Cancer
Conditions
Keywords
rovalpituzumab tesirine, rollover study, cancer
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.
Interventions
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
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE) | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Disease Progression | 1 | 0 |
| Overall Study | Parent Study Closure | 1 | 0 |
Baseline characteristics
| Characteristic | Arm A: Post-Treatment Follow-Up/Optional Retreatment |
|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 3 |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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.
Population: No participants received treatment or retreatment in this study.