Ignite Creation Date:
2024-05-06 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05052398
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2021-08-10
Brief Title:
Proof of Principle Study Evaluating Gonyautoxins NEURO SERUM on Chemotherapy-induced Peripheral Neuropathy
Sponsor:
Algenis SpA
Organization:
Algenis SpA
Study Overview
Official Title:
Proof of Principle Study Evaluating the Effects of Gonyautoxins Paralytic Shellfish Poisoning PSP NEURO SERUM on Objective and Subjective Symptoms of Chemotherapy-induced Peripheral Neuropathy CINP
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
A multicenter prospective proof-of-concept study in patients with solid tumors who developed chemotherapy-induced peripheral neuropathy CIPN in upper limbs equal or greater than grade 2 according to NCI-CTCAE version 50 Patients must have been treated with cytotoxic agents known to cause CIPN in neoadjuvant adjuvant or palliative setting The primary objective is to assess the effects of gonyautoxins PSP NEURO SERUM on tactile sensitivity and safety on patients with CIPN The study will be divided into two parts 1 and 2 and the investigational treatment will have a maximum duration of 4 weeks 28 days
Part 1 is a two-stage stage 1 and stage 2 two-cohort C1 and C2 open-label study where up to 38 pts with G2 CIPN secondary to taxanes C1 and other anti-neoplastic drugs C2 will receive PSP NEURO SERUM thrice a day for 28 days Twelve patients will be evaluated in stage 1 expecting a 20 response 212 in each cohort to proceed to stage 2 If needed additional 7 patients will be recruited to stage expecting 419 response in each cohort If the number of responses is not met in a specific cohort recruitment will be halted The transition to the randomized part 2 will be determined by the efficacy in part 1 stratified analysis of C1 and C2 or overall population
The primary objective of Part 1 is to evaluate response of the tactile sensation as assessed by the Semmes-Weinstein monofilament test and to evaluate safety and toxicity type frequency grade and causality of adverse effects of PSP NEURO SERUM according to NCI-CTCAE v50
The secondary objectives of Part 1 are to
1 Evaluate the improvement of overall neurological examination as assessed by the clinical version of Total Neuropathy Score TNSc
2 Evaluate the improvement of manipulative dexterity and agility as assessed by the nine-hole pegboard test NHPT
3 Evaluate the improvement in patient reported symptoms as assessed by the Patient Neuropathy Questionnaire PNQ
4 Evaluate the improvement of quality of life by using the Portuguese version of the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire EORTC Quality of Life Questionnaire QLQ-C30 version
A patient will have responded to the CIPN in the study if there is a documented improvement of 30 two sizes of evaluator and or normalization of the baseline pretreatment assessment as assessed by the Semmes-Weinstein monofilament test A patient will have progressed CIPN in the study if there is a documented worsening in tactile sensation assessed by the Semmes-Weinstein monofilament test Worse tactile sensation is defined as the change in one 1 size of the monofilament evaluator
Part 2 of the study consists of two randomized groups of 26 patients each one control group and one experimental group resulting in a total of 52 patients The composition of the study population will follow an adaptive approach considering which cohorts benefited the most from the effects of PSP NEURO SERUM in Part 1 Due to the greater benefit observed in cohort 1 we will proceed in Part 2 with only the population of patients who developed peripheral neuropathy secondary to taxanes
The 52 patients will be allocated in a 11 ratio to either Arm A control n26 or Arm B experimental n26 with the objective of estimating and comparing the responses of tactile sensitivity using the Semmes-Weinstein monofilament test in hands caused by NPIQ Patients in Arm A will receive a placebo topical formulation composed of the same excipients without the active ingredient three times a day for 28 days and patients in Arm B will receive PSP NEURO SERUM topical formulation three times a day for 28 days
This study will follow a two-stage randomized analysis approach with the expectation that the control group will have up to 20 response rate compared to 50 in the experimental group An independent committee will assess and monitor the data collection results allowing or disallowing the continuation of the analysis The first stage will occur when both groups reach 50 of patients with complete validation where a partial evaluation of necessary criteria will take place to proceed with data collection until reaching the required sample size for the final analysis second stage
In Part 2 patients with symptoms in their feet will be offered the possibility of using PSP NEURO SERUMplacebo on their lower limbs The evaluation of symptoms will be assessed by extrapolation based on data collected by the EORTC QLQ CIPN20 Neuropathy Questionnaire
The primary objective of Part 2 is to Evaluate tactile sensitivity response through the monofilament test of Semmes-Weinstein
The secondary objectives of Part 2 are to
1 Evaluate the improvement of overall neurological examination as assessed by the clinical version of Total Neuropathy Score TNSc
2 Evaluate the improvement of manipulative dexterity and agility as assessed by the nine-hole pegboard test NHPT
3 Evaluate the improvement in patient reported symptoms as assessed by the Patient Neuropathy Questionnaire PNQEORTC CIPN20
4 Assess safety and toxicity as per NCI-CTCAE v50 National Cancer Institute - Common Toxicity Criteria For Adverse Events Adverse events will be collected weekly and at the visit of safetmonitoring
5 Evaluate the improvement of quality of life by using the Portuguese version of the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire EORTC Quality of Life Questionnaire QLQ-C30 version
The study procedures include
1 Screening Assessments Part 1 and 2
2 Pre-treatment Baseline Assessments D1 Part 1 and 2
3 D7 1 day - Assessments during Treatment Part 1
4 D14 1 day - Assessments during Treatment Part 1 and 2
5 D21 1 day - Assessments during Treatment Part 1
6 End of Treatment D28 3 days Part 1 and 2
7 Safety Follow-up Visit 30 7 days from the last dose Part 1 and 2
Part 1 is a two-stage stage 1 and stage 2 two-cohort C1 and C2 open-label study where up to 38 pts with G2 CIPN secondary to taxanes C1 and other anti-neoplastic drugs C2 will receive PSP NEURO SERUM thrice a day for 28 days Twelve patients will be evaluated in stage 1 expecting a 20 response 212 in each cohort to proceed to stage 2 If needed additional 7 patients will be recruited to stage expecting 419 response in each cohort If the number of responses is not met in a specific cohort recruitment will be halted The transition to the randomized part 2 will be determined by the efficacy in part 1 stratified analysis of C1 and C2 or overall population
The primary objective of Part 1 is to evaluate response of the tactile sensation as assessed by the Semmes-Weinstein monofilament test and to evaluate safety and toxicity type frequency grade and causality of adverse effects of PSP NEURO SERUM according to NCI-CTCAE v50
The secondary objectives of Part 1 are to
1 Evaluate the improvement of overall neurological examination as assessed by the clinical version of Total Neuropathy Score TNSc
2 Evaluate the improvement of manipulative dexterity and agility as assessed by the nine-hole pegboard test NHPT
3 Evaluate the improvement in patient reported symptoms as assessed by the Patient Neuropathy Questionnaire PNQ
4 Evaluate the improvement of quality of life by using the Portuguese version of the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire EORTC Quality of Life Questionnaire QLQ-C30 version
A patient will have responded to the CIPN in the study if there is a documented improvement of 30 two sizes of evaluator and or normalization of the baseline pretreatment assessment as assessed by the Semmes-Weinstein monofilament test A patient will have progressed CIPN in the study if there is a documented worsening in tactile sensation assessed by the Semmes-Weinstein monofilament test Worse tactile sensation is defined as the change in one 1 size of the monofilament evaluator
Part 2 of the study consists of two randomized groups of 26 patients each one control group and one experimental group resulting in a total of 52 patients The composition of the study population will follow an adaptive approach considering which cohorts benefited the most from the effects of PSP NEURO SERUM in Part 1 Due to the greater benefit observed in cohort 1 we will proceed in Part 2 with only the population of patients who developed peripheral neuropathy secondary to taxanes
The 52 patients will be allocated in a 11 ratio to either Arm A control n26 or Arm B experimental n26 with the objective of estimating and comparing the responses of tactile sensitivity using the Semmes-Weinstein monofilament test in hands caused by NPIQ Patients in Arm A will receive a placebo topical formulation composed of the same excipients without the active ingredient three times a day for 28 days and patients in Arm B will receive PSP NEURO SERUM topical formulation three times a day for 28 days
This study will follow a two-stage randomized analysis approach with the expectation that the control group will have up to 20 response rate compared to 50 in the experimental group An independent committee will assess and monitor the data collection results allowing or disallowing the continuation of the analysis The first stage will occur when both groups reach 50 of patients with complete validation where a partial evaluation of necessary criteria will take place to proceed with data collection until reaching the required sample size for the final analysis second stage
In Part 2 patients with symptoms in their feet will be offered the possibility of using PSP NEURO SERUMplacebo on their lower limbs The evaluation of symptoms will be assessed by extrapolation based on data collected by the EORTC QLQ CIPN20 Neuropathy Questionnaire
The primary objective of Part 2 is to Evaluate tactile sensitivity response through the monofilament test of Semmes-Weinstein
The secondary objectives of Part 2 are to
1 Evaluate the improvement of overall neurological examination as assessed by the clinical version of Total Neuropathy Score TNSc
2 Evaluate the improvement of manipulative dexterity and agility as assessed by the nine-hole pegboard test NHPT
3 Evaluate the improvement in patient reported symptoms as assessed by the Patient Neuropathy Questionnaire PNQEORTC CIPN20
4 Assess safety and toxicity as per NCI-CTCAE v50 National Cancer Institute - Common Toxicity Criteria For Adverse Events Adverse events will be collected weekly and at the visit of safetmonitoring
5 Evaluate the improvement of quality of life by using the Portuguese version of the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire EORTC Quality of Life Questionnaire QLQ-C30 version
The study procedures include
1 Screening Assessments Part 1 and 2
2 Pre-treatment Baseline Assessments D1 Part 1 and 2
3 D7 1 day - Assessments during Treatment Part 1
4 D14 1 day - Assessments during Treatment Part 1 and 2
5 D21 1 day - Assessments during Treatment Part 1
6 End of Treatment D28 3 days Part 1 and 2
7 Safety Follow-up Visit 30 7 days from the last dose Part 1 and 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None