Solid Tumors
Conditions
Keywords
Solid tumors, Mesothelin, Mesothelioma
Brief summary
The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.
Detailed description
The primary objective of the study is to collect long-term safety information on anetumab ravtansine and to enable patients, who received an anetumab ravtansine-containing treatment in any Bayer-sponsored anetumab ravtansine parent study, to continue the treatment. The secondary objective is to further investigate the efficacy of the drug.
Interventions
DRUGBAY94-9343 (Anetumab ravtansine)
BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants ongoing in an applicable Bayer-sponsored anetumab ravtansine parent study at the time of its planned study closure. * For on-treatment participants: participant is eligible to receive the next dose of study intervention per the parent study protocol. * For on-treatment participants: any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption. For applicable studies: should treatment be permanently interrupted in the parent study, participants may be enrolled in the follow-up portion of the rollover study.
Exclusion criteria
* For on-treatment participants: a positive serum pregnancy test. * For on-treatment participants: use of one or more of the prohibited medications listed in the respective parent study protocol. * Participants who are receiving standard-of-care agent(s) but not anetumab ravtansine in the parent study, and are able to receive standard-of-care agent outside of the clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs | Approximately 3 years (from first study treatment until safety follow-up) | Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Approximately 3 years (from first study treatment until safety follow-up) | Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. Number (%) of participants with event: 5 (55.6%) and Number (%) of participants censored: 4 (44.4%). |
Countries
France, Italy, Poland, United States
Participant flow
Recruitment details
The study was conducted at 7 study centers in 4 countries worldwide between 03-Jun-2019 (first participant first visit) and 18-May-2022 (last participant last visit). Entering participants had to have been treated with anetumab ravtansine in an applicable Bayer sponsored anetumab ravtansine parent study.
Pre-assignment details
A total of 10 participants were screened in this study; of whom 9 participants started study treatment and 1 participant was a screening failure.
Participants by arm
| Arm | Count |
|---|---|
| Anetumab Ravtansine Adult participants with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study.
8 participants received anetumab ravtansine monotherapy and 1 participant received anetumab ravtansine in combination with gemcitabine. Pooled results were reported. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Progressive disease | 3 |
| Overall Study | Subject decision: Covid-19 Pandemic related | 1 |
Baseline characteristics
| Characteristic | Anetumab Ravtansine |
|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 16.2 |
| Ethnicity Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 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 | 1 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 9 |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 2 / 9 |
Outcome results
Primary
Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events.
Time frame: Approximately 3 years (from first study treatment until safety follow-up)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anetumab Ravtansine | Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs | Any TEAE | 9 Participants |
| Anetumab Ravtansine | Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs | Serious TEAE | 2 Participants |
| Anetumab Ravtansine | Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs | Any study drug-related TEAE | 8 Participants |
| Anetumab Ravtansine | Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs | Any study drug-related Serious TEAE | 0 Participants |
Secondary
Overall Survival
Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. Number (%) of participants with event: 5 (55.6%) and Number (%) of participants censored: 4 (44.4%).
Time frame: Approximately 3 years (from first study treatment until safety follow-up)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anetumab Ravtansine | Overall Survival | 25th percentile | 17.6 Months |
| Anetumab Ravtansine | Overall Survival | Median | 34.1 Months |
| Anetumab Ravtansine | Overall Survival | 75th percentile | NA Months |