Breast NeoplasmsPhase 3NCT00039780
Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel
A Phase 3 study testing BNP7787 in people with Breast Neoplasms and Breast Diseases, run by BioNumerik Pharmaceuticals, Inc..
Trial summary
The purpose of this study is to determine whether BNP7787 is effective in preventing or reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Diseases, Metastases, Neoplasm
- What is being tested?
- BNP7787
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 764 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Sep 2014
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented metastatic breast cancer
- Measurable disease
- Performance Status; ECOG 0-2
- More than 2 weeks since prior radiation therapy
- 14 days or more since prior therapy and recovered from all side effects
- For patients who progress while receiving hormonal therapy alone, the patient may be enrolled on study as soon as they have recovered from all side effects of the hormonal therapy
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- Clinical laboratory values must meet the following:
- Granulocytes greater than or equal to 1,500/mm(3)
- Platelets greater than or equal to 100,000/mm(3)
- Hemoglobin greater than or equal to 9 g/dL
- SGOT less than 2.0 x ULN
- Bilirubin less than or equal to 1.5 mg/dL
- Creatinine less than or equal to 1.6 mg/dL
- Calcium less than the ULN
Who cannot join
- Current CNS metastases or history of CNS metastases
- History of diabetes (Type I or Type II)
- Previous or concurrent malignancy except:
- inactive non-melanoma skin cancer
- in situ carcinoma of the cervix
- or other cancer if the patient has been disease-free for more than 5 years
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- Pregnant or lactating women
- History of recent myocardial infarction, stroke, or uncontrolled CHF, epilepsy, or hypertension
- Patients currently receiving Neurontin® (gabapentin), glutamine supplements, Elavil® (amitriptyline), Dilantin®, Tegretol®, tricyclic antidepressants or other similar medications during the study period
- Alternative medications including megadose vitamins, herbal preparations, tonics, extracts, etc. are not allowed during the study period.
About this study
Official title: BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer
The purpose of this study is to determine whether BNP7787 is effective in preventing or reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®).
Read the detailed description
Chemotherapy induced toxicities are common and serious problems for many patients who receive treatment for cancer. Chemotherapy induced toxicities can adversely impact the quality of life and the ability of patients to continue treatment for their cancer. One such toxicity associated with the use of paclitaxel (Taxol®) is peripheral neurotoxicity.
Paclitaxel is an active drug in the treatment of metastatic breast cancer as first-line treatment and in patients with recurrent or refractory disease, including patients who have failed to respond to previous anthracycline therapy. Recent studies with paclitaxel using a weekly schedule of administration have demonstrated higher tumor response rates and disease free survival accompanied by a shift in the frequency of certain toxicities, increased dose intensity and a potential means to improve the treatment schedule of paclitaxel for improved patient benefit.
Paclitaxel induced neurotoxicity remains an important problem that limits the ability to improve the schedule of administration of this drug. To date, there is no effective or FDA approved therapy to prevent the development of or reduce the frequency or severity of paclitaxel-induced neurotoxicity.
BNP7787 is an investigational new drug that is undergoing development for chemoprotection of platinum and taxane associated common clinical toxicities, particularly the prevention of chemotherapy-induced neurotoxicity.
In this Phase 3 clinical trial the safety and effectiveness of BNP7787 in preventing or mitigating the frequency, severity, worsening of grade, time to onset, duration and discontinuation of therapy due to paclitaxel-induced neurotoxicity will be assessed in patients with metastatic breast cancer.
- Conditions
- Breast Neoplasms, Breast Diseases, Metastases, Neoplasm
- Being tested
- BNP7787, Placebo
- Keywords
- Breast, Cancer, Metastatic, Paclitaxel, Peripheral, Taxol, Neuropathy, Neurotoxicity, Paresthesias, Weekly, BNP7787, 7787, Tavocept, Prevention
- Medical subject headings
- Breast Neoplasms, Breast Diseases, Neoplasm Metastasis, Neoplasms, Neurotoxicity Syndromes, Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNP7787Drug
Also called BNP7787 also known as Tavocept
The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
PlaceboDrug
The treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Tavocept (BNP7787) Receives: Drug: BNP7787 |
| 2 | Placebo comparator | 0.9% Sodium Chloride Soln. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1)Incidence of PNQ Grade D or Grade E neurosensory symptoms (Item 1 of the PNQ) with duration of at least 4 weks; 2) Objective tumor response rate
Measured: baseline to disease progression or discontinuation from study
Secondary outcomes (4)
Incidence of Dose Modifications, Treatment Delays and Treatment Discontinuations due to Neurotoxicity
Measured: baseline to end of treatment
Time-to-onset of clinically important neurotoxicity
Measured: randomization to date of first occurrence of clinically important neurotoxicity
Incidence of Neurosensory and Neuromotor Functional Impairment
Measured: baseline through end of treatment
Progression Free Survival
Measured: Randomization to disease progression or death due to any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2002 (estimated)
- Study startSep 2001
- Primary completionOct 2006
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNumerik Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039780
- Sponsor's protocol ID
- DMS30203R
- Status last verified
- Jul 2022
- First submitted
- 10 Jun 2002
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BNP7787 vs. Placebo for Prevention of Paclitaxel Neurotoxicity: A Double-Blind Multicenter Randomized Phase 3 Trial in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00039780
- Acronym / sponsor ID
- DMS30203R
- Conditions
- Breast Neoplasms, Breast Diseases, Metastases, Neoplasm
- Keywords
- Breast, Cancer, Metastatic, Paclitaxel, Peripheral, Taxol, Neuropathy, Neurotoxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- BioNumerik Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.
- Study start
- Sep 2001
- Primary completion
- Oct 2006 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Jun 2002 (estimated)
- 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.
The purpose of this study is to determine whether BNP7787 is effective in preventing or reducing neurotoxicity (nerve damage) caused by paclitaxel (Taxol®).
Detailed description
Chemotherapy induced toxicities are common and serious problems for many patients who receive treatment for cancer. Chemotherapy induced toxicities can adversely impact the quality of life and the ability of patients to continue treatment for their cancer. One such toxicity associated with the use of paclitaxel (Taxol®) is peripheral neurotoxicity.
Paclitaxel is an active drug in the treatment of metastatic breast cancer as first-line treatment and in patients with recurrent or refractory disease, including patients who have failed to respond to previous anthracycline therapy. Recent studies with paclitaxel using a weekly schedule of administration have demonstrated higher tumor response rates and disease free survival accompanied by a shift in the frequency of certain toxicities, increased dose intensity and a potential means to improve the treatment schedule of paclitaxel for improved patient benefit.
Paclitaxel induced neurotoxicity remains an important problem that limits the ability to improve the schedule of administration of this drug. To date, there is no effective or FDA approved therapy to prevent the development of or reduce the frequency or severity of paclitaxel-induced neurotoxicity.
BNP7787 is an investigational new drug that is undergoing development for chemoprotection of platinum and taxane associated common clinical toxicities, particularly the prevention of chemotherapy-induced neurotoxicity.
In this Phase 3 clinical trial the safety and effectiveness of BNP7787 in preventing or mitigating the frequency, severity, worsening of grade, time to onset, duration and discontinuation of therapy due to paclitaxel-induced neurotoxicity will be assessed in patients with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: BNP7787Tavocept (BNP7787) |
| 2 | Placebo comparator | Drug: Placebo0.9% Sodium Chloride Soln. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically documented metastatic breast cancer
- Measurable disease
- Performance Status; ECOG 0-2
- More than 2 weeks since prior radiation therapy
- 14 days or more since prior therapy and recovered from all side effects
Key exclusion criteria (10 listed)
- Current CNS metastases or history of CNS metastases
- History of diabetes (Type I or Type II)
- inactive non-melanoma skin cancer
- in situ carcinoma of the cervix
- or other cancer if the patient has been disease-free for more than 5 years
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 |
|---|---|---|
| BNP7787Also: BNP7787 also known as TavoceptThe treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks. | Drug | 1 |
| PlaceboThe treatment regimen administered in this study is a single IV doxe of paclitaxel (80 mg/m2) +/- Herceptin given over 1 hour and either BNP7787 (18.4 g/m2) or placebo given over 45 minutes each week. One treatment cycle = 8 weeks. | Drug | 2 |
Primary outcome
1)Incidence of PNQ Grade D or Grade E neurosensory symptoms (Item 1 of the PNQ) with duration of at least 4 weks; 2) Objective tumor response rate
Time frame: baseline to disease progression or discontinuation from study
4 secondary outcomes
Incidence of Dose Modifications, Treatment Delays and Treatment Discontinuations due to Neurotoxicity
Time frame: baseline to end of treatment
Time-to-onset of clinically important neurotoxicity
Time frame: randomization to date of first occurrence of clinically important neurotoxicity
Incidence of Neurosensory and Neuromotor Functional Impairment
Time frame: baseline through end of treatment
Progression Free Survival
Time frame: Randomization to disease progression or death due to any cause
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BNP7787 in people with Breast Neoplasms and Breast Diseases, run by BioNumerik Pharmaceuticals, 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 14 inclusion and 10 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: finished, as of the sponsor's last update on 13 Jul 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1)Incidence of PNQ Grade D or Grade E neurosensory symptoms (Item 1 of the PNQ) with duration of at least 4 weks; 2) Objective tumor response rate (time frame: baseline to disease progression or discontinuation from study). 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 13 Jul 2022.