Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02751918
• Date of registration: 22/04/2016
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer
• Scientific 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
• Date of first enrolment: June 8, 2016
• Target sample size: 65
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02751918
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium, France, Japan, Moldova, Republic of, Spain, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Neoplasms

Intervention(s)

Drug: Anetumab ravtansine (BAY94-9343)

Drug: Pegylated Liposomal Doxorubicin

Primary Outcome(s)

Incidence of serious and non-serious adverse events (AEs) [Time Frame: Up to 6 months]

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)]

Secondary Outcome(s)

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]

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]

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]

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]

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]

Incidence of positive neutralizing antibody titer [Time Frame: Up to 17 months or until discontinuation of study, whichever comes first]

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]

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]

Incidence of positive anti-drug antibody titer [Time Frame: Up to 17 months or until discontinuation of study, whichever comes first]

Secondary ID(s)

18326

Source(s) of Monetary Support

Please refer to primary and secondary sponsors