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Ovarian Epithelial Cancer RecurrentPhase 2NCT01899599

PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer

A Phase 2 study testing PankoMab-GEX in people with Ovarian Epithelial Cancer Recurrent and Fallopian Tube Cancer, run by Glycotope GmbH at 50 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian, fallopian tube or primary peritoneal cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
PankoMab-GEX
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
50 sitesin 8 countries
Study dates
Sep 2013to 28 Jul 2017
Phase
Phase 2
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

  • Female patients ≥18 years of age
  • Histologically-confirmed, TA-MUC1-positive, recurrent epithelial ovarian, or fallopian-tube cancer or primary peritoneal cancer with high-grade (Grade 2 or 3) serous features or a serous component
  • Availability of tumor tissue samples (slices or block) for immune-histological confirmation of TA-MUC1 status (tissue samples could also be stored for other further specified biomarker assessments)
  • Patients were to have received at least 2 lines but not more than 5 lines of chemotherapy prior to start of maintenance treatment; neo-adjuvant lines did not count as previous lines of treatment
  • Patients had to have a documented response to or SD following the most recent line of chemotherapy (any regimen and duration in accordance with local or international guidelines or within IEC-approved studies) and received the last dose of said chemotherapy ≤6 weeks prior to randomization (response to prior chemotherapy was defined as a PR/CR according to radiological response criteria and/or a confirmed decline in tumor marker CA125 ≥50% from the pre-treatment value for patients who had a pre-treatment value ≥2 x the upper limit of normal [ULN]; SD was defined as stable disease according to radiological response criteria with a confirmed lack of increase in tumor marker CA125 from the pre-treatment value for patients who had a pre-treatment value ≥2 × ULN and no clinical progression). Prior to randomization, CA125 had to be below the ULN, or CA125 levels were not to increase >15% within a time frame >7 days if above the ULN
  • Progression-free interval of ≤12 months immediately preceding the chemotherapy to which the patient had just responded
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  • Sensitive or resistant to the most recent platinum-based chemotherapy preceding the chemotherapy to which the patient had just responded (sensitivity was thereby defined as a recurrence of disease >6 to ≤12 months after the end of platinum-based chemotherapy, and resistantance was defined as a recurrence of disease ≤6 months after the end of the platinum-based chemotherapy)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Recovered from all chemotherapy-related toxicities to Grade 1 or Grade 0 according to the NCI-CTCAE Version 4.0, with the exception of alopecia (any grade) and peripheral neuropathy (≤Grade 2)
  • Adequate bone marrow and hepatic function at Screening:
  • Hemoglobin ≥9 g/dL
  • White blood cell count ≥3.0 × 109/L
  • Absolute neutrophil count ≥1.5 × 109/L- Platelet count ≥100 × 109/L
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 × ULN (<5 × ULN in case of liver metastases)
  • Bilirubin <1.5 × ULN (<3 × ULN in case of liver metastases)
  • Creatinine <1.5 × ULN
  • Any patient with childbearing potential (i.e. not surgically sterile or post-menopausal for >1 year) had to use highly effective contraceptives with a Pearl index <1% according to the "Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals" (CPMP/ICH/286/95) of the European Medicines Agency (EMA). (Although pregnancy was unlikely to occur in this patient population, any patient with childbearing potential had to be withdrawn from the study in the event of pregnancy)
  • Life expectancy >3 months
  • Ability and willingness to give written informed consent

Who cannot join

  • Refractory to platinum-based chemotherapy (defined as remained progressive or became progressive under any previous platinum-based regimen)
  • Progression-free interval of >12 months after the most recent antecedent platinum-based chemotherapy regimen
  • Concomitant anti-tumor therapy or immunotherapy
  • Treatment with monoclonal antibodies or investigational agents ≤30 days before randomization (prior anti-MUC1 therapy was not permitted at any time)
  • Limited-field radiotherapy ≤30 days before randomization (extensive prior radiotherapy during or following the last line of chemotherapy was not permitted; radiotherapy prior to the last line of chemotherapy was permitted)
  • Prior allergic reaction to a monoclonal antibody, Grade 3 IRR or any Grade 4 reaction to a monoclonal antibody
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  • Known sensitivity to any component of the test product
  • Contraindication to the pre-medication used in this study (paracetamol/acetaminophen, H1 and/or H2 receptor antagonists, or steroids)
  • Clinical evidence of brain metastasis or leptomeningeal involvement
  • Patients with second primary cancer, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ, Stage 1 Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years
  • Primary or secondary immune deficiency
  • Clinically active infections >Grade 2 using NCI-CTCAE version 4.0
  • Active hepatitis B or C or infection with human immunodeficiency virus (HIV)
  • Myocardial infarction within 6 months prior to Screening
  • Symptomatic congestive heart failure (New York Heart Association Grade 3 or 4), unstable angina pectoris within 6 months prior to Screening, significant cardiac arrhythmia or history of stroke or transient ischemic attack within 1 year prior to Screening
  • Prior or planned major surgery within 30 days prior to randomization and/or incomplete recovery from prior surgery
  • Concomitant use of systemic steroids, except for inhaled, topical or nasal application within 30 days prior to randomization (steroids used for pre-medication were permitted)
  • Active drug or alcohol abuse
  • Any uncontrolled medical condition that could have put the patient at high risk during treatment with an investigational drug, including unstable diabetes mellitus, vena cava syndrome, or chronic symptomatic respiratory disease
  • Pregnancy or lactation
  • Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons
  • Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous PankoMab-GEX™ administration

Trial locations and contacts

50 sites in 8 countries.

50 sites in 8 countries

Russia12 sites

  • Investigator

    Kazan', 450029

  • Investigator

    Moscow, 111123

  • Investigator

    Moscow, 115478

  • Investigator

    Moscow, 129128

  • Investigator

    Oryol, 302020

  • Investigator

    Pyatigorsk, 357502

  • Investigator

    Rostov-on-Don, 344037

  • Investigator

    Saint Petersburg, 188663

  • Investigator

    Saint Petersburg, 197758

  • Investigator

    Saint Petersburg, 198255

  • Investigator

    Volgograd, 404133

  • Investigator

    Yaroslavl, 150040

Other trials in Russia

Romania8 sites

  • Investigator

    Brasov, 500091

  • Investigator

    Bucharest, 010825

  • Investigator

    Cluj-Napoca, 400015

  • Investigator

    Cluj-Napoca, 400058

  • Investigator

    Craiova, 200347

  • Investigator

    Oradea, 410469

  • Investigator

    Timișoara, 300167

  • Investigator

    Timișoara, 300239

Other trials in Romania

Spain7 sites

  • Investigator

    Barcelona, 08916

  • Investigator

    Madrid, 28007

  • Investigator

    Madrid, 28040

  • Investigator

    Madrid, 28041

  • Investigator

    Madrid, 28046

  • Investigator

    Madrid, 28223

  • Investigator

    Valencia, 46009

Other trials in Spain

Germany6 sites

  • Investigator

    Berlin, 13353

  • Investigator

    Kiel, 24103

  • Investigator

    Munich, 80337

  • Investigator

    Munich, 81675

  • Investigator

    Regensburg, 91054

  • Investigator

    Stuttgart, 70376

Other trials in Germany

Poland6 sites

  • Investigator

    Bydgoszcz, 85796

  • Investigator

    Gdansk, 80402

  • Investigator

    Lublin, 20090

  • Investigator

    Olsztyn, 10513

  • Investigator

    Poznan, 60569

  • Investigator

    Rzeszów, 35242

Other trials in Poland

Italy4 sites

  • Investigator

    Meldola, 47014

  • Investigator

    Milan, 20133

  • Investigator

    Milan, 20141

  • Investigator

    Rome, 00168

Other trials in Italy

United Kingdom4 sites

  • Investigator

    London, SW3 6JJ

  • Investigator

    London, W1T 4TJ

  • Investigator

    Northwood, HA6 2RN

  • Investigator

    Sutton, SM2 5PT

Other trials in United Kingdom

Hungary3 sites

  • Investigator

    Budapest, 1088

  • Investigator

    Debrecen, 4035

  • Investigator

    Szeged, 6720

Other trials in Hungary

About this study

Official title: A Double-blind, Placebo-controlled, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of Maintenance Therapy With PankoMab-GEX™ After Chemotherapy in Patients With Recurrent Epithelial Ovarian Carcinoma

Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian, fallopian tube or primary peritoneal cancer.

Read the detailed description

The study is to evaluate the efficacy of PankoMab-GEX vs Placebo in maintaining response after 2nd to 5th line of chemotherapy in patients with epithelial ovarian or fallopian tube or primary peritoneal cancer. Patients must have responded to platinum based chemotherapy in a previous line, while the response to the most recent Pt-based chemotherapy must not have lasted more than 12 months. In addition the response between most recent 2 lines of chemotherapy prior start of study medication must not have lasted more than 12 months.

Being tested
PankoMab-GEX, Placebo
Keywords
Ovarian Cancer, Maintenance Therapy
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PankoMab-GEXDrug

    Also called Gatipotuzumab

    start dose 500mg at C0D1, maintenance dose 1700mg at CxD1, Number of Cycles: until progression or unacceptable toxicity develops.

  • PlaceboDrug

    start dose matching 500mg at C0D1, maintenance dose matching 1700mg at CxD1, Number of Cycles: until progression or unacceptable toxicity develops.

Study groups in NCT01899599
Study groupRoleWhat they receive
PankoMab-GEXExperimental1700mg, i.v., q3w
Receives: Drug: PankoMab-GEX
PlaceboPlacebo comparatormatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    PFS will be determined by radiographic progression based on modified RECIST 1.1 or death of any cause.

    Measured: from baseline till progression of disease or death

Secondary outcomes (2)

  1. To assess the safety and tolerability of maintenance therapy with single-agent PankoMab-GEX™ compared to placebo in patients with metastatic or recurrent ovarian or fallopian tube carcinoma or primary peritoneal carcinoma.

    Safety will be determined on the occurrence of infusion-related reactions (IRR), treatment emergent adverse events (TEAE) and treatment emergent serious adverse events (TESAE).

    Measured: from randomization until end of treatment

  2. Patient reported outcome

    To evaluate the quality of life (QoL) and other health and health-economy related outcomes

    Measured: from randomization until end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2013 (estimated)
  2. Study startSep 2013
  3. Primary completion20 Apr 2017
  4. Study completion28 Jul 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01899599
Sponsor's protocol ID
GEXMab25201
Other IDs
2013-000931-28
Status last verified
Oct 2020
First submitted
4 Jul 2013
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ledermann JA, Zurawski B, Raspagliesi F, De Giorgi U, Arranz Arija J, Romeo Marin M, Lisyanskaya A, Poka RL, Markowska J, Cebotaru C, Casado Herraez A, Colombo N, Kutarska E, Hall M, Jacobs A, Ahrens-Fath I, Baumeister H, Zurlo A, Sehouli J. Maintenance therapy of patients with recurrent epithelial ovarian carcinoma with the anti-tumor-associated-mucin-1 antibody gatipotuzumab: results from a double-blind, placebo-controlled, randomized, phase II study. ESMO Open. 2022 Feb;7(1):100311. doi: 10.1016/j.esmoop.2021.100311. Epub 2021 Dec 15.

    PubMed 34920291

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PankoMab-GEX in people with Ovarian Epithelial Cancer Recurrent and Fallopian Tube Cancer, run by Glycotope GmbH at 50 sites in 8 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 19 inclusion and 22 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 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Russia, Romania, Spain, Germany, Poland and 3 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Progression free survival (time frame: from baseline till progression of disease or death). 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 NCT01899599, 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 Oct 2020.

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