Trial Outcomes & Findings for A Long-Term Study of Rovalpituzumab Tesirine (NCT NCT03543358)
NCT ID: NCT03543358
Last Updated: 2021-01-05
Results Overview
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.
COMPLETED
PHASE2
3 participants
From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years.
2021-01-05
Participant Flow
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).
Participant milestones
| Measure |
Arm A: Post-Treatment Follow-Up/Optional Retreatment
Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive 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 (retreatment may be repeated).
|
Arm B: Continued Treatment
Participants who entered the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study. Participants receive rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
Received Treatment or Retreatment
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Post-Treatment Follow-Up/Optional Retreatment
Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive 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 (retreatment may be repeated).
|
Arm B: Continued Treatment
Participants who entered the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study. Participants receive rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Disease Progression
|
1
|
0
|
|
Overall Study
Parent Study Closure
|
1
|
0
|
Baseline Characteristics
A Long-Term Study of Rovalpituzumab Tesirine
Baseline characteristics by cohort
| Measure |
Arm A: Post-Treatment Follow-Up/Optional Retreatment
n=3 Participants
Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive 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 (retreatment may be repeated).
|
|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 6.7 • n=39 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years.Population: No participants received treatment or retreatment in this study.
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.
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Post-Treatment Follow-Up/Optional Retreatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Post-Treatment Follow-Up/Optional Retreatment
n=3 participants at risk
Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive 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 (retreatment may be repeated).
|
|---|---|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • up to 13.6 months (maximum time on study)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • up to 13.6 months (maximum time on study)
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • up to 13.6 months (maximum time on study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER