Description:
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.
Title
- Brief Title: Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer
- Official Title: An Open-label Phase Ib Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Maximum Tolerated Dose of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin 30 mg/m2 Given Every 3 Weeks in Subjects With Mesothelin-expressing Platinum-resistant Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Clinical Trial IDs
- ORG STUDY ID:
18326
- NCT ID:
NCT02751918
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Anetumab ravtansine (BAY94-9343) | | Anetumab ravtansine |
Pegylated Liposomal Doxorubicin | | Anetumab ravtansine |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Anetumab ravtansine | Experimental | Anetumab ravtansine in combination with pegylated liposomal doxorubicin in subjects with mesothelin-expressing platinum-resistant recurrent ovarian, fallopian tube, or primary peritoneal cancer. Increase/Decrease of Anetumab ravtansine until maximum tolerated dose identified. | - Anetumab ravtansine (BAY94-9343)
- Pegylated Liposomal Doxorubicin
|
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum tolerated dose (MTD) of Anetumab ravtansine in combination with pegylated liposomal doxorubicin when given every three weeks |
Time Frame: | Up to 6 months, minimum: 1 cycle (=21days) |
Safety Issue: | |
Description: | 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). |
Secondary Outcome Measures
Measure: | 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) |
Time Frame: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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) |
Time Frame: | 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 |
Safety Issue: | |
Description: | |
Measure: | Cmax (maximum drug concentration in plasma after first dose administration) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me) |
Time Frame: | 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 |
Safety Issue: | |
Description: | |
Measure: | AUC of total pegylated liposomal doxorubicin |
Time Frame: | At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1 |
Safety Issue: | |
Description: | |
Measure: | AUC(0-tlast) of total pegylated liposomal doxorubicin |
Time Frame: | At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1 |
Safety Issue: | |
Description: | |
Measure: | Cmax of total pegylated liposomal doxorubicin |
Time Frame: | At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose, beginning on day 1 of cycle 1 |
Safety Issue: | |
Description: | |
Measure: | Incidence of patients with CR, PR, SD or PD according to RECIST 1.1 |
Time Frame: | Up to 17 months or until discontinuation of study, whichever comes first |
Safety Issue: | |
Description: | CR (complete response) PR (partial response) SD (stable disease) PD (progressive disease) |
Measure: | Incidence of positive anti-drug antibody titer |
Time Frame: | Up to 17 months or until discontinuation of study, whichever comes first |
Safety Issue: | |
Description: | |
Measure: | Incidence of positive neutralizing antibody titer |
Time Frame: | Up to 17 months or until discontinuation of study, whichever comes first |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Bayer |
Trial Keywords
- Mesothelin-expressing platinum-resistant cancer
Last Updated
November 22, 2019