Abstract 1697TiP
Background
CIPN is a common side-effect of multiple anti-neoplastic drugs and approved treatments (Tx) with level 1 evidence are lacking. Management of this adverse event is restricted to dose reductions and Tx interruptions. GTX is a phycotoxin that reversibly binds to the receptor site on the voltage-gated sodium channel of excitable cells, inhibiting the membrane depolarization and consequently conduction of nervous impulse. Initial data indicates that the GTX (topical formulation) improves pain and sensitive symptoms related to peripheral neuropathy secondary to anti-HIV drugs. The aim is to evaluate the effect of GTX on the sensitive symptoms of patients (pts) with grade 2 or higher (G≥2) CIPN.
Trial design
This is a multicenter prospective phase II trial divided in 2 parts (P1 and P2), evaluating the effect of GTX on tactile sensation assessed by Semmens-Weinstein test on pts with CIPN. P1 is a two-stage (S1, S2), two-cohort (C1, C2), open-label study where 38 pts with G≥2 CIPN secondary to taxanes (C1) and other anti-neoplastic drugs (C2) will receive GTX thrice a day for 28 days. Twelve pts will be evaluated in S1, expecting a 20% response (2/12) in each cohort to proceed to S2. Additional 7 pts will be recruited to S2, expecting 4/19 response in each cohort. If the number of responses is not met in a specific cohort, recruitment will be halted. The transition to P2 will be determined by the efficacy in P1 (stratified analysis of C1 and C2 or overall population). Sixty pts with G≥2 CIPN included in P2 will be randomized (1:1) to GTX or placebo. The key exclusion criteria include peripheral neuropathy secondary to other causes (e.g. diabetes) and ongoing systemic Tx with neurotoxic anti-neoplastic drugs. A total of 38 pts will be enrolled in P1 to provide 92% power on the primary endpoint of tactile sensation response and 60 pts will be enrolled in the randomized P2 to provide 83% power on the primary endpoint of tactile sensation response compared to placebo. Secondary endpoints include manipulative dexterity, patient reported symptoms and quality of life evaluation. This trial is currently open and actively recruiting. At the time of the conference we expect P1 recruitment to be completed.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Oncoclínicas do Brasil Serviços Médicos S.A.
Funding
Has not received any funding.
Disclosure
B.L. Ferrari: Non-Financial Interests, Institutional, Stocks/Shares: Oncoclínicas do Brasil Serviços Médicos S.A. C.G.M. Ferreira: Non-Financial Interests, Institutional, Stocks/Shares: Oncoclínicas do Brasil Serviços Médicos S.A. All other authors have declared no conflicts of interest.