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

Conditions

• Colorectal Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
  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.
• Oxaliplatin — DRUG
  85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle
• 5-FU — DRUG
  400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3
• Folinic Acid — DRUG
  400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle

Study Details

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.

Key Dates

Start date

Mar 31, 2015

Status verified

Feb 2022

Primary completion

Mar 9, 2017

Completion

Mar 9, 2017

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Selinexor + mFOLFOX6
  Different Dose Levels of Selinexor will be evaluated in combination with mFOLFOX6 (see interventions)

Primary Outcome Measure

Numbers of Patients With Dose Limiting Toxicities [ Time Frame: 28 days of treatment ]