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

NCT04675450 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: CPO-NBP-2002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Cancer; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in EORTC Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Sensory Subscale

  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.

  Baseline and weeks 5, 8, 11 and 15

Secondary Outcomes (10)

• Number of Participants Requiring Rescue Medication

  15 weeks

• Days Free of Rescue Medication

  15 weeks

• Mean Change from Baseline in the Brief Pain Inventory Short Form (mBPI-SF) score.

  15 weeks

• Number of Participants with Treatment-Emergent Adverse Events

  19 weeks

• Area Under the Curve (AUC) for NBP

  0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Interventions: Placebo (NBP placebo softgel capsules, 0 mg NBP, BID)

Drug: Placebo

NBP

ACTIVE COMPARATOR

Interventions: 800 mg NBP softgel capsules daily (400 mg BID)

Drug: NBP Softgel Capsules

Interventions

Placebo DRUG

Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing

Also known as: NBP Placebo Softgel Capsules

Placebo

NBP Softgel Capsules DRUG

Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.

Also known as: NBP

NBP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are eligible to participate in the study only if all the following criteria apply:
• Women aged ≥18 and ≤75 years.
• Pathologically confirmed metastatic breast cancer.
• Are candidates for initial therapy with nab-paclitaxel, at a dose of \>260 mg/m2 every 3 weeks for 4 planned cycles.
• Concomitant antitumor drugs used to treat the underlying malignancy, including immunotherapies, other than nab-paclitaxel will be allowed.
• Eastern Cooperative Oncology Group (ECOG) performance status scores of 0 - 2.
• Life expectancy ≥6 months.
• Women of childbearing potential (WOCBP) must have a negative serum human chorionic gonadotropin (HCG) pregnancy test at Screening and be practicing a medically acceptable method of contraception with an annual failure rate of less than 1% until the completion of the trial or 30 days after discontinuation of study treatment. Women are considered not childbearing if they are \>1 year postmenopausal or surgically sterile (ie, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy tubal ligation).
• Able to complete study questionnaires by themselves or with assistance.
• Capable of understanding the purpose and risks of the study and able to provide informed consent by signing the informed consent form.
• Able to swallow softgel capsules as determined by the investigator.

You may not qualify if:

• Subjects are excluded from the study if any of the following criteria apply:
• Non-metastatic breast cancer.
• Subjects who are pregnant, lactating/breast-feeding, or plan to become pregnant within the next 3 months.
• History of poorly controlled diabetes mellitus (hemoglobin A1C \>8.0 at the time of the Screening visit).
• History of fibromyalgia.
• History of any signs or symptoms suggestive of neuropathy within 30 days of Screening as determined by the investigator based on the neurological examination.
• History of taking any neurotoxic drugs within 6 months of Screening.
• Current use of drugs that are used to treat neuropathic pain (eg, gabapentin, pregabalin, and duloxetine) within 30 days of Screening.
• Current diagnosis of malignancy other than breast cancer.
• Absolute neutrophil count \<1.5 x 109 cells/L.
• Platelet count \<100,000 x 109/L.
• Hemoglobin level \<9 g/dL at Screening without transfusion (transfusion independent).
• Corrected QTcF \>470 msec (single tracing) at Screening and prior to randomization.
• Chronic renal or hepatic disease.
• Clinically significant renal dysfunction including serum creatinine level \>1.5 mg/dL or calculated creatinine clearance ≥50 mL/minute at Screening.

Sponsors & Collaborators

• Conjupro Biotherapeutics, Inc.: lead
• CSPC-NBP Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Qingxi Wang, PhD

  Conjupro Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 19, 2020
• Study Start: June 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: June 8, 2023

Record last verified: 2023-06