A Multicenter, Long-Term, Rollover Extension Study of Rovalpituzumab Tesirine
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 3
- Locations
- 3
- Primary Endpoint
- Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Arm A: Post-Treatment Follow-Up/Optional Retreatment
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.
Intervention: rovalpituzumab tesirine (Drug)
Arm B: Continued Treatment
Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.
Intervention: rovalpituzumab tesirine (Drug)
Outcomes
Primary Outcomes
Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE)
Time Frame: From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs and serious TEAEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on AEs, please see the Adverse Event section.
Secondary Outcomes
No secondary outcomes reported