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Completed

NCT Number: NCT02751918

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

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.

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

UZ Leuven Gasthuisberg, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anetumab ravtansine (BAY94-9343)

Drug

Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle.

Pegylated liposomal doxorubicin

Drug

Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2016
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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