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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004793-26 | EudraCT Number |
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The preliminary data does not suggest any safety signal, but an ad hoc interim analysis showed an imbalance of PFS between the two arms
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| Name | Class |
|---|---|
| Taiho Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on survival, how much time may pass without disease progression, and the safety of TAS-102.
This is a multicenter, open-label, two-arm, randomized Phase 2 study of TAS-102 versus Investigator's choice of therapy in patients requiring second-line chemotherapy for SCLC refractory or sensitive to first-line platinum-based chemotherapy. Investigator's choice of therapy is defined as second-line chemotherapy with IV topotecan (Europe/Japan) or IV amrubicin (Japan). Patients will be stratified by response to first-line platinum-based chemotherapy (sensitive vs refractory). Sensitive patients are defined as patients who did not progress within 90 days after the last dose, and refractory patients are defined as patients who never responded or who responded but had radiologic progression < 90 days after the last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS-102 | Experimental |
| |
| Investigator Choice of Amrubicin or Topotecan | Active Comparator | Investigator Choice of Amrubicin (Japan only) or Topotecan (Europe and Japan) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS-102 | Drug | 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Tumor assessments will be performed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 every 6 weeks during study treatment, and every 8 weeks after treatment is completed. Tumor assessments will be performed from Day 1, Cycle 1 until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met. | Every 6 weeks from the start of study treatment (Day 1, Cycle 1). Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Survival status will be collected at 8-week intervals until death, for up to 12 months after the first dose of study medication for the last patient randomized or until the target number of events (deaths) is met, whichever is later. | |
| Safety monitoring including adverse events, vital signs, and laboratory assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giorgio Scagliotti, MD | University of Turin San Luigi Hospital | Principal Investigator |
| Kaoru Kubota, MD, PhD | Nippon Medical School Hospital Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Mannheim GmbH Universitaetsklinikum | Mannheim | Baden-Wurttemberg | Germany | |||
| Lungenklinik Heckeshorn- HELIOS Kliniken GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27597276 | Derived | Scagliotti G, Nishio M, Satouchi M, Valmadre G, Niho S, Galetta D, Cortinovis D, Benedetti F, Yoshihara E, Makris L, Inoue A, Kubota K. A phase 2 randomized study of TAS-102 versus topotecan or amrubicin in patients requiring second-line chemotherapy for small cell lung cancer refractory or sensitive to frontline platinum-based chemotherapy. Lung Cancer. 2016 Oct;100:20-23. doi: 10.1016/j.lungcan.2016.06.023. Epub 2016 Jun 27. |
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| Amrubicin (Japan) | Drug | Patients will receive treatment administered according to the country-specific approved prescribing information |
|
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| Topotecan (Japan/Europe) | Drug | Patients will receive treatment administered according to the country-specific approved prescribing information |
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Standard safety monitoring will be performed and adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 |
| Through 30 days following last administration of study medication or until initiation of new anticancer treatment |
| Berlin |
| Germany |
| LungenClinic Grosshansdorf | Großhansdorf | Germany |
| Klinikum Koeln-Merheim | Koplin | Germany |
| St. Hildegardis-Krankenhaus- Katholisches Klinikum Mainz | Mainz | Germany |
| LMU-Campus Innenstadt | München | Germany |
| Azienda Ospedaliero-Universitaria S. Luigi Gonzaga | Orbassano | Turin | Italy |
| IRCCS Centro di Riferimento Oncologico di Aviano, Divisione Oncologia Medica A | Aviano | Italy |
| Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari | Bari | Italy |
| Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico | Catania | Italy |
| Azienda Ospedaliera Instituti Ospitalieri di Cremona | Cremona | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | Italy |
| IEO Istituto Europeo di Oncologia | Milan | Italy |
| Azienda Ospedaliera San Gerardo U.O Oncologia Medica | Monza | Italy |
| Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia | Reggio Emilia | Italy |
| A.O.V.V. Ospedale Eugenio Morelli-Sondalo | Sondalo | Italy |
| National Cancer Center Hospital East | Chiba | 277-8577 | Japan |
| National Kyushi Cancer Center | Fukuoka | 811-1395 | Japan |
| Hyogo Cancer Center | Hyōgo | 673-8588 | Japan |
| Saitama Cancer Center | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| Nippon Medical School Hospital | Tokyo | 113-8603 | Japan |
| Cancer Institute Hospital of Japanese Foundation for Cancer Research | Tokyo | 135-8550 | Japan |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613803 | trifluridine tipiracil drug combination |
| C055866 | amrubicin |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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