Proof of Principle Study Evaluating Gonyautoxins NEURO SERUM, on Chemotherapy-induced Peripheral Neuropathy

NCT05052398 | Unknown Phase 1

• 1 other identifier: Onco-2020
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Evaluate the change in response caused by PSP NEURO SERUM on the tactile sensation from baseline to day 28.

  The response will be assessed using the Semmes-Weinstein monofilament test.

  Screening and day 28

Secondary Outcomes (5)

• Evaluate the change in the overall neurological examination using the Total Neuropathy Score (TNSc), from baseline to day 28.

  Screening and day 28.

• Evaluate the change of manipulative dexterity and agility from baseline to day 28.

  Screening and day 28.

• Evaluate the change in patient reported symptoms from baseline to day 28.

  Screening and day 28.

• Evaluate the appearance of Adverse Events according to NCI-CTCAE v5.0 (National Cancer Institute - Commun Toxicity Criteria For Adverse Events).

  Through the 28 days of the study

• Evaluate the change in the quality of life from baseline to day 28.

  Screening and day 28

Study Arms (2)

PSP NEURO SERUM

ACTIVE COMPARATOR

Active arm in which 26 patients will receive PSP NEURO SERUM in their hands three times a day for 28 days. Each application will consist of 1 g of PSP NEURO SERUM.

Drug: PSP NEURO SERUM

Placebo of PSP NEURO SERUM

PLACEBO COMPARATOR

Placebo arm in which 26 patients will receive Placebo PSP NEURO SERUM (same ingredients as PSP NEURO SERUM except for the active ingredient that is replace with water) in their hands three times a day for 28 days. Each application will consist of 1 g of Placebo PSP NEURO SERUM.

Drug: Placebo PSP NEURO SERUM

Interventions

PSP NEURO SERUM DRUG

PSP NEURO SERUM is a topical product that contains a concentration of Paralytic Shellfish Toxins of 10 micrograms/mL of equivalent of Gonyautoxin 2/3. Each patient will apply 1 g of PSP NEURO SERUM in their hands, three times a day.

PSP NEURO SERUM

Placebo PSP NEURO SERUM DRUG

Placebo PSP NEURO SERUM is the same topical product as PSP NEURO SERUM without the active ingredient. Each patient will apply 1 g of Placebo PSP NEURO SERUM in their hands, three times a day.

Placebo of PSP NEURO SERUM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
• 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.
• 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.
• Patients with grade 2 CIPN with perceived improvement of symptoms.
• Changes in neuropathic pain modulators will not be allowed.
• Any other therapies for chemotherapy-induced peripheral neuropathy must be discontinued at least 2 weeks before the first dose of study drug.
• Known hypersensitivity reaction to PSP Neuro serum.
• Patients with a known or suspected shellfish allergy.
• No dermatologic lesions on hands and feet and cuticles that might increase systemic exposure of the investigational medicinal product (IMP).
• Distal muscle weakness and/or atrophy.

Sponsors & Collaborators

• Algenis SpA: lead
• Oncoclínicas: collaborator

Study Sites (9)

Oncoclínicas Vitória

Vitória, Espírito Santo, 29050-400, Brazil

RECRUITING

Nucleo de Oncologia da Bahia

Salvador, Estado de Bahia, 40.170-110, Brazil

RECRUITING

Oncoclinicas do Brasil Servicios Medicos SA

Belo Horizonte, Minas Gerais, 30.360-680, Brazil

RECRUITING

Centro Oncológico do Triângulo S.A.

Uberlândia, Minas Gerais, 38408-150, Brazil

RECRUITING

Oncoclínicas João Pessoa

João Pessoa, Paraíba, 58030-080, Brazil

RECRUITING

Multihemo

Recife, Pernambuco, 50070-460, Brazil

RECRUITING

Oncoclínicas Florianópolis

Florianópolis, Santa Catarina, 88015-020, Brazil

RECRUITING

Oncoclinicas Rio de Janeiro SA

Rio de Janeiro, 22250-905, Brazil

RECRUITING

Centro de Paulista de Oncologia

São Paulo, 04538-132, Brazil

RECRUITING

Study Officials

• Mariane Fontes, MD

  Oncoclínicas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariane Fontes, MD

CONTACT

+55212127044; mariane.fontes@medicos.oncoclinicas.com

Jorge Canedo, MD

CONTACT

+5511945048150; jorge.canedo@oncoclinicas.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Part 1 is a 2-stage, 2-cohort, open-label study where up to 38 pts with G\>2 CIPN secondary to taxanes and other anti-neoplastic drugs will receive PSP NEURO SERUM (PNS) thrice a day for 28 days. Twelve patients will be evaluated in stage 1, expecting a 20% response per cohort to proceed to stage 2. If needed 7 patients will be recruited, expecting 4/19 response in each cohort. If the number of responses is not met, recruitment will be halted. Part 2 consists of 2 randomized groups of 26 patients each, one control and one experimental group. The population will follow an adaptive approach, considering which cohorts benefited the most from the effects of PNS in Part 1. The 52 patients will be allocated in a 1:1 ratio to Arm A (control) or Arm B with the objective of estimating and comparing the responses of tactile sensitivity using the Semmes-Weinstein monofilament test in hands. Arm A will receive placebo 3 times/day for 28 days, and Arm B will receive PNS 3 times/day for 28 days.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 22, 2021
• Study Start: January 14, 2021
• Primary Completion: July 11, 2024
• Study Completion: July 14, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (9)