- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04675450
NBP in Women With Metastatic Breast Cancer to Prevent Nab-paclitaxel Induced Toxic Neuropathy
June 7, 2023 updated by: Conjupro Biotherapeutics, Inc.
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
Phase 2, randomized, double-blind, Placebo-Controlled, Multiple Dose Study for the treatment of Patients with Metastatic Breast Cancer.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Audrey Li
- Phone Number: 609-356-0210
- Email: clinicaltrials.gov@cspcus.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
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.
- Able to comply with all study requirements. Exclusion Criteria
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.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level >2.0 x upper limits of normal (ULN), or a bilirubin >1.5 x ULN unless in the setting of known Gilbert's disease at Screening.
- History of HIV, hepatitis B, hepatitis C, or tuberculosis.
- Major surgical procedures ≤30 days prior to starting study drug, or minor surgical procedures ≤7 days prior to starting study drug.
- History of alcohol or drug dependence or is known to have abused alcohol within 30 days prior to screening.
- Unwilling to abstain from alcohol and recreational drugs (with exception for medical marijuana) throughout the duration of participation in the study.
- Positive urine drug screen at Screening (with exception for medical marijuana which is allowed).
- Known hypersensitivity to celery or soybeans.
- Known serious hypersensitivity to paclitaxel
- Received treatment with any other investigational drug within 30 days before screening, was previously treated with NBP, is currently taking celery seed extract, or is currently participating in another clinical study
- Any other reasons that in the opinion of the investigator make the subject unsuitable for enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Interventions: Placebo (NBP placebo softgel capsules, 0 mg NBP, BID)
|
Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing
Other Names:
|
Active Comparator: NBP
Interventions: 800 mg NBP softgel capsules daily (400 mg BID)
|
Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change from Baseline in EORTC Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Sensory Subscale
Time Frame: 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.
|
Baseline and weeks 5, 8, 11 and 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Requiring Rescue Medication
Time Frame: 15 weeks
|
The number and percentage of participants requiring oxycodone of any amount anytime during the 15 week treatment period.
|
15 weeks
|
Days Free of Rescue Medication
Time Frame: 15 weeks
|
The mean cumulative number of days free of oxycodone of any amount anytime for each participant during the 15 week treatment period.
|
15 weeks
|
Mean Change from Baseline in the Brief Pain Inventory Short Form (mBPI-SF) score.
Time Frame: 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.
|
15 weeks
|
Number of Participants with Treatment-Emergent Adverse Events
Time Frame: 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.
|
19 weeks
|
Area Under the Curve (AUC) for NBP
Time Frame: 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
|
0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
|
Cmax for NBP
Time Frame: 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
|
Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
|
Tmax for NBP
Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
|
Tmax (hr) be calculated using Phoenix WinNonlin software
|
0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
|
Area Under the Curve for Paclitaxel
Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
|
AUC (h*ng/mL) be calculated using Phoenix WinNonlin software
|
0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
|
Cmax for Paclitaxel
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
|
0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
|
Tmax for Paclitaxel
Time Frame: Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
|
Tmax (hr) be calculated using Phoenix WinNonlin software
|
Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Qingxi Wang, PhD, Conjupro Biotherapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 30, 2023
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
January 30, 2025
Study Registration Dates
First Submitted
November 20, 2020
First Submitted That Met QC Criteria
December 14, 2020
First Posted (Actual)
December 19, 2020
Study Record Updates
Last Update Posted (Actual)
June 8, 2023
Last Update Submitted That Met QC Criteria
June 7, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPO-NBP-2002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States