A Phase 2 interventional study of rovalpituzumab tesirine and rovalpituzumab tesirine in Cancer, sponsored by AbbVie. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including:
Exclusion Criteria:
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.
Drug: rovalpituzumab tesirine
Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.
Drug: rovalpituzumab tesirine
Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles
Also known as: SC16LD6.5
Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.
Also known as: SC16LD6.5
Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE)
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.
Time frame: From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years.
This rollover follow-up extension study was conducted in 3 sites in the United States. Participants enrolled while in post-treatment follow-up in parent studies SCRX001-002 (NCT02674568) and SCRX001-007 (NCT02874664).
| Milestone | Arm A: Post-Treatment Follow-Up/Optional Retreatment | Arm B: Continued Treatment |
|---|---|---|
| Started | 3 | 0 |
| Received treatment or retreatment | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 3 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Disease progression | 1 | 0 |
| Withdrew: Parent study closure | 1 | 0 |
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.
No measurements were reported for this outcome.
Collected over up to 13.6 months (maximum time on study). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Post-Treatment Follow-Up/Optional Retreatment | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) |
| Event | Arm A: Post-Treatment Follow-Up/Optional Retreatment |
|---|---|
| InsomniaPsychiatric disorders | 1/3 |
| NauseaGastrointestinal disorders | 1/3 |
| ConstipationGastrointestinal disorders | 1/3 |
All enrolled participants
| Age, Continuous(years) | Arm A: Post-Treatment Follow-Up/Optional Retreatment |
|---|---|
| Mean | 63.7 ± 6.7 |
| Sex: Female, Male(Participants) | Arm A: Post-Treatment Follow-Up/Optional Retreatment |
|---|---|
| Female | 2 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Post-Treatment Follow-Up/Optional Retreatment |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Arm A: Post-Treatment Follow-Up/Optional Retreatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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