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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT02283359
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor is a potent slowly reversible covalent Selective Inhibitor of Nuclear Export (SINE) that specifically blocks the karyopherin protein Exportin 1 or XPO1.
  • Irinotecan — DRUG
    Irinotecan is a topoisomerase inhibitor and is approved by FDA to treat colorectal cancer. It is administered intravenously.

Study Details

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.

Key Dates

Start date
Dec 31, 2014
Status verified
Jan 2016
Primary completion
Dec 31, 2015
Completion
Jan 31, 2016

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor in Combination with Irinotecan
    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.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

Related Studies