A Phase 1 interventional study of Anetumab ravtansine (BAY94-9343) and Pegylated Liposomal Doxorubicin in Ovarian Neoplasms, sponsored by Bayer. Completed at 9 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-22.
Sponsored by Bayer · Phase 1, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 65 is close to the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
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Exclusion Criteria:
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.
Drug: Anetumab ravtansine (BAY94-9343) · Drug: Pegylated Liposomal Doxorubicin
Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle.
Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle.
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)
Incidence of serious and non-serious adverse events (AEs)
Time frame: Up to 6 months
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
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
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
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
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
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
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
Incidence of positive anti-drug antibody titer
Time frame: Up to 17 months or until discontinuation of study, whichever comes first
Incidence of positive neutralizing antibody titer
Time frame: Up to 17 months or until discontinuation of study, whichever comes first
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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