Ovarian CancerPhase 2NCT00408967
Determine if Either of 2 Doses of Study Drug Given With a Low-dose of Cyclophosphamide After a Complete or Partial Response to a Platinum-based Second-line Therapy in Women With Recurrent Ovarian Carcinoma Results in a Longer Time to Progression When Compared to the First Time to Progression.
A Phase 2 study testing Tucotuzumab celmoleukin (EMD 273066) in people with Ovarian Cancer, run by EMD Serono.
Trial summary
The purpose of this study is to determine if either of two doses of EMD 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Tucotuzumab celmoleukin (EMD 273066)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2006to 31 May 2008
- 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
- Signed written informed consent
- Age 18 years or older
- Have histologically documented ovarian carcinoma (including primary peritoneal carcinoma)
- Have archival tumor tissue available for EpCAM expression determination by immunohistochemistry
- Received first-line platinum-based chemotherapy of up to 8 cycles (approximately 15 to 24 weeks)
- Experienced a complete response to first-line platinum-based chemotherapy
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- Experienced a platinum-free interval of at least 6 but not more than 24 months starting at the end of the last cycle of first-line chemotherapy until recurrence
- Treatment with Avastin (bevacizumab) is permitted during first-line platinum-based chemotherapy through TTP and platinum-based reinduction therapy up to 28 days prior to start of EMD 273066
- Experienced a partial or complete response after up to 8 cycles of second-line platinum-based chemotherapy
- Have a CT/MRI scan within 4 weeks prior to starting treatment
- Be able to start cyclophosphamide and EMD 273066 treatment within 3 to 5 weeks of completion of second-line chemotherapy
- KPS ≥70%
- No clinical history of significantly impaired renal function or chronic kidney disease. Must have an estimated glomerular filtration rate ≥50 mL/min determined by the Cockgroft-Gault-formula
- WBC count ≥2.5x10³/µL (or total granulocytes ≥1x10³/µL)
- Absolute lymphocyte count (ALC) ≥0.5x103/µL
- Platelet count ≥100,000/µL
- Hemoglobin (Hgb) level ≥9 g/dl
- ALT and AST ≤2.5xULN, total bilirubin <1.5xULN
- Serum sodium, potassium and phosphorus within normal limits
- Serum amylase within normal limits
- Serologic testing within 4 weeks prior to starting study treatment with negative results for hepatitis C virus (HCV), human immunodeficiency virus (HIV) and hepatitis B virus (HBV) demonstrated by negative hepatitis B core antibody (HBc Ab) and hepatitis B surface antigen (HbsAg)
- Negative pregnancy test and willingness to use effective contraception for the study duration and 1 month thereafter if of procreative potential
Who cannot join
- Dyspnea at rest, exercise intolerance
- In any subject with clinically significant non-malignant pulmonary disease: Pulmonary function testing (to include Forced Vital Capacity [FVC] and 1-second Forced Expiratory Volume [FEV-1]) showing <70% of predicted values for FVC or FEV-1 and/or DLCO <50%.
- In any subject with pulmonary or pleural metastatic disease: Arterial oxygen saturation at rest measured transcutaneously on room air < 90% or increased risk for respiratory compromise related to IL2 exposure in the judgment of the investigator.
- ECG with evidence of clinically significant disease within 4 weeks prior to starting study treatment
- Cardiac stress test (e.g., exercise or pharmacological thallium test; exercise or pharmacological echocardiography) with abnormal results within 4 weeks prior to starting treatment in subjects who have a history of coronary heart disease (myocardial infarction, angina pectoris or pathologic coronary angiography)
- Any current evidence of congestive heart failure with NY Heart Association Grade 2 through 4 or echocardiogram with a left ventricular ejection fraction <45% or other signs of clinical significant heart disease
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- History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other clinically significant arrhythmias
- Evidence of active brain metastases
- Previous malignancy other than ovarian cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix
- Pregnant or lactating female
- An immediate need for palliative radiotherapy or systemic corticosteroid therapy
- Significant active infection
- Major surgery, chemotherapy, or radiation within 21 days of starting study treatment
- Received another experimental drug within 28 days of starting study treatment
- Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg) or hypotension (systolic ≤90 mmHg)
- Presence of medically significant third space fluids such as pleural or pericardial effusions or edema of toxicity grade ≥2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 [17].
- Exception allowed for disease-related peritoneal ascites unless patient requires frequent and repetitive paracentesis management.
- Previous diagnosis of an autoimmune disease involving a major organ system
- Transplant recipient on immunosuppressive therapy
- Acute esophageal or gastroduodenal ulcers
- History of prior therapy or a serious uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study
About this study
Official title: An Open-label Phase II Study of Two Dose Levels of EMD 273066 Administered With Low-dose Cyclophosphamide Following Objective Response to Second-line Chemotherapy in Women With Recurrent Ovarian Carcinoma
The purpose of this study is to determine if either of two doses of EMD 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression
- Conditions
- Ovarian Cancer
- Being tested
- Tucotuzumab celmoleukin (EMD 273066)
- Keywords
- Ovarian, Cancer, Epithelial, Recurrent, Platinum, Second-line therapy, Maintenance Therapy, Biologic, Targeted Therapy, Antibody
- Medical subject headings
- Ovarian Neoplasms, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tucotuzumab celmoleukin (EMD 273066)Drug
| Study group | Role | What they receive |
|---|---|---|
| Tucotuzumab celmoleukin (EMD 273066) | Experimental | Not described Receives: Drug: Tucotuzumab celmoleukin (EMD 273066) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study start31 Dec 2006
- Primary completion31 May 2008
- Study completion31 May 2008
Why it stopped: Th trial got cancelled and no subjects signed informed consent form (ICF); study design not appropriate any longer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408967
- Sponsor's protocol ID
- EMR 62206-016
- Status last verified
- Aug 2017
- First submitted
- 6 Dec 2006
- Last updated
- 18 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase II Study of Two Dose Levels of EMD 273066 Administered With Low-dose Cyclophosphamide Following Objective Response to Second-line Chemotherapy in Women With Recurrent Ovarian Carcinoma
- ClinicalTrials.gov ID
- NCT00408967
- Acronym / sponsor ID
- EMR 62206-016
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian, Cancer, Epithelial, Recurrent, Platinum, Second-line therapy, Maintenance Therapy, Biologic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Th trial got cancelled and no subjects signed informed consent form (ICF); study design not appropriate any longer.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2006 (actual)
- Primary completion
- 31 May 2008 (actual)
- Study completion
- 31 May 2008 (actual)
- First posted
- 8 Dec 2006 (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 purpose of this study is to determine if either of two doses of EMD 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucotuzumab celmoleukin (EMD 273066) | Experimental | Drug: Tucotuzumab celmoleukin (EMD 273066) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Signed written informed consent
- Age 18 years or older
- Have histologically documented ovarian carcinoma (including primary peritoneal carcinoma)
- Have archival tumor tissue available for EpCAM expression determination by immunohistochemistry
- Received first-line platinum-based chemotherapy of up to 8 cycles (approximately 15 to 24 weeks)
Key exclusion criteria (21 listed)
- Dyspnea at rest, exercise intolerance
- In any subject with clinically significant non-malignant pulmonary disease: Pulmonary function testing (to include Forced Vital Capacity [FVC] and 1-second Forced Expiratory Volume [FEV-1]) showing <70% of predicted values for FVC or FEV-1 and/or DLCO <50%.
- In any subject with pulmonary or pleural metastatic disease: Arterial oxygen saturation at rest measured transcutaneously on room air < 90% or increased risk for respiratory compromise related to IL2 exposure in the judgment of the investigator.
- ECG with evidence of clinically significant disease within 4 weeks prior to starting study treatment
- Cardiac stress test (e.g., exercise or pharmacological thallium test; exercise or pharmacological echocardiography) with abnormal results within 4 weeks prior to starting treatment in subjects who have a history of coronary heart disease (myocardial infarction, angina pectoris or pathologic coronary angiography)
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 |
|---|---|---|
| Tucotuzumab celmoleukin (EMD 273066) | Drug | Tucotuzumab celmoleukin (EMD 273066) |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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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.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tucotuzumab celmoleukin (EMD 273066) in people with Ovarian Cancer, run by EMD Serono.
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 22 inclusion and 21 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: withdrawn, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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.
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 18 Aug 2017.