lactating

• Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study.

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

• Any underlying condition that would significantly interfere with the absorption of an oral medication

• > Grade 2 peripheral neuropathy at baseline

• Serious psychiatric or medical conditions that could interfere with treatment

• Concurrent therapy with approved or investigational anticancer therapeutic other than steroids

• History of gastrointestinal perforation and/or fistulae within 6 months prior to C1D1

• Use of strong CYP3A4 inducers or inhibitors within 2 weeks of starting study medication