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

Bayer

Status and phase: Completed; Phase 1

Conditions: Ovarian Neoplasms

Treatments: Drug: Anetumab ravtansine (BAY94-9343); Drug: Pegylated Liposomal Doxorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02751918

18326

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Anetumab ravtansine

Experimental group

Description:

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.

Treatment:

Drug: Anetumab ravtansine (BAY94-9343)

Drug: Pegylated Liposomal Doxorubicin