Breast CancerPhase 2NCT04675450
NBP in Women With Metastatic Breast Cancer to Prevent Nab-paclitaxel Induced Toxic Neuropathy
A Phase 2 study testing NBP Softgel Capsules in people with Breast Cancer and Peripheral Neuropathy, run by Conjupro Biotherapeutics, Inc..
Trial summary
Phase 2, randomized, double-blind, Placebo-Controlled, Multiple Dose Study for the treatment of Patients with Metastatic Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Peripheral Neuropathy
- What is being tested?
- NBP Softgel Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2023to 30 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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
- Being tested
- Placebo, NBP Softgel Capsules
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called NBP Placebo 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
NBP Softgel CapsulesDrug
Also called NBP
Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Interventions: Placebo (NBP placebo softgel capsules, 0 mg NBP, BID) Receives: Drug: Placebo |
| NBP | Active comparator | Interventions: 800 mg NBP softgel capsules daily (400 mg BID) Receives: Drug: NBP Softgel Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and weeks 5, 8, 11 and 15
Secondary outcomes (10)
Number of Participants Requiring Rescue Medication
The number and percentage of participants requiring oxycodone of any amount anytime during the 15 week treatment period.
Measured: 15 weeks
Days Free of Rescue Medication
The mean cumulative number of days free of oxycodone of any amount anytime for each participant during the 15 week treatment period.
Measured: 15 weeks
Mean Change from Baseline in the Brief Pain Inventory Short Form (mBPI-SF) score.
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.
Measured: 15 weeks
Number of Participants with Treatment-Emergent Adverse Events
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.
Measured: 19 weeks
Area Under the Curve (AUC) for NBP
The AUC (h*ng/mL) be calculated using Phoenix WinNonlin software
Measured: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
Cmax for NBP
Cmax (ng/mL) be calculated using Phoenix WinNonlin software
Measured: Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
Tmax for NBP
Tmax (hr) be calculated using Phoenix WinNonlin software
Measured: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
Area Under the Curve for Paclitaxel
AUC (h*ng/mL) be calculated using Phoenix WinNonlin software
Measured: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
Cmax for Paclitaxel
Cmax (ng/mL) be calculated using Phoenix WinNonlin software
Measured: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
Tmax for Paclitaxel
Tmax (hr) be calculated using Phoenix WinNonlin software
Measured: Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start30 Jun 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Why it stopped: Further preclinical development activities required to proceed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conjupro Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSPC-NBP Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Qingxi Wang, PhD, Study director, Conjupro Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675450
- Sponsor's protocol ID
- CPO-NBP-2002
- Status last verified
- Jun 2023
- First submitted
- 20 Nov 2020
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04675450
- Acronym / sponsor ID
- CPO-NBP-2002
- Conditions
- Breast Cancer, Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Further preclinical development activities required to proceed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Conjupro Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CSPC-NBP Pharmaceutical Co., Ltd.
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboInterventions: Placebo (NBP placebo softgel capsules, 0 mg NBP, BID) |
| NBP | Active comparator | Drug: NBP Softgel CapsulesInterventions: 800 mg NBP softgel capsules daily (400 mg BID) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: NBP Placebo Softgel CapsulesTake 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing | Drug | Placebo |
| NBP Softgel CapsulesAlso: NBPTake 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 |
Primary outcome
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.
10 secondary outcomes
Number of Participants Requiring Rescue Medication
Time frame: 15 weeks
Days Free of Rescue Medication
Time frame: 15 weeks
Mean Change from Baseline in the Brief Pain Inventory Short Form (mBPI-SF) score.
Time frame: 15 weeks
Number of Participants with Treatment-Emergent Adverse Events
Time frame: 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
Cmax for NBP
Time frame: 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
Area Under the Curve for Paclitaxel
Time frame: 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
Tmax for Paclitaxel
Time frame: Time Frame: 0, 1.5, 3, 4, 6, 8 and 24 hours - Days 6 and 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingxi Wang, PhD study director
Conjupro Biotherapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NBP Softgel Capsules in people with Breast Cancer and Peripheral Neuropathy, run by Conjupro Biotherapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.