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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004753-87 | EudraCT Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Napabucasin monotherapy | Other | Patients in this arm will receive napabucasin administered orally, twice daily |
|
| 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. |
|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Napabucasin | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States | ||
| Maine Center for Cancer Medicine |
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Individual patients will continue to be treated with napabucasin (monotherapy or combination) in accordance with the parent study under which they were enrolled.
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|
|
| Nab-paclitaxel | Drug | Intravenous |
|
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| Gemcitabine | Drug | Intravenous |
|
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| Nivolumab | Drug | Intravenous |
|
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| Paclitaxel | Drug | Intravenous |
|
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| Irinotecan | Drug | Intravenous |
|
| Leucovorin | Drug | Intravenous |
|
| 5Fluorouracil | Drug | Intravenous |
|
| Bevacizumab | Drug | Intravenous |
|
| Scarborough |
| Maine |
| 04074 |
| United States |
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| Centre Antoine Lacassagne | Nice | 06100 | France |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Kyorin University Hospital | Tokyo | 181-8611 | Japan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D004067 | Digestive System Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002277 | Carcinoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000621033 | napabucasin |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000093542 | Gemcitabine |
| D000077594 | Nivolumab |
| D017239 | Paclitaxel |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
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