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Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04299880
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Oncology, Inc

Brief 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 benefit in the parent study at the time of closure.

Condition or disease Intervention/treatment Phase
Oncology Drug: Napabucasin Drug: Nab-paclitaxel Drug: Gemcitabine Drug: Nivolumab Drug: Paclitaxel Drug: Irinotecan Drug: Leucovorin Drug: 5Fluorouracil Drug: Bevacizumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: A Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Napabucasin Protocols
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Napabucasin monotherapy
Patients in this arm will receive napabucasin administered orally, twice daily
Drug: Napabucasin
Oral
Other Names:
  • BBI608
  • BBI-608
  • BB608

Napabucasin in combination with Gemcitabine and Nab-paclitaxel
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.
Drug: Napabucasin
Oral
Other Names:
  • BBI608
  • BBI-608
  • BB608

Drug: Nab-paclitaxel
Intravenous
Other Name: Abraxane

Drug: Gemcitabine
Intravenous
Other Name: Gemzar

Napabucasin in combination with Nivolumab
Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly nivolumab 3mg/kg administered intravenously over 60 minutes.
Drug: Napabucasin
Oral
Other Names:
  • BBI608
  • BBI-608
  • BB608

Drug: Nivolumab
Intravenous
Other Name: Opdivo

Napabucasin in combination with paclitaxel
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.
Drug: Napabucasin
Oral
Other Names:
  • BBI608
  • BBI-608
  • BB608

Drug: Paclitaxel
Intravenous
Other Name: Taxol

Napabucasin in combination with FOLFIRI
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.
Drug: Napabucasin
Oral
Other Names:
  • BBI608
  • BBI-608
  • BB608

Drug: Irinotecan
Intravenous

Drug: Leucovorin
Intravenous

Drug: 5Fluorouracil
Intravenous

Drug: Bevacizumab
Intravenous




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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.
  2. 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.
  3. Must be ≥18 years of age.
  4. 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.
  5. 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.
  6. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test at screening.
  7. 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).
  8. 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.
  9. 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.

Exclusion Criteria

  1. Permanent discontinuation of napabucasin in the parent study.
  2. Napabucasin dose interruption for >4 weeks between the last dose on the parent study and first dose on the rollover study.
  3. 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.
  4. Hypersensitivity to napabucasin or one of the excipients.
  5. Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
  6. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299880


Locations
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United States, Maine
Maine Center for Cancer Medicine
Scarborough, Maine, United States, 04074
Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Kyorin University Hospital
Tokyo, Japan, 181-8611
Sponsors and Collaborators
Sumitomo Dainippon Pharma Oncology, Inc
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Responsible Party: Sumitomo Dainippon Pharma Oncology, Inc
ClinicalTrials.gov Identifier: NCT04299880    
Other Study ID Numbers: BBI608-901
2019-004753-87 ( EudraCT Number )
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sumitomo Dainippon Pharma Oncology, Inc:
Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Pancreatic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Digestive System Diseases
Additional relevant MeSH terms:
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Neoplasms
Leucovorin
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Fluorouracil
Irinotecan
Nivolumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors