About this trial

A randomized study to determine safety and efficacy of a series of subcutaneous (SC) injections of HAL in patients with CINP, compared to matching placebo injections. After that, subjects may have the option to enter an Open Label extension phase, where available, in which all subjects will receive Halneuron.

Eligibility criteria

Qualifiers

Male or female patients aged ≥18 years.

Neuropathic pain has been present and is attributed to platinum and/or taxane chemotherapy.

Patient has received a cancer chemotherapy regimen that included taxanes and/or platinum and has no active or discernible disease progression.

Disqualifiers

Current neuropathic pain with symptoms similar to CINP but attributed to causes other than platinum or taxane chemotherapy.

Patients who have received HAL at any time prior to screening.

Trial design

Treatments tested in this trial

  • Halneuron
  • Placebo
  • Halneuron (Open Label Extension)

Treatment groups

240 Participants
are divided into 3 treatment groups

Locations

25
Alabama
Central Recruiting Site35660, Sheffield United States
Arizona
Central Recruiting Site85308, Glendale United States
Central Recruiting Site85022, Phoenix United States
California
Central Recruiting Site95628, Fair Oaks United States

Sponsors and collaborators

Dogwood Therapeutics Inc.

Lead sponsor