Epithelial Cancer PatientsPhase 1NCT01320020
A Open Label, Dose Escalating Study to Evaluate the Safety and Tolerability of Ascending Intravenous (i.v.) Doses of Catumaxomab in Epithelial Cancer Patients
A Phase 1 study testing catumaxomab in people with Epithelial Cancer Patients, run by Neovii Biotech at 3 sites in 3 countries.
Trial summary
The study is designed as an open-label dose-escalation study to investigate the safety and tolerability of catumaxomab qwk in patients with epithelial cancer. The treatment period for dose escalation (dose limiting toxicity (DLT) period) consists of 4 weeks, comprising 4 single i.v. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelial Cancer Patients
- What is being tested?
- catumaxomab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2011to Mar 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with epithelial cancer known to have EpCAM overexpression in at least 80% of patients, progressing on or after standard therapy or for whom no standard therapy exists.
- At least one assessable lesion according to RECIST in at least one dimension on computed tomography (CT).
- Life expectancy ≥ 3 months.
- Age ≥ 18 years.
- ECOG Performance Status ≤ 1
- Females of childbearing potential must have a negative serum pregnancy test within 48 hours prior to first infusion of catumaxomab and must use an effective contraception (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release) during the study and at least 13 days after participating in the study.
- Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study has been obtained.
Who cannot join
- Patients with known clinically symptomatic brain metastases.
- Concomitant cancer chemo- or radiotherapy (except for local radiation therapy for bone marrow metastasis)
- Treatment with any investigational product within 4 weeks prior to first administration of catumaxomab
- In cases of previous exposure to cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis) patients must be excluded if not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen).
- Exposure to nitrosoureas or mitomycin C within 6 weeks prior to the first infusion of catumaxomab.
- Abnormal organ or bone marrow function as defined below (any single parameter to fulfill condition):
Show all 16Show fewer
- 6.1. ANC < 1.5 (1.5x109/L, 1500/mm3) 6.2. Hemoglobin < 9.0 g/dL 6.3. Platelet count < 75 (75x109/L, 75,000/mm³) 6.4. AST(SGOT)/ALT(SGPT) > 3 x upper limit of normal (ULN); 6.5. Alkaline phosphatase > 2.5 x ULN 6.6. Serum (total) bilirubin > 1.5 x ULN; 6.7. Serum creatinine > 1.5 x ULN; 6.8. Serum creatinine > 1.5 x ULN (exception: pts on anticoagulant therapy)
- Use of immune-suppressive agents for the past 4 weeks prior to first administration of catumaxomab. For regular use of systemic corticosteroids, patients should only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days prior to first administration of catumaxomab.
- Any known active or chronic infection.
- Known infection with human immunodeficiency virus (HIV positive) and/or hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive).
- Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator.
- Known hypersensitivity to catumaxomab and its analogues in general, or to any other component of the study drug formulation.
- Patients with congestive heart failure NYHA Class III and IV. Cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter, bundle brunch block) or other signs and symptoms of relevant cardiovascular disease.
- Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use effective contraception (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, injections with prolonged release). Effective contraception must be used for the duration of the study and for at least 13 days after participating in the study. Effective contraception must be used by men and women for the duration of the study and for at least 13 days after participating in the study.
- Unwilling or unable to follow protocol requirements.
- Patients with a history of liver cirrhosis
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase I, Open Label, Dose Escalating Study to Evaluate the Safety and Tolerability of Ascending Intravenous (i.v.) Doses of Catumaxomab in Epithelial Cancer Patients
The study is designed as an open-label dose-escalation study to investigate the safety and tolerability of catumaxomab qwk in patients with epithelial cancer. The treatment period for dose escalation (dose limiting toxicity (DLT) period) consists of 4 weeks, comprising 4 single i.v. administrations of catumaxomab followed by 1 week for safety observations after each administration. All patients will be offered continuation of catumaxomab treatment at the same dose until disease progression or death, whichever occurs first.
Read the detailed description
Epithelial cancer patients who are progressing on or after standard therapy or for whom no standard therapy exists. Catumaxomab (trifunctional anti-EpCAM x anti-CD3 antibody)Catumaxomab will be administered i.v. once weekly (qwk) with each infusion lasting for 6 hours. The starting dose for catumaxomab will be 2 µg. The dose escalation schedule is based on a Modified Fibonacci Schedule with the following dose cohorts: 2 µg, 4 µg, 7 µg, 10 µg, 14 µg and 19 µg qwk corresponding to dose increments of 100%, 75%, 43%, 40% and 36% respectively of the previous dose. Subsequent dose levels will correspond to dosing increments of about 30%, e.g. 25, 33, 43, 56 µg. After completion of the DLT period, all patients will be offered continuation of catumaxomab treatment at the same dose until disease progression or death, whichever occurs first. The maximum length of treatment, however, will be restricted to an additional 12 weeks after the DLT period - resulting in a maximum treatment duration of 16 weeks total.
- Conditions
- Epithelial Cancer Patients
- Being tested
- catumaxomab
- Keywords
- Cancer, Neoplasm, Carcinoma, intravenous, Monoclonal Antibody, Removab
- Medical subject headings
- Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catumaxomabDrug
Inter patient dose escalation 2 µg, 4 µg, 7 µg, 10 µg, 14 µg and 19 µg qwk corresponding to dose increments of 100%, 75%, 43%, 40% and 36% respectively of the previous dose
| Study group | Role | What they receive |
|---|---|---|
| catumaxomab | Experimental | Not described Receives: Drug: catumaxomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Tolerated Dose
Measured: The dose escalation schedule is based on a Modified Fibonacci Schedule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Cancer PatientsStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neovii Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josep Tabernero, MD, Study chair, Vall d'Hebron University Hospital, Barcelona, SpainChristian Dittrich, Prim.Univ.-Prof., Principal investigator, Zentrum für Onkologie und Hämatologie, Kaiser Franz Josef-Spital, Wien, AustriaMorten Sorenesen, MD, Ph.D., Principal investigator, The Finsen Center, Department of Oncology, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320020
- Sponsor's protocol ID
- IV-CAT-ST-01
- Status last verified
- May 2013
- First submitted
- 21 Mar 2011
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Dose Escalating Study to Evaluate the Safety and Tolerability of Ascending Intravenous (i.v.) Doses of Catumaxomab in Epithelial Cancer Patients
- ClinicalTrials.gov ID
- NCT01320020
- Acronym / sponsor ID
- IV-CAT-ST-01
- Conditions
- Epithelial Cancer Patients
- Keywords
- Cancer, Neoplasm, Carcinoma, intravenous, Monoclonal Antibody, Removab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Neovii BiotechIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Mar 2011 (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.
The study is designed as an open-label dose-escalation study to investigate the safety and tolerability of catumaxomab qwk in patients with epithelial cancer. The treatment period for dose escalation (dose limiting toxicity (DLT) period) consists of 4 weeks, comprising 4 single i.v. administrations of catumaxomab followed by 1 week for safety observations after each administration. All patients will be offered continuation of catumaxomab treatment at the same dose until disease progression or death, whichever occurs first.
Detailed description
Epithelial cancer patients who are progressing on or after standard therapy or for whom no standard therapy exists. Catumaxomab (trifunctional anti-EpCAM x anti-CD3 antibody)Catumaxomab will be administered i.v. once weekly (qwk) with each infusion lasting for 6 hours. The starting dose for catumaxomab will be 2 µg. The dose escalation schedule is based on a Modified Fibonacci Schedule with the following dose cohorts: 2 µg, 4 µg, 7 µg, 10 µg, 14 µg and 19 µg qwk corresponding to dose increments of 100%, 75%, 43%, 40% and 36% respectively of the previous dose. Subsequent dose levels will correspond to dosing increments of about 30%, e.g. 25, 33, 43, 56 µg. After completion of the DLT period, all patients will be offered continuation of catumaxomab treatment at the same dose until disease progression or death, whichever occurs first. The maximum length of treatment, however, will be restricted to an additional 12 weeks after the DLT period - resulting in a maximum treatment duration of 16 weeks total.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| catumaxomab | Experimental | Drug: catumaxomab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with epithelial cancer known to have EpCAM overexpression in at least 80% of patients, progressing on or after standard therapy or for whom no standard therapy exists.
- At least one assessable lesion according to RECIST in at least one dimension on computed tomography (CT).
- Life expectancy ≥ 3 months.
- Age ≥ 18 years.
- ECOG Performance Status ≤ 1
Key exclusion criteria (16 listed)
- Patients with known clinically symptomatic brain metastases.
- Concomitant cancer chemo- or radiotherapy (except for local radiation therapy for bone marrow metastasis)
- Treatment with any investigational product within 4 weeks prior to first administration of catumaxomab
- In cases of previous exposure to cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis) patients must be excluded if not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen).
- Exposure to nitrosoureas or mitomycin C within 6 weeks prior to the first infusion of catumaxomab.
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 |
|---|---|---|
| catumaxomabInter patient dose escalation 2 µg, 4 µg, 7 µg, 10 µg, 14 µg and 19 µg qwk corresponding to dose increments of 100%, 75%, 43%, 40% and 36% respectively of the previous dose | Drug | catumaxomab |
Primary outcome
Maximal Tolerated Dose
Time frame: The dose escalation schedule is based on a Modified Fibonacci Schedule
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
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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.
Josep Tabernero, MD study chair
Vall d'Hebron University Hospital, Barcelona, Spain
Christian Dittrich, Prim.Univ.-Prof. principal investigator
Zentrum für Onkologie und Hämatologie, Kaiser Franz Josef-Spital, Wien, Austria
Morten Sorenesen, MD, Ph.D. principal investigator
The Finsen Center, Department of Oncology, Rigshospitalet, Copenhagen, Denmark
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing catumaxomab in people with Epithelial Cancer Patients, run by Neovii Biotech at 3 sites in 3 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Denmark, Spain. 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 was stopped early. Results are not available in the source record.
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?
Maximal Tolerated Dose (time frame: The dose escalation schedule is based on a Modified Fibonacci Schedule). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2013.