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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

NCT02751918

Description:

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 18326
  • NCT ID: NCT02751918

Conditions

  • Ovarian Neoplasms

Interventions

DrugSynonymsArms
Anetumab ravtansine (BAY94-9343)Anetumab ravtansine
Pegylated Liposomal DoxorubicinAnetumab ravtansine

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.

Trial Arms

NameTypeDescriptionInterventions
Anetumab ravtansineExperimentalAnetumab 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.
  • Anetumab ravtansine (BAY94-9343)
  • Pegylated Liposomal Doxorubicin

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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)
Safety Issue:
Description: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).

Secondary Outcome Measures

Measure: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:
Description:
Measure: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:
Description:
Measure: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:
Description:
Measure: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:
Description:
Measure: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:
Description:
Measure: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:
Description:
Measure: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
Safety Issue:
Description:CR (complete response) PR (partial response) SD (stable disease) PD (progressive disease)
Measure:Incidence of positive anti-drug antibody titer
Time Frame:Up to 17 months or until discontinuation of study, whichever comes first
Safety Issue:
Description:
Measure:Incidence of positive neutralizing antibody titer
Time Frame:Up to 17 months or until discontinuation of study, whichever comes first
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bayer

Trial Keywords

  • Mesothelin-expressing platinum-resistant cancer

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