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This is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.
TAS-120-404 is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.
Patients who are still receiving futibatinib as monotherapy or as combination therapy, are deriving clinical benefit with no undue risk as assessed by the investigator, and have not met any of the antecedent protocol-specific discontinuation criteria are eligible to participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS-120 (futibatinib) monotherapy | Experimental | TAS-120 tablets, oral, cycle length is defined as per antecedent study design |
|
| TAS-120 (futibatinib) combination therapy with fulvestrant | Experimental | TAS-120 tablets in combination with fulvestrant, oral, cycle length is defined as per antecedent study design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| futibatinib | Drug | TAS-120 futibatinib monotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0. | To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with fulvestrant who participated in a Taiho-sponsored futibatinib study and who are deriving clinical benefit with no undue risk | through study completion, an average of 5 years |
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Inclusion Criteria:
Exclusion Criteria:
• Has met any discontinuation criteria within the antecedent futibatinib study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco (UCSF) | San Francisco | California | 94143 | United States | ||
| Institut Paoli-Calmettes |
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| futibatinib, fulvestrant | Drug | TAS-120 futibatinib combination therapy with fulvestrant |
|
|
| Marseille |
| 13009 |
| France |
| Institut De Cancerologie Strasbourg | Strasbourg | 67033 | France |
| Severance Hospital | Seoul | 3722 | South Korea |
| Hospital Universitari, Vall d'Hebron | Barcelona | 8035 | Spain |
| Centro Integral Oncologico | Madrid | 28050 | Spain |
| Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| Sarah Cannon Research Institute UK | London | W1G 6AD | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | W1T 7HA | United Kingdom |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000713257 | futibatinib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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