Trial Condition(s):
Ovarian Neoplasms
Phase Ib study of anetumab ravtansine in combination with pegylated liposomal doxorubicin in patients with recurrent mesothelin-expressing platinum-resistant cancer
Bayer Identifier:
18326
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Oklahoma University Health Science Center Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yale University School of Medicine New Haven, United States, 06520-8064 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Institute of Oncology Chisinau, Moldova, 2025 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinica Universidad de Navarra CUN en Madrid Madrid, Spain, 28027 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Instituto Valenciano de Oncología Valencia, Spain, 46009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Rocky Mountain Cancer Centers Aurora, United States, 80012 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clínica Universidad de Navarra CUN Pamplona, Spain, 31008 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Maximum tolerated dose (MTD) of Anetumab ravtansine in combination with pegylated liposomal doxorubicin when given every three weeksMTD is defined as the highest dose of anetumab ravtansine administered in combination with pegylated liposomal doxorubicin that can be given such that not more than 1 of 6 subjects at a given dose level experiences a dose-limiting toxicity (DLT).Timeframe: Up to 6 months, minimum: 1 cycle (=21days)
- Incidence of serious and non-serious adverse events (AEs)Timeframe: Up to 6 months
Secondary Outcome
- 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)Timeframe: 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) (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)Timeframe: 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
- Cmax (maximum drug concentration in plasma after first dose administration) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me)Timeframe: 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 of total pegylated liposomal doxorubicinTimeframe: At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1
- AUC(0-tlast) of total pegylated liposomal doxorubicinTimeframe: At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1
- Cmax of total pegylated liposomal doxorubicinTimeframe: At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose, beginning on day 1 of cycle 1
- Incidence of patients with CR, PR, SD or PD according to RECIST 1.1CR (complete response) PR (partial response) SD (stable disease) PD (progressive disease)Timeframe: Up to 17 months or until discontinuation of study, whichever comes first
- Incidence of positive anti-drug antibody titerTimeframe: Up to 17 months or until discontinuation of study, whichever comes first
- Incidence of positive neutralizing antibody titerTimeframe: Up to 17 months or until discontinuation of study, whichever comes first
Additional Information
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