Ovarian NeoplasmsPhase 1NCT02751918
Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer
A Phase 1 study testing Anetumab ravtansine (BAY94-9343) and Pegylated Liposomal Doxorubicin in people with Ovarian Neoplasms, run by Bayer at 9 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Anetumab ravtansine (BAY94-9343) and Pegylated Liposomal Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 8 Jun 2016to 31 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Spain4 sites
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, 08035
Clinica Universidad de Navarra CUN en Madrid
Madrid, 28027
Clínica Universidad de Navarra CUN
Pamplona, 31008
Instituto Valenciano de Oncología
Valencia, 46009
United States3 sites
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
Yale University School of Medicine
New Haven, Connecticut, 06520-8064
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, 73104
About this study
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
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.
- Conditions
- Ovarian Neoplasms
- Being tested
- Anetumab ravtansine (BAY94-9343), Pegylated Liposomal Doxorubicin
- Keywords
- Mesothelin-expressing platinum-resistant cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anetumab ravtansine (BAY94-9343)Drug
Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle.
Pegylated Liposomal DoxorubicinDrug
Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Anetumab ravtansine (BAY94-9343); Drug: Pegylated Liposomal Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 6 months, minimum: 1 cycle (=21days)
Incidence of serious and non-serious adverse events (AEs)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
CR (complete response) PR (partial response) SD (stable disease) PD (progressive disease)
Measured: Up to 17 months or until discontinuation of study, whichever comes first
Incidence of positive anti-drug antibody titer
Measured: Up to 17 months or until discontinuation of study, whichever comes first
Incidence of positive neutralizing antibody titer
Measured: Up to 17 months or until discontinuation of study, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start8 Jun 2016
- Primary completion23 Aug 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751918
- Sponsor's protocol ID
- 18326
- Status last verified
- Nov 2019
- First submitted
- 22 Apr 2016
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36564099
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02751918
- Acronym / sponsor ID
- 18326
- Conditions
- Ovarian Neoplasms
- Keywords
- Mesothelin-expressing platinum-resistant cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anetumab ravtansine | Experimental | Drug: Anetumab ravtansine (BAY94-9343), Drug: Pegylated Liposomal DoxorubicinAnetumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anetumab ravtansine (BAY94-9343)Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle. | Drug | Anetumab ravtansine |
| Pegylated Liposomal DoxorubicinPegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle. | Drug | Anetumab ravtansine |
Primary outcome
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
9 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Derived from this study: PubMed 36564099Santin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anetumab ravtansine (BAY94-9343) and Pegylated Liposomal Doxorubicin in people with Ovarian Neoplasms, run by Bayer at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, United States, Belgium, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.