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

NCT04299880 | Completed Phase 1 FDA Drug

• 2 other identifiers: BBI608-9012019-004753-87
• Study Type: interventional
• Target: 7
• Locations: 4 countries
• Sites: 7

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.

Conditions

Oncology

Keywords

Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Pancreatic Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  From first dose until 30 days following last dose of napabucasin

Study Arms (5)

Napabucasin monotherapy

OTHER

Patients in this arm will receive napabucasin administered orally, twice daily

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.

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.

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.

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.

Drug: Napabucasin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5Fluorouracil; Drug: Bevacizumab

Interventions

Napabucasin DRUG

Oral

Also known as: BBI608, BBI-608, BB608

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-paclitaxel DRUG

Intravenous

Also known as: Abraxane

Napabucasin in combination with Gemcitabine and Nab-paclitaxel

Gemcitabine DRUG

Intravenous

Also known as: Gemzar

Napabucasin in combination with Gemcitabine and Nab-paclitaxel

Nivolumab DRUG

Intravenous

Also known as: Opdivo

Napabucasin in combination with Nivolumab

Paclitaxel DRUG

Intravenous

Also known as: Taxol

Napabucasin in combination with paclitaxel

Irinotecan DRUG

Intravenous

Napabucasin in combination with FOLFIRI

Leucovorin DRUG

Intravenous

Napabucasin in combination with FOLFIRI

5Fluorouracil DRUG

Intravenous

Napabucasin in combination with FOLFIRI

Bevacizumab DRUG

Intravenous

Napabucasin in combination with FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (7)

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Maine Center for Cancer Medicine

Scarborough, Maine, 04074, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Centre Antoine Lacassagne

Nice, 06100, France

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

Kyorin University Hospital

Tokyo, 181-8611, Japan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Pancreatic Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Diseases

Interventions

napabucasin; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Nivolumab; Paclitaxel; Irinotecan; Leucovorin; Fluorouracil; Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Individual patients will continue to be treated with napabucasin (monotherapy or combination) in accordance with the parent study under which they were enrolled.

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: February 24, 2020
• Primary Completion: May 15, 2021
• Study Completion: May 30, 2021
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

JP (2); US (3); TW (1); FR (1)