Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients

Karyopharm Therapeutics

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Diabetic Foot Ulcers

Treatments: Other: Vehicle Gel; Drug: Selinexor; Other: Standard-of-Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02367690

KCP-330-501

Details and patient eligibility

About

Patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. This is a randomized trial. All patients will receive standard-of-care treatment. Additionally, some patients will receive treatment with topical Selinexor gel and some will receive topical placebo gel.

Full description

Approximately 30 patients who meet the eligibility criteria will be enrolled. Eligible patients with diabetic foot ulcers will be screened, randomized, treated, and followed for complete ulcer closure.

After screening, qualified patients will be treated for up to 12 weeks. Patients who achieve complete ulcer closure will be followed for an additional 12 weeks.

All patients will receive standard-of-care treatment. After randomization some patients will be treated with topical Selinexor gel twice weekly and some patients will be treated with a topical placebo gel twice weekly. Patients receiving Selinexor will be assigned to a sequential treatment cohort, either a 10 μM (μmol/L), 30 μM, or 70 μM dose.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has a clinical diagnosis of Type I or Type II diabetes mellitus with an HbA1c ≤ 10.0 and has a BMI ≤40.

• The DFU(s) to be treated must be:

  • Anatomically discrete,
  • Non-healing, but has persisted for ≤12 months
  • Measures 1 cm2 ≤ area ≤ 5 cm2 following debridement,
  • Has a Wagner Grade 1 (i.e., not involving bone, muscle, tendons, or ligaments),
  • The Target DFU is located distal to the ankle (i.e., below the malleolus), and
  • Is able to be adequately off-loaded.

• The patient has adequate arterial blood supply in the affected limb at screening.

• Patient has the inability to perceive 10 grams pressure in the peri-ulcer area and other regions of the affected foot and toes using Semmes-Weinstein 5.07 monofilament at screening.

Exclusion criteria

• Patient has a foot ulcer that is clearly of non-diabetic pathophysiology.
• Patient has more than two (2) DFUs on the target lower extremity.
• DFU is clinically infected.
• Patient has active osteomyelitis of the foot or active, uncontrolled, connective tissue disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Cohort 1 will be randomized to one of the following treatment groups: a) Standard-of-care (SOC) + Selinexor gel, 10 μM , b) SOC + vehicle gel c) SOC alone.

Treatment:

Other: Standard-of-Care

Other: Vehicle Gel

Drug: Selinexor

Cohort 2

Experimental group

Description:

Cohort 2 will be randomized to one of the following treatment groups: 1. Standard-of-care (SOC) + Selinexor gel, 30 μM 2. SOC + vehicle gel 3. SOC alone.

Treatment:

Other: Standard-of-Care

Other: Vehicle Gel

Drug: Selinexor

Cohort 3

Experimental group

Description:

Cohort 3 will be randomized to one of the following treatment groups: 1. Standard-of-care (SOC) + Selinexor gel, 70 μM 2. SOC + vehicle gel 3. SOC alone.

Treatment:

Other: Standard-of-Care

Other: Vehicle Gel

Drug: Selinexor