Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer
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ClinicalTrials.gov Identifier: NCT02751918 |
Recruitment Status :
Completed
First Posted : April 26, 2016
Last Update Posted : November 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Neoplasms | Drug: Anetumab ravtansine (BAY94-9343) Drug: Pegylated Liposomal Doxorubicin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | June 8, 2016 |
Actual Primary Completion Date : | August 23, 2019 |
Actual Study Completion Date : | October 31, 2019 |
Arm | Intervention/treatment |
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Experimental: Anetumab ravtansine
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.
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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. |
- Maximum tolerated dose (MTD) of Anetumab ravtansine in combination with pegylated liposomal doxorubicin when given every three weeks [ Time Frame: Up to 6 months, minimum: 1 cycle (=21days) ]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).
- 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 [ Time Frame: Up to 17 months or until discontinuation of study, whichever comes first ]CR (complete response) PR (partial response) SD (stable disease) PD (progressive disease)
- 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 ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751918
United States, Colorado | |
Rocky Mountain Cancer Centers | |
Aurora, Colorado, United States, 80012 | |
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520-8064 | |
United States, Oklahoma | |
Oklahoma University Health Science Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
Belgium | |
UZ Leuven Gasthuisberg | |
Leuven, Belgium, 3000 | |
Moldova, Republic of | |
The Institute of Oncology | |
Chisinau, Moldova, Republic of, 2025 | |
Spain | |
Ciutat Sanitària i Universitaria de la Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Clinica Universidad de Navarra CUN en Madrid | |
Madrid, Spain, 28027 | |
Clínica Universidad de Navarra CUN | |
Pamplona, Spain, 31008 | |
Instituto Valenciano de Oncología | |
Valencia, Spain, 46009 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT02751918 |
Other Study ID Numbers: |
18326 |
First Posted: | April 26, 2016 Key Record Dates |
Last Update Posted: | November 22, 2019 |
Last Verified: | November 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Mesothelin-expressing platinum-resistant cancer |
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders |
Doxorubicin Liposomal doxorubicin Maytansine Anetumab ravtansine Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Immunoconjugates |