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

Phase 2

Withdrawn

• Conditions: Peripheral Neuropathy; Breast Cancer
• Interventions: Drug: Placebo; Drug: NBP Softgel Capsules

• Registration Number: NCT04675450
• Lead Sponsor: Conjupro Biotherapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08
• Study Start: 2023-06-30
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Interventions: Placebo (NBP placebo softgel capsules, 0 mg NBP, BID)
NBP	NBP Softgel Capsules	Interventions: 800 mg NBP softgel capsules daily (400 mg BID)

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline in EORTC Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Sensory Subscale	Baseline and weeks 5, 8, 11 and 15	Change from baseline in the mean EORTC QLQ-CIPN20 sensory subscale (converted to a 0-100 scale) collected during the treatment period at weeks 5, 8, 11 and 15.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Requiring Rescue Medication	15 weeks	The number and percentage of participants requiring oxycodone of any amount anytime during the 15 week treatment period.
Days Free of Rescue Medication	15 weeks	The mean cumulative number of days free of oxycodone of any amount anytime for each participant during the 15 week treatment period.
Mean Change from Baseline in the Brief Pain Inventory Short Form (mBPI-SF) score.	15 weeks	The mean change from baseline (mean days 2-7 after first dose of NBP or Placebo) in the mBPI-SF total score to mean of all post-nab-paclitaxel mBPI-SF scores collected on days 2-7 after each of 4 nab-paclitaxel administration at days 7, 28, 49 and 70 during the 15 week treatment period.
Number of Participants with Treatment-Emergent Adverse Events	19 weeks	The number and percentage of participants with treatment-emergent adverse events according to MedDRA system organ class and preferred term with onset during the 15 week treatment period or 4 week follow-up.
Area Under the Curve (AUC) for NBP	0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7	The AUC (h\*ng/mL) be calculated using Phoenix WinNonlin software
Cmax for NBP	Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7	Cmax (ng/mL) be calculated using Phoenix WinNonlin software
Tmax for NBP	0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7	Tmax (hr) be calculated using Phoenix WinNonlin software
Area Under the Curve for Paclitaxel	0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7	AUC (h\*ng/mL) be calculated using Phoenix WinNonlin software
Cmax for Paclitaxel	0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7	Cmax (ng/mL) be calculated using Phoenix WinNonlin software
Tmax for Paclitaxel	Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7	Tmax (hr) be calculated using Phoenix WinNonlin software