Status:
TERMINATED
Selinexor in Combination With Irinotecan in Adenocarcinoma of Stomach and Distal Esophagus
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 combi...
Detailed Description
This is an open label, single group, non-randomized, phase I study with cohort expansion that utilizes the standard 3+3 design for dose. The dose of selinexor will be escalated in combination with the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02283359
Start Date
December 1 2014
End Date
January 1 2016
Last Update
January 15 2016
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612