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This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants with advanced small cell lung cancer (SCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Rovalpituzumab tesirine | Experimental | Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle |
|
| Part B: Rovalpituzumab tesirine | Experimental | Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rovalpituzumab tesirine | Drug | Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLT) | DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. | Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DOR) | DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first. | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Ctr Hosp East /ID# 161432 | Kashiwa-shi | Chiba | 277-8577 | Japan | ||
| Kyushu University Hospital /ID# 161430 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31446987 | Background | Udagawa H, Akamatsu H, Tanaka K, Takeda M, Kanda S, Kirita K, Teraoka S, Nakagawa K, Fujiwara Y, Yasuda I, Okubo S, Shintani M, Kosloski MP, Scripture C, Tamura T, Okamoto I. Phase I safety and pharmacokinetics study of rovalpituzumab tesirine in Japanese patients with advanced, recurrent small cell lung cancer. Lung Cancer. 2019 Sep;135:145-150. doi: 10.1016/j.lungcan.2019.07.025. Epub 2019 Jul 24. | |
| 29290251 |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000620223 | rovalpituzumab tesirine |
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ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. |
| Overall survival (OS) | OS is defined as the time from the date of first dose to the date of death. | First dose of study drug through long-term follow up; Up to 24 months after participant's first dose. |
| Progression-free survival (PFS) | PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first. | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. |
| Clinical benefit rate (CBR) | CBR is defined as the proportion of participants whose overall response is either CR, PR, or Stable Disease (SD) according to RECIST version 1.1. | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. |
| Fukuoka |
| Fukuoka |
| 812-8582 |
| Japan |
| Kinki University -Osakasayama Campus /ID# 161431 | Osakasayama-shi | Osaka | 589-8511 | Japan |
| National Cancer Center Hospital /ID# 161429 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Wakayama Medical University /ID# 161428 | Wakayama | 641-8510 | Japan |
| Derived |
| Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |