Clinical trial · Interventional
A Long-Term Study of Rovalpituzumab Tesirine
A Multicenter, Long-Term, Rollover Extension Study of Rovalpituzumab Tesirine
NCT03543358CI-TRIAL-00049266completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rovalpituzumab tesirine | Drug | Rovalpituzumab Tesirine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Post-Treatment Follow-Up/Optional Retreatment
- description
- Arm A includes participants who enter the extension study while in post-treatment follow-up. This arm includes optional rovalpituzumab tesirine retreatment plus dexamethasone per participant per retreatment period.
- interventionNames
- Drug: rovalpituzumab tesirine
- type
- EXPERIMENTAL
- label
- Arm B: Continued Treatment
- description
- Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.
- interventionNames
- Drug: rovalpituzumab tesirine
Primary outcomes (1)
- measure
- Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study. * Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window. For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including: * Tolerated their initial 2 doses of rovalpituzumab tesirine. * Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment. * Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine. * Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic, kidney, and liver function, per protocol. * In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol. Exclusion Criteria: * Subjects not previously enrolled in a rovalpituzumab tesirine study.
References
Publications (0)
Data not yet available
No reference posted for this study.