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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-08

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anetumab ravtansine

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.

Group Type EXPERIMENTAL

Anetumab ravtansine (BAY94-9343)

Intervention Type DRUG

Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle.

Pegylated Liposomal Doxorubicin

Intervention Type DRUG

Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle.

Interventions

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Anetumab ravtansine (BAY94-9343)

Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle.

Intervention Type DRUG

Pegylated Liposomal Doxorubicin

Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No