Trial · NCT01901653
Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer
NCT01901653, Phase 1, Phase 2, Completed, Stemcentrx; results first posted 2018-07-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer. Trials, record NCT01901653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01901653
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer
- NCT number
- NCT01901653
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 82 participants, actual
- Lead sponsor
- Stemcentrx
- Conditions
- Recurrent Small Cell Lung Cancer
- Interventions
- Rovalpituzumab tesirine (SC16LD6.5)
- First posted
- 2013-07-17
- Last updated
- 2018-08-09
- Results first posted
- 2018-07-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine | The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length. | MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT). |
| Secondary | Objective Response Rate (ORR) | From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months). | Overall response was assessed at each visit post-baseline based on a subject's lesion measurements or assessments (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\], or not evaluable as defined by RECIST v1.1, plus an additional category of early death). The best overall response was then determined. A subject was defined as having an objective response if they had a best overall response of CR or PR prior to receiving any subsequent anticancer therapy; confirmed response is confirmation of CR or PR at least 4 weeks from the initial determination per RECIST v1.1. Subjects with a post-baseline assessment were included in the calculations for objective response rate (ORR). Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). |
| Secondary | Duration of Response (DOR) | From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months). | Duration of response (DOR) was defined as the number of months from the initial CR or PR to the time of disease progression or death, whichever occurred first. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). |
| Secondary | Clinical Benefit Rate (CBR) | From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months). | Clinical Benefit is defined as a subject with best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) prior to receiving any subsequent anticancer therapy; as defined by RECIST version 1.1. CBR is defined as the proportion of subjects with Clinical Benefit based on assessment of overall response. CBR will be presented as a number and percentage with 95% confidence bounds. Any subjects not exhibiting a response (CR or PR or SD) are considered non-responders. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). |
| Secondary | Progression-free Survival (PFS) | From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months). | Progression-free survival (PFS) was defined as the number of months from the first day of study drug administration to disease recurrence or progression, or death on study. Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC). |
| Secondary | Overall Survival | From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months). | Overall survival (OS) was defined as the time from the first day of study treatment to death. Subjects who were alive were censored at the date of last known alive. |
| Secondary | Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC) | From Day 1 of first dose to End of Dose Cycle | The maximum serum concentration (Cmax; measured in μg/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing cycle. |
| Secondary | Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC | From Day 1 of first dose to End of Dose Cycle | The area under the serum concentration-time curve (AUC; measured in μg•d/mL) is a method of measurement to determine the total exposure of a drug in blood serum. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine | The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length. | All subjects from Phase 1a Dose Escalation: Cohort 1 to 8 who received at least 1 dose of study drug. | mg/kg | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months). | Subjects with at least one post-dose assessment. All LCNEC subjects were analyzed. No LCNEC subjects achieved CR or PR and, therefore, the ORR was 0%. | percentage of subjects | NUMBER |
| SECONDARY | Duration of Response (DOR) | From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months). | Subjects with at least one post-dose assessment. No LCNEC subjects achieved CR or PR, therefore DOR was not analyzed. | months | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) | From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months). | Subjects with at least one post-dose assessment. | percentage of subjects | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months). | Subjects with at least one post-dose assessment. | months | MEDIAN |
| SECONDARY | Overall Survival | From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months). | Subjects with at least one post-dose assessment. | months | MEDIAN |
| SECONDARY | Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC) | From Day 1 of first dose to End of Dose Cycle | All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC | From Day 1 of first dose to End of Dose Cycle | All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated. | μg•d/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine | Rovalpituzumab Tesirine | 0.4 | mg/kg | ||
| Objective Response Rate (ORR) | SCLC Subjects | ORR unconfirmed by Investigator | 25 | 95% Confidence Interval 14.98 to 38.44 | percentage of subjects |
| Objective Response Rate (ORR) | LCNEC Subjects | ORR unconfirmed by Investigator | 0 | 95% Confidence Interval 0 to 36.94 | percentage of subjects |
| Objective Response Rate (ORR) | SCLC Subjects | ORR confirmed by Investigator | 17 | 95% Confidence Interval 8.44 to 28.97 | percentage of subjects |
| Objective Response Rate (ORR) | LCNEC Subjects | ORR confirmed by Investigator | 0 | 95% Confidence Interval 0 to 36.94 | percentage of subjects |
| Objective Response Rate (ORR) | SCLC Subjects | ORR unconfirmed by IRC | 27 | 95% Confidence Interval 16.14 to 40.96 | percentage of subjects |
| Objective Response Rate (ORR) | LCNEC Subjects | ORR unconfirmed by IRC | 0 | 95% Confidence Interval 0 to 39.94 | percentage of subjects |
| Objective Response Rate (ORR) | SCLC Subjects | ORR confirmed by IRC | 16 | 95% Confidence Interval 7.77 to 28.8 | percentage of subjects |
| Objective Response Rate (ORR) | LCNEC Subjects | ORR confirmed by IRC | 0 | 95% Confidence Interval 0 to 36.94 | percentage of subjects |
| Duration of Response (DOR) | SCLC Subjects | DOR by INV | 2.89 | 95% Confidence Interval 2.17 to 6.51 | months |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1a: Cohort 1 Small Cell Lung Cancer (SCLC) | 3 | |
| Overall Study | STARTED | Phase 1a: Cohort 2 (SCLC) | 1 | |
| Overall Study | STARTED | Phase 1a: Cohort 3 (SCLC) | 11 | |
| Overall Study | STARTED | Phase 1a: Cohort 4 (SCLC) | 3 | |
| Overall Study | STARTED | Phase 1a: Cohort 5 (SCLC) | 2 | |
| Overall Study | STARTED | Phase 1a: Cohort 6 (SCLC) | 3 | |
| Overall Study | STARTED | Phase 1a: Cohort 7 (SCLC) | 7 | |
| Overall Study | STARTED | Phase 1a: Cohort 8 (SCLC) | 10 | |
| Overall Study | STARTED | Phase 1a: Cohort 8 Large Cell Neuroendocrine Carcinoma (LCNEC) | 1 | |
| Overall Study | STARTED | Phase 1b: Retreatment (SCLC) | 18 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events1,378
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cohort 1 (SCLC) | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cohort 2 (SCLC) | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cohort 3 (SCLC) | 1 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cohort 4 (SCLC) | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cohort 5 (SCLC) | 1 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cohort 6 (SCLC) | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cohort 7 (SCLC) | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cohort 8 (SCLC) | 4 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cohort 8 (LCNEC) | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: Retreatment (SCLC) | 5 | 18 |
1 to 10 of 1,378Source ClinicalTrials.gov
See all 1,378 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1a: Cohort 1 (SCLC) | ||
| Total, all-cause mortality | Phase 1a: Cohort 2 (SCLC) | ||
| Total, all-cause mortality | Phase 1a: Cohort 3 (SCLC) | ||
| Total, all-cause mortality | Phase 1a: Cohort 4 (SCLC) | ||
| Total, all-cause mortality | Phase 1a: Cohort 5 (SCLC) | ||
| Total, all-cause mortality | Phase 1a: Cohort 6 (SCLC) | ||
| Total, all-cause mortality | Phase 1a: Cohort 7 (SCLC) | ||
| Total, all-cause mortality | Phase 1a: Cohort 8 (SCLC) | ||
| Total, all-cause mortality | Phase 1a: Cohort 8 (LCNEC) | ||
| Total, all-cause mortality | Phase 1b: Retreatment (SCLC) |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27932068 | DERIVED |
Source PubMed
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/NCT01901653
GET https://conductscience.org/api/trials/v1/NCT01901653/results?page=2