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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 : Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: Anetumab ravtansine (BAY94-9343) Drug: Pegylated Liposomal Doxorubicin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
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
Estimated Study Completion Date : November 26, 2019


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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).

  2. Incidence of serious and non-serious adverse events (AEs) [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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)

  8. Incidence of positive anti-drug antibody titer [ Time Frame: Up to 17 months or until discontinuation of study, whichever comes first ]
  9. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02751918     History of Changes
Other Study ID Numbers: 18326
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Mesothelin-expressing platinum-resistant cancer
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Maytansine
Immunoconjugates
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
Immunologic Factors
Physiological Effects of Drugs