Trials / Completed
CompletedNCT02751918
Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anetumab ravtansine (BAY94-9343) | Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle. |
| DRUG | Pegylated Liposomal Doxorubicin | Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle. |
Timeline
- Start date
- 2016-06-08
- Primary completion
- 2019-08-23
- Completion
- 2019-10-31
- First posted
- 2016-04-26
- Last updated
- 2019-11-22
Locations
9 sites across 4 countries: United States, Belgium, Moldova, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02751918. Inclusion in this directory is not an endorsement.