Trial · NCT02819999
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicities (DLT) of rovalpituzumab tesirine when administered as monotherapy, in series or in combination with frontline chemotherapy to subjects with DLL3 expressing extensive-stage small cell lung cancer (SCLC) | within 21 days after first dose of rovalpituzumab tesirine | For Phase 1a |
| Primary | Treatment emergent adverse events (TEAEs) | through 30 days after last dose of study treatment | For Phase 1a |
| Primary | Incidence of subjects with CTCAE Grade >2 laboratory abnormalities | through 30 days after last dose of study treatment | For Phase 1a |
| Primary | Progression-Free Survival (PFS) | 4 years | For Phase 1b |
| Secondary | Best overall response rate | 4 years | |
| Secondary | Duration of response (DOR) | 4 years | |
| Secondary | Clinical Benefit Rate (CBR) | 4 years | |
| Secondary | Overall Survival (OS) | 4 years | |
| Secondary | Incidence of anti-therapeutic antibodies (ATAs) against rovalpituzumab tesirine | 4 years | |
| Secondary | Progression-free survival (Phase 1a) | 4 years | |
| Secondary | Pharmacokinetic parameters: Cmax (Maximum plasma concentration observed ) | 4 years | |
| Secondary | Pharmacokinetic parameters: AUC0-tau (Area under the plasma concentration-time curve within a dosing interval) | 4 years | |
| Secondary | Pharmacokinetic parameters: AUC0-∞ (Area under the curve from time 0 extrapolated to infinity) | 4 years | |
| Secondary | Pharmacokinetic parameters: Tmax (Time of Cmax) | 4 years | |
| Secondary | Pharmacokinetic parameters: Ctrough (Observed plasma concentrations at trough) | 4 years | |
| Secondary | Pharmacokinetic parameters: T1/2 (Terminal half-life) | 4 years | |
| Secondary | Pharmacokinetic parameters: CL (Clearance) | 4 years | |
| Secondary | Pharmacokinetic parameters: Vss (Volume of distribution at steady state) | 4 years | |
| Secondary | Incidence of TEAEs | 4 years | For Phase 1b |
| Secondary | Changes in vital signs (Heart Rate) | 4 years |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02819999/registered