NCT02751918

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Typical duration for phase_1

Geographic Reach
4 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

3.2 years

First QC Date

April 22, 2016

Last Update Submit

November 21, 2019

Conditions

Ovarian Neoplasms

Keywords

Mesothelin-expressing platinum-resistant cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (9)

  • 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)

    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

  • +4 more secondary outcomes

Study Arms (1)

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.

Drug: Anetumab ravtansine (BAY94-9343)Drug: Pegylated Liposomal Doxorubicin

Interventions

Anetumab ravtansine (BAY94-9343)DRUG

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

Anetumab ravtansine
Pegylated Liposomal DoxorubicinDRUG

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

Anetumab ravtansine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rocky Mountain Cancer Centers

Aurora, Colorado, 80012, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520-8064, United States

Location

Oklahoma University Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

The Institute of Oncology

Chisinau, 2025, Moldova

Location

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, 08035, Spain

Location

Clinica Universidad de Navarra CUN en Madrid

Madrid, 28027, Spain

Location

Clínica Universidad de Navarra CUN

Pamplona, 31008, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Related Publications (1)

  • 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.

    PMID: 36564099DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

anetumab ravtansineliposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2016

First Posted

April 26, 2016

Study Start

June 8, 2016

Primary Completion

August 23, 2019

Study Completion

October 31, 2019

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

ES(4)MO(1)US(3)BE(1)