Ovarian Neoplasms
Conditions
Keywords
Mesothelin-expressing platinum-resistant cancer
Brief summary
Anetumab ravtansine is developed for the treatment of patients with recurrent platinum-resistant ovarian cancer. The purpose of the proposed trial is to identify the maximum tolerated dose of anetumab ravtansine that could be safely combined with pegylated liposomal doxorubicin in this indication.
Interventions
Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle.
DRUGPegylated Liposomal Doxorubicin
Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with locally invasive or metastatic, epithelial ovarian, fallopian tube, or primary peritoneal cancer * Subjects must provide samples of tumor tissue * Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
* Subjects with low-grade ovarian, fallopian tube, or Primary peritoneal cancer * Women who are pregnant or breast feeding * Subjects who have an active hepatitis B virus or hepatitis C virus infection requiring treatment as defined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) of Anetumab ravtansine in combination with pegylated liposomal doxorubicin when given every three weeks | Up to 6 months, minimum: 1 cycle (=21days) | MTD is defined as the highest dose of anetumab ravtansine administered in combination with pegylated liposomal doxorubicin that can be given such that not more than 1 of 6 subjects at a given dose level experiences a dose-limiting toxicity (DLT). |
| Incidence of serious and non-serious adverse events (AEs) | Up to 6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (maximum drug concentration in plasma after first dose administration) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me) | At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 24h, 48h, 168h, 336h and 504h post-dose, beginning on day 1 of cycle 1 | — |
| AUC of total pegylated liposomal doxorubicin | At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1 | — |
| AUC(0-tlast) of total pegylated liposomal doxorubicin | At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1 | — |
| AUC (area under the plasma concentration vs. time curve from zero to infinity after single (first) dose) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me) | At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 24h, 48h, 168h, 336h and 504h post-dose, beginning on day 1 of cycle 1 | — |
| Incidence of patients with CR, PR, SD or PD according to RECIST 1.1 | Up to 17 months or until discontinuation of study, whichever comes first | CR (complete response) PR (partial response) SD (stable disease) PD (progressive disease) |
| Incidence of positive anti-drug antibody titer | Up to 17 months or until discontinuation of study, whichever comes first | — |
| Incidence of positive neutralizing antibody titer | Up to 17 months or until discontinuation of study, whichever comes first | — |
| Cmax of total pegylated liposomal doxorubicin | At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose, beginning on day 1 of cycle 1 | — |
| AUC(0-tlast) (AUC from time zero to the last data point > lower limit of quantification) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me) | At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 24h, 48h, 168h, 336h and 504h post-dose, beginning on day 1 of cycle 1 | — |
Countries
Belgium, Moldova, Spain, United States
Outcome results
None listed