Proof of Principle Study Evaluating Gonyautoxins NEURO SERUM, on Chemotherapy-induced Peripheral … (NCT05052398) | Clinical Trial Compass
UnknownPhase 1/2
Proof of Principle Study Evaluating Gonyautoxins NEURO SERUM, on Chemotherapy-induced Peripheral Neuropathy
Brazil52 participantsStarted 2021-01-14
Plain-language summary
Proof-of-concept study to assess the effects of gonyautoxins (PSP NEURO SERUM) on safety and tactile sensitivity on patients with chemotherapy-induced peripheral neuropathy (CIPN). This is a multicenter, prospective proof-of-concept study in patients with solid tumors affected by CIPN. The study will be divided into two parts: Part 1 will assess the activity and tolerability of PSP NEURO SERUM and part 2 consists of a randomized cohort that will compare the activity of PSP NEURO SERUM vs placebo. Part 2 will depend on the results of part 1. If there are less than 8 responses in part 1, the study will be interrupted, and it will not be recommended to proceed with part 2.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Age ≥18 years
✓. Histological diagnosis of cancer (hematologic or solid tumors).
✓. Part 1: Treatment with antineoplastic agents that induce peripheral neuropathy in neoadjuvant, adjuvant, or metastatic scenario; Part 2: Treatment with taxanes peripheral neuropathy inducers in the neoadjuvant, adjuvant, or metastatic scenario.
✓. Peripheral sensory neuropathy grade 2 or higher on upper limbs as per NCI-CTCAE v5.0. and with alteration of the Semmes Weinstein monofilament test.
✓. Part 1: Diagnosis of peripheral sensory neuropathy during treatment with antineoplastic agents drugs that induce peripheral neuropathy or up to 2 weeks after the last chemotherapy infusion; Part 2: Diagnosis of peripheral sensory neuropathy during treatment with peripheral neuropathy-inducing taxanes or up to 2 weeks after last chemotherapy infusion.
Exclusion criteria
✕. Patients using neuropathic pain modulators will be allowed if there is no dose adjustments in the last 2 weeks and if sensory symptoms persist related to CIPN, or if the use is for another indication.
What they're measuring
1
Evaluate the change in response caused by PSP NEURO SERUM on the tactile sensation from baseline to day 28.
✕. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
✕0. Documented willingness to use an effective contraceptive method while participate in the study for male patients with partners or female participants with the potential to become pregnant.
✕1. Part 1: Hand skin and cuticles must be intact. Part 2: Skin of hands, feet and cuticles must be intact.
✕. Prior treatment with gonyautoxins or any small molecule neurotoxins.
✕. Female participants who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or intend to become pregnant within 3 months.
✕. History of peripheral sensory neuropathy attributed to any cause other than chemotherapy.
✕. Patients receiving systemic treatment that has among its common side effects (\> 1%) peripheral neuropathy, or who have received the same within the last 2 weeks. The use during the study of systemic drugs such as hormone therapy (e.g. tamoxifen, aromatase inhibitor, etc), or other agents that do not have among their common side effects (\>1%) peripheral neuropathy, will be allowed.