OncologyPhase 1NCT04299880
Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols
A Phase 1 study testing Napabucasin, Nab-paclitaxel and Gemcitabine in people with Oncology, run by Sumitomo Pharma America, Inc. at 7 sites in 4 countries.
Trial summary
This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Napabucasin, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 24 Feb 2020to 30 May 2021
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is currently participating in a BBI-sponsored parent study of napabucasin and must be receiving napabucasin as monotherapy or as part of a combination treatment.
- Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonisation (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
- Must be ≥18 years of age.
- Currently has no evidence of progressive disease, as determined by the investigator, during treatment with napabucasin (either as monotherapy or as part of a combination treatment regimen) or are deriving clinical benefit despite disease progression according to Investigator's clinical judgement.
- Continued ability to swallow and retain orally administered study drug(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test at screening.
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- Non-fertile or agree to use an adequate method of contraception while on study and for 6 months following the last dose and not currently nursing; males agree to use an adequate method of contraception while on study and for 3 months following the last dose (Appendix 3).
- Patients must be accessible for treatment and follow-up. Patients registered on this trial must receive protocol treatment and be followed at their current (parent study) participating center.
- Patient agrees not to participate in other interventional clinical studies during their participation in this trial. Patients participating in surveys or observational studies are eligible to participate in this study.
Who cannot join
- Permanent discontinuation of napabucasin in the parent study.
- Napabucasin dose interruption for >4 weeks between the last dose on the parent study and first dose on the rollover study.
- Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin. Women undergoing combination backbone therapy should not breast feed while on combination backbone therapy and for the period of time following discontinuation of combination backbone therapy as specified in the parent protocol.
- Hypersensitivity to napabucasin or one of the excipients.
- Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
- Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States3 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Maine Center for Cancer Medicine
Scarborough, Maine, 04074
Japan2 sites
Kyorin University Hospital
Tokyo, 181-8611
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
About this study
Official title: A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin Protocols
This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure.
Read the detailed description
This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure. Individual patients will continue to be treated with napabucasin (monotherapy or combination) in accordance with the parent study under which they were enrolled. If the dose was reduced in the parent protocol, the dose of the last visit of the parent study will be used. Patients will be monitored to determine long term safety and tolerability of napabucasin.
- Conditions
- Oncology
- Being tested
- Napabucasin, Nab-paclitaxel, Gemcitabine, Nivolumab, Paclitaxel
- Keywords
- Neoplasms, Neoplasms by Site, Digestive System Neoplasms, Pancreatic Neoplasms, Adenocarcinoma, Neoplasms, Glandular and Epithelial, Digestive System Diseases
- Medical subject headings
- Neoplasms, Neoplasms by Site, Digestive System Neoplasms, Pancreatic Neoplasms, Adenocarcinoma, Neoplasms, Glandular and Epithelial, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NapabucasinDrug
Also called BBI608, BBI-608, BB608
Oral
Nab-paclitaxelDrug
Also called Abraxane
Intravenous
GemcitabineDrug
Also called Gemzar
Intravenous
NivolumabDrug
Also called Opdivo
Intravenous
PaclitaxelDrug
Also called Taxol
Intravenous
IrinotecanDrug
Intravenous
LeucovorinDrug
Intravenous
5FluorouracilDrug
Intravenous
BevacizumabDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Napabucasin monotherapy | Other | Patients in this arm will receive napabucasin administered orally, twice daily Receives: Drug: Napabucasin |
| Napabucasin in combination with Gemcitabine and Nab-paclitaxel | Other | Patients in this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously once weekly, on 3 of every 4 weeks. Receives: Drug: Napabucasin; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| Napabucasin in combination with Nivolumab | Other | Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly nivolumab 3mg/kg administered intravenously over 60 minutes. Receives: Drug: Napabucasin; Drug: Nivolumab |
| Napabucasin in combination with paclitaxel | Other | Patients in this arm will receive napabucasin administered orally, twice daily in combination with weekly paclitaxel administered intravenously once weekly, on 3 of every 4 weeks. Receives: Drug: Napabucasin; Drug: Paclitaxel |
| Napabucasin in combination with FOLFIRI | Other | Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly FOLFIRI. Addition of bevacizumab, per Investigator choice, will be permissible. Receives: Drug: Napabucasin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5Fluorouracil; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events, including clinically significant laboratory abnormalities, as characterized by type, frequency, severity (as graded by NCI CTCAE version 4.0), seriousness, and relationship to study therapy.
Measured: From first dose until 30 days following last dose of napabucasin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start24 Feb 2020
- Primary completion15 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Individual patients will continue to be treated with napabucasin (monotherapy or combination) in accordance with the parent study under which they were enrolled.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299880
- Sponsor's protocol ID
- BBI608-901
- Other IDs
- 2019-004753-87, 2019
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2020
- Last updated
- 8 Nov 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 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin Protocols
- ClinicalTrials.gov ID
- NCT04299880
- Acronym / sponsor ID
- BBI608-901
- Conditions
- Oncology
- Keywords
- Neoplasms, Neoplasms by Site, Digestive System Neoplasms, Pancreatic Neoplasms, Adenocarcinoma, Neoplasms, Glandular and Epithelial, Digestive System Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 9 Mar 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.
This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure.
Detailed description
This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure. Individual patients will continue to be treated with napabucasin (monotherapy or combination) in accordance with the parent study under which they were enrolled. If the dose was reduced in the parent protocol, the dose of the last visit of the parent study will be used. Patients will be monitored to determine long term safety and tolerability of napabucasin.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Individual patients will continue to be treated with napabucasin (monotherapy or combination) in accordance with the parent study under which they were enrolled.
| Arm | Type | Receives |
|---|---|---|
| Napabucasin monotherapy | Other | Drug: NapabucasinPatients in this arm will receive napabucasin administered orally, twice daily |
| Napabucasin in combination with Gemcitabine and Nab-paclitaxel | Other | Drug: Napabucasin, Drug: Nab-paclitaxel, Drug: GemcitabinePatients in this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously once weekly, on 3 of every 4 weeks. |
| Napabucasin in combination with Nivolumab | Other | Drug: Napabucasin, Drug: NivolumabPatients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly nivolumab 3mg/kg administered intravenously over 60 minutes. |
| Napabucasin in combination with paclitaxel | Other | Drug: Napabucasin, Drug: PaclitaxelPatients in this arm will receive napabucasin administered orally, twice daily in combination with weekly paclitaxel administered intravenously once weekly, on 3 of every 4 weeks. |
| Napabucasin in combination with FOLFIRI | Other | Drug: Napabucasin, Drug: Irinotecan, Drug: Leucovorin, Drug: 5Fluorouracil, Drug: BevacizumabPatients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly FOLFIRI. Addition of bevacizumab, per Investigator choice, will be permissible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient is currently participating in a BBI-sponsored parent study of napabucasin and must be receiving napabucasin as monotherapy or as part of a combination treatment.
- Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonisation (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure.
- Must be ≥18 years of age.
- Currently has no evidence of progressive disease, as determined by the investigator, during treatment with napabucasin (either as monotherapy or as part of a combination treatment regimen) or are deriving clinical benefit despite disease progression according to Investigator's clinical judgement.
- Continued ability to swallow and retain orally administered study drug(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome.
Key exclusion criteria (6 listed)
- Permanent discontinuation of napabucasin in the parent study.
- Napabucasin dose interruption for >4 weeks between the last dose on the parent study and first dose on the rollover study.
- Women who are pregnant or breastfeeding. Women should not breastfeed while taking study treatment and for 4 weeks after the last dose of napabucasin. Women undergoing combination backbone therapy should not breast feed while on combination backbone therapy and for the period of time following discontinuation of combination backbone therapy as specified in the parent protocol.
- Hypersensitivity to napabucasin or one of the excipients.
- Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
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 |
|---|---|---|
| NapabucasinAlso: BBI608, BBI-608, BB608Oral | Drug | Napabucasin in combination with FOLFIRI, Napabucasin in combination with Gemcitabine and Nab-paclitaxel, Napabucasin in combination with Nivolumab, Napabucasin in combination with paclitaxel, Napabucasin monotherapy |
| Nab-paclitaxelAlso: AbraxaneIntravenous | Drug | Napabucasin in combination with Gemcitabine and Nab-paclitaxel |
| GemcitabineAlso: GemzarIntravenous | Drug | Napabucasin in combination with Gemcitabine and Nab-paclitaxel |
| NivolumabAlso: OpdivoIntravenous | Drug | Napabucasin in combination with Nivolumab |
| PaclitaxelAlso: TaxolIntravenous | Drug | Napabucasin in combination with paclitaxel |
| IrinotecanIntravenous | Drug | Napabucasin in combination with FOLFIRI |
| LeucovorinIntravenous | Drug | Napabucasin in combination with FOLFIRI |
| 5FluorouracilIntravenous | Drug | Napabucasin in combination with FOLFIRI |
| BevacizumabIntravenous | Drug | Napabucasin in combination with FOLFIRI |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From first dose until 30 days following last dose of napabucasin
Adverse Events, including clinically significant laboratory abnormalities, as characterized by type, frequency, severity (as graded by NCI CTCAE version 4.0), seriousness, and relationship to study therapy.
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 8 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Napabucasin, Nab-paclitaxel and Gemcitabine in people with Oncology, run by Sumitomo Pharma America, Inc. at 7 sites in 4 countries.
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 9 inclusion and 6 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Japan, France, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From first dose until 30 days following last dose of napabucasin). 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 Nov 2023.