NCT02384850

Phase 1 Trial To Evaluate mFOLFOX6 With Selinexor In Patients With Metastatic Colorectal Cancer

An Investigator Initiated Phase 1 Trial To Evaluate mFOLFOX6 With Selinexor (KPT-330), An Oral Selective Inhibitor Of Nuclear Export (SINE), In Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: GSO Global Clinical Research BV · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the combination treatment of established chemotherapy regimen mFOLFOX6 with Selinexor, an oral Selective Inhibitor Of Nuclear Export, in patients with metastatic Colorectal Cancer. The purpose is to determine the maximum tolerated dose (MTD) of selinexor in combination with mFOLFOX6.

Detailed description

This was a multi center, open-label, non-randomized phase I trial study to determine the MTD of a combination of mFOLFOX6 (Folinic Acid (Leucovorin)-Fluorouracil-Oxaliplatin) and selinexor in patients with metastatic colorectal cancer. After screening and registration in the study, all enrolled patients were to be treated with oxaliplatin (85 mg/m² IV over 2 hours, Day 1), 5-FU (5-Fluorouracil 400 mg/m2 IV bolus, Day 1), leukovorin (400 mg/m2 IV over 2 hours, Day 1), and 5-FU (2,400 mg/m² continuous infusion, Days 1-3) every 2 weeks and escalating doses of selinexor as follows: Patients in Dose Level 1 were to receive oral selinexor 40 mg on day 1, 3, and 8. Patients in Dose Level 2 were to receive oral selinexor 60 mg on day 1, 3, and 8. Patients in Dose Level 3 were to receive oral selinexor 80 mg on day 1, 3, and 8. Patients in Dose Level -1 were to receive oral selinexor 20 mg on day 1, 3, and 8. The MTD was defined as the highest dose level at which six patients had been treated with no toxicity and tolerance of the dose escalation of Selinexor with mFOLFOX6 was evaluated. Six patients were to be initially treated in a cohort. Safety data were monitored in real time. As soon as last patient of the cohort (either 6th or 9th) reached day 28, safety data of all patients within that cohort were reviewed for decision about opening up a new cohort by moving to the next dose level or expand the cohort or discontinue dose escalation.

Conditions

• Colorectal Neoplasm

Interventions

Type	Name	Description
DRUG	Selinexor	Dose Level 1: 40 mg on day 1, 3 and 8 in a two-weeks cycle. Dose Level 2: 60 mg on day 1, 3 and 8 in a two-weeks cycle. Dose Level 3: 80 mg on day 1, 3 and 8 in a two-weeks cycle. Dose Level -1: 20 mg on day 1, 3 and 8 in a two-weeks cycle.
DRUG	Oxaliplatin	85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle
DRUG	5-FU	400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3
DRUG	Folinic Acid	400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-03-09
• Completion: 2017-03-09
• First posted: 2015-03-10
• Last updated: 2022-04-08
• Results posted: 2022-04-08

Locations

2 sites across 2 countries: Belgium, Germany