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

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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)

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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