Study Completed

Ovarian Neoplasms

Bayer Identifier:

18326

ClinicalTrials.gov Identifier:

NCT02751918

EudraCT Number:

Not Available

EU CT Number:

Not Available

Phase Ib study of anetumab ravtansine in combination with pegylated liposomal doxorubicin in patients with recurrent mesothelin-expressing platinum-resistant cancer

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.

Key Participants Requirements

Sex

Female

Age

18 - N/A

Trial summary

Enrollment Goal

Trial Dates

June 2016 - October 2019

Phase

Phase 1

Could I Receive a placebo

Products

Anetumab ravtansine (BAY94-9343)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Oklahoma University Health Science Center	Oklahoma City, 73104, United States
Completed	Yale University School of Medicine	New Haven, 06520-8064, United States
Completed	The Institute of Oncology	Chisinau, 2025, Moldova
Completed	UZ Leuven Gasthuisberg	LEUVEN, 3000, Belgium
Completed	Clinica Universidad de Navarra CUN en Madrid	Madrid, 28027, Spain
Completed	Ciutat Sanitària i Universitaria de la Vall d'Hebron	Barcelona, 08035, Spain
Completed	Instituto Valenciano de Oncología	Valencia, 46009, Spain
Withdrawn	Institut Gustave Roussy	VILLEJUIF CEDEX, 94805, France
Withdrawn	University of Cincinnati	Cincinnati, 45267, United States
Withdrawn	University of California, Los Angeles	Los Angeles, 90095, United States
Completed	Rocky Mountain Cancer Centers	Aurora, 80012, United States
Withdrawn	Oncology Associates of Oregon	Eugene, 97401, United States
Completed	Clínica Universidad de Navarra CUN	Pamplona, 31008, Spain
Withdrawn	National Cancer Center Hospital	Chuo-ku, 104-0045, Japan
Withdrawn	Saitama Medical University International Medical Center	Hidaka, 350-1298, Japan
Withdrawn	Nippon Medical School Musashikosugi Hospital	Kawasaki, 211-8533, Japan
Withdrawn	Aichi Cancer Center Hospital	Nagoya, 464-8681, Japan

Primary Outcome

Maximum tolerated dose (MTD) of Anetumab ravtansine in combination with pegylated liposomal doxorubicin when given every three weeks
MTD 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).
Time Frame:
Up to 6 months, minimum: 1 cycle (=21days)
Safety Issue:
Yes
Incidence of serious and non-serious adverse events (AEs)
Time Frame:
Up to 6 months
Safety Issue:
Yes

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)
Time Frame:
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
Safety Issue:
No
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)
Time Frame:
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
Safety Issue:
No
Cmax (maximum drug concentration in plasma after first dose administration) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me)
Time Frame:
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
Safety Issue:
No
AUC of total pegylated liposomal doxorubicin
Time Frame:
At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1
Safety Issue:
No
AUC(0-tlast) of total pegylated liposomal doxorubicin
Time Frame:
At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1
Safety Issue:
No
Cmax of total pegylated liposomal doxorubicin
Time Frame:
At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose, beginning on day 1 of cycle 1
Safety Issue:
No
Incidence of patients with CR, PR, SD or PD according to RECIST 1.1
CR (complete response) PR (partial response) SD (stable disease) PD (progressive disease)
Time Frame:
Up to 17 months or until discontinuation of study, whichever comes first
Safety Issue:
No
Incidence of positive anti-drug antibody titer
Time Frame:
Up to 17 months or until discontinuation of study, whichever comes first
Safety Issue:
No
Incidence of positive neutralizing antibody titer
Time Frame:
Up to 17 months or until discontinuation of study, whichever comes first
Safety Issue:
No

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.