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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509318-13-00 | Registry Identifier | EU CT Number |
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This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabrafenib monotherapy | Experimental | Patients in this study may receive: - monotherapy of dabrafenib |
|
| trametinib monotherapy | Experimental | Patients in this study may receive: - monotherapy of trametinib |
|
| Combination therapy (dabrafenib & trametinib) | Experimental | Patients in this study may receive: - the combination of dabrafenib and trametinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabrafenib | Drug | dabrafenib is available in capsules (50mg and 75mg) taken twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination | Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event. | Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Assessment by investigator | To evaluate clinical benefit as assessed by the Investigator | Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health Research Institute | Active, not recruiting | Scottsdale | Arizona | 85258 | United States | |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| trametinib | Drug | trametinib is available in tablets (0.5mg, 2mg dose) |
|
| National Institute Of Health |
| Active, not recruiting |
| Bethesda |
| Maryland |
| 20892 |
| United States |
| James Cancer Hospital and Solove Research Institute Ohio State | Completed | Columbus | Ohio | 43210 | United States |
| Mary Crowley Cancer Research | Completed | Dallas | Texas | 75251 | United States |
| Novartis Investigative Site | Completed | Caba | Buenos Aires | C1121ABE | Argentina |
| Novartis Investigative Site | Active, not recruiting | Innsbruck | Tyrol | 6020 | Austria |
| Novartis Investigative Site | Completed | Beijing | 100036 | China |
| Novartis Investigative Site | Active, not recruiting | Copenhagen | DK-2100 | Denmark |
| Novartis Investigative Site | Active, not recruiting | Lyon | 69373 | France |
| Novartis Investigative Site | Active, not recruiting | Nantes | 44093 | France |
| Novartis Investigative Site | Recruiting | Paris | 75231 | France |
| Novartis Investigative Site | Completed | Paris | 75970 | France |
| Novartis Investigative Site | Completed | Villejuif | 94800 | France |
| Novartis Investigative Site | Completed | Mannheim | Baden-Wurttemberg | 68305 | Germany |
| Novartis Investigative Site | Completed | Berlin | 13353 | Germany |
| Novartis Investigative Site | Recruiting | Essen | 45147 | Germany |
| Novartis Investigative Site | Completed | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Recruiting | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Active, not recruiting | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Completed | Debrecen | Hajdu Bihar Megye | 4032 | Hungary |
| Novartis Investigative Site | Completed | Budapest | H 1122 | Hungary |
| Novartis Investigative Site | Completed | Kashiwa | Chiba | 277-8577 | Japan |
| Novartis Investigative Site | Completed | Chuo Ku | Tokyo | 1040045 | Japan |
| Novartis Investigative Site | Completed | Rotterdam | South Holland | 3015 GD | Netherlands |
| Novartis Investigative Site | Active, not recruiting | Utrecht | 3584 CX | Netherlands |
| Novartis Investigative Site | Recruiting | Barcelona | 08035 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28009 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28040 | Spain |
| Novartis Investigative Site | Completed | Madrid | 28041 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28050 | Spain |
| Novartis Investigative Site | Recruiting | Valencia | 46026 | Spain |
| Novartis Investigative Site | Active, not recruiting | Songkhla | Hat Yai | 90110 | Thailand |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D005910 | Glioma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| C561627 | dabrafenib |
| C560077 | trametinib |
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