Trial · NCT03086239
A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
NCT03086239, Phase 1, Completed, AbbVie
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer. Trials, record NCT03086239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03086239
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
- NCT number
- NCT03086239
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 29 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Small Cell Lung Cancer
- Interventions
- Rovalpituzumab tesirine
- First posted
- 2017-03-22
- Last updated
- 2021-08-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with dose-limiting toxicities (DLT) | Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1) | DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. |
| Secondary | Duration of response (DOR) | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first. |
| Secondary | Objective Response Rate (ORR) | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | 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. |
| Secondary | Overall survival (OS) | First dose of study drug through long-term follow up; Up to 24 months after participant's first dose. | OS is defined as the time from the date of first dose to the date of death. |
| Secondary | Progression-free survival (PFS) | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first. |
| Secondary | Clinical benefit rate (CBR) | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03086239
GET https://conductscience.org/api/trials/v1/NCT03086239/registered