Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anetumab ravtansine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anetumab ravtansine (BAY94-9343) | Drug | Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 6 months, minimum: 1 cycle (=21days) |
| Incidence of serious and non-serious adverse events (AEs) | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36564099 | Derived | Santin AD, Vergote I, Gonzalez-Martin A, Moore K, Oaknin A, Romero I, Diab S, Copeland LJ, Monk BJ, Coleman RL, Herzog TJ, Siegel J, Kasten L, Schlicker A, Schulz A, Kochert K, Walter AO, Childs BH, Elbi C, Bulat I. Safety and activity of anti-mesothelin antibody-drug conjugate anetumab ravtansine in combination with pegylated-liposomal doxorubicin in platinum-resistant ovarian cancer: multicenter, phase Ib dose escalation and expansion study. Int J Gynecol Cancer. 2023 Apr 3;33(4):562-570. doi: 10.1136/ijgc-2022-003927. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pegylated Liposomal Doxorubicin | Drug | Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle. |
|
| 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) | 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 | 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 | 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 | 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) | Up to 17 months or until discontinuation of study, whichever comes first |
| Incidence of positive anti-drug antibody titer | Up to 17 months or until discontinuation of study, whichever comes first |
| Incidence of positive neutralizing antibody titer | Up to 17 months or until discontinuation of study, whichever comes first |
| New Haven |
| Connecticut |
| 06520-8064 |
| United States |
| Oklahoma University Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| The Institute of Oncology | Chisinau | 2025 | Moldova |
| Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona | 08035 | Spain |
| Clinica Universidad de Navarra CUN en Madrid | Madrid | 28027 | Spain |
| Clínica Universidad de Navarra CUN | Pamplona | 31008 | Spain |
| Instituto Valenciano de Oncología | Valencia | 46009 | Spain |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000595240 | anetumab ravtansine |
| C506643 | liposomal doxorubicin |
Not provided
Not provided
Not provided