NCT04675450

NBP in Women With Metastatic Breast Cancer to Prevent Nab-paclitaxel Induced Toxic Neuropathy

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of n-Butylphthalide (NBP) Softgel Capsules Administered to Patients With Metastatic Breast Cancer to Prevent Nab-paclitaxel Induced Toxic Neuropathy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Conjupro Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Phase 2, randomized, double-blind, Placebo-Controlled, Multiple Dose Study for the treatment of Patients with Metastatic Breast Cancer.

Detailed description

This is a multiple center, randomized, double-blind, Phase 2 study of NBP administered to women with metastatic breast cancer who receive nab-paclitaxel as therapy. Nab-paclitaxel will be administered at a dose \>260 mg/m2 every 3 weeks for 4 planned cycles. Subjects will begin receiving NBP orally at a dose of 400 mg administered every 12-hours (BID) or matching placebo 5 days (10 doses) prior to starting nab-paclitaxel therapy and continue to self-administer it BID until Visit 6/Day 100/Week 15. The primary objective is to evaluate the efficacy of NBP relative to placebo at preventing or reducing symptoms associated with nab-paclitaxel induced toxic neuropathy (CIPN). The secondary objectives include an evaluation the efficacy of NBP relative to placebo at preventing or attenuating taxane induced acute pain syndrome (TAPS), the evaluation of the safety and tolerability of NBP relative to placebo and to determine if NBP administration impacts the pharmacokinetics of nab-paclitaxel or if nab-paclitaxel affects the pharmacokinetics of NBP.

Conditions

• Breast Cancer
• Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Placebo	Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing
DRUG	NBP Softgel Capsules	Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.

Timeline

• Start date: 2023-06-30
• Primary completion: 2024-12-30
• Completion: 2025-01-30
• First posted: 2020-12-19
• Last updated: 2023-06-08

Regulatory

• FDA-regulated drug study