Clinical trial · Interventional
Selinexor in Combination With Irinotecan in Adenocarcinoma of Stomach and Distal Esophagus
An Investigator Sponsored Phase 1a/1b Trial of Selinexor in Combination With Irinotecan in Patients With Adenocarcinoma of Stomach and Distal Esophagus
NCT02283359CI-TRIAL-00020558terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal Investigator left the institution
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Selinexor in Combination with Irinotecan
- description
- The first study drug is called selinexor (KPT-330). This drug is taken by mouth on days 1, 3, 8 and 10 of each cycle. The starting dose of selinexor will be dependent on the cohort in which the patient is enrolled into. Level -1: 25 mg/m\^2; Level 1: 40 mg/m\^2; Level 2: 50 mg/m\^2; Level 3: 65 mg/m\^2. The second drug is called irinotecan. This drug is given as intravenous (IV) infusion on days 1 and 8 of each cycle. Participants will receive the standard recommended dose: 125 mg/m\^2.
- interventionNames
- Drug: Selinexor
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- Up to 18 months
- description
- The MTD for study is defined as the highest dose level at which 1 or less of 6 patients experience a dose limiting toxicity (DLT).
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.