Study Stopped
The sponsor declared the early termination of the study due to poor recruitment of patients.
CY-503 for the Treatment of Chemotherapy-refractory Metastatic Colorectal Cancer
CY503C2
Phase II Double-blind Placebo-controlled Trial of CY503 in Patients With Chemotherapy-refractory Metastatic Colorectal Cancer
2 other identifiers
interventional
77
2 countries
33
Brief Summary
This trial is designed as a phase II evaluation of the effect of CY-503 or placebo on progression free survival (PFS) defined as the time from start of treatment until the objective observation of progressive disease (PD) or death from any course in patients with chemotherapy-refractory metastatic colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2009
Typical duration for phase_2
33 active sites
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
June 25, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJuly 10, 2013
June 1, 2011
3.1 years
June 25, 2009
July 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor assessment by using CT scans and/or MRIs
every 8 weeks (each 2 cycles)
Secondary Outcomes (3)
Assessment of Adverse Events
every 4 weeks (every cycle)
Assessment of quality of life using a standardized questionaire
every 4 weeks (every cycle)
Assessment of survival by "physical exam"
every 4 weeks (every cycle) / every 3 months during follow-up
Study Arms (2)
CY-503
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Patients are eligible with diagnosis of measurable metastatic colorectal carcinoma and radiologic documentation of disease progression during or with 3 months after termination of standard chemotherapy (fluoropyrimidine-based therapy with oxaliplatin and irinotecan). Patients who had to interrupt the 1st or 1nd line therapy due to intolerance or who were refractory or intolerant to the standard treatment regimens are eligible, too. Bevacizumab can, but does not need to be administered at discretion of treating physician. Patients with K-RAS wild-type can be treated with cetuximab or panitumumab before they enter the study.
- No chemotherapy within 4 weeks before treatment start
- No residual significant toxicity (greater than NCI grade 1), in case of peripheral neuropathy: no symptoms of peripheral neuropathy of NCI CTC grade 4 within 4 weeks before treatment start.
- No previous treatment with experimental therapies after standard therapies is allowed.
- Patients must use effective contraception if of reproductive potential. Females must not be pregnant or lactating
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 2
- WBC ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥100,000/mm3
- Serum creatinine ≤ 2.0 mg/dL (180 μmol/L)or creatinine clearance \>= 50 ml/min. , proteinuria \< 2.0 g/24 hr urine collection in patients with a positive urine dipstick for protein
- Written informed consent according to ICH-GCP and national laws and regulations prior to receipt of any trial medication or beginning trial procedures
You may not qualify if:
- Evidence of any other malignant disease (with the exception of tumors operatively cured at least 5 years prior to the trial)
- Known brain metastases
- Uncontrolled pleural effusions
- Interstitial pneumonitis or pulmonary fibrosis
- Severe/ unstable systemic disease or infection and circumstances not permitting trial participation (e.g., alcoholism or substance abuse)
- Unstable cardiac disease in the last 6 months
- Any evidence or history (elicited by the investigator) of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to randomization
- Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., marcumar or heparin)
- History of hypersensitivity to mistletoe
- History of primary immunodeficiency
- Known human immunodeficiency virus (HIV) or known active viral hepatic infections
- Prior treatment with CY-503
- A general medical or psychological condition or behaviour, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the trial or sign the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cytavis Biopharma GmbHlead
- ClinAssess GmbHcollaborator
- Medical University Innsbruckcollaborator
- Charite University, Berlin, Germanycollaborator
Study Sites (33)
Bezirkskrankenhaus Hall
Hall in Tirol, 6060, Austria
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Bezirkskrankenhaus Kufstein
Kufstein, 6330, Austria
St. Vinzenz Krankenhaus Zams
Zams, 6511, Austria
Klinikum Altenburger Land GmbH
Altenburg, 04600, Germany
Gesundheitszentrum St. Marien GmbH am Klinikum St. Marien
Amberg, 922224, Germany
Studienzentrum f. Hämatologie, Onkologie u. Diabetologie
Aschaffenburg, 63739, Germany
Klinikum Bayreuth
Bayreuth, 95445, Germany
Praxis Onkologie
Cologne, 51103, Germany
Klinikum Dortmund GmbH
Dortmund, 44137, Germany
Universitätsklinik Dresden
Dresden, 01307, Germany
Westdeutsches Tumorzentrum - Universitätsklinikum Essen
Essen, 45147, Germany
Klinikum Esslingen
Esslingen am Neckar, 7370, Germany
MVZ Onkologische Schwerpunktpraxis
Frankfurt, 60596, Germany
Klinikum der Johann Wolfgang-Universität Frankfurt
Frankfurt a.M., 60590, Germany
Martin-Luther Universität Halle
Halle, 06120, Germany
Onkologische Schwerpunktpraxis
Hamburg, 20249, Germany
Universitätsklinkum Heidelberg - Nationales Centrum f. Tumorerkrankungen
Heidelberg, 69120, Germany
Marienhospital Herne
Herne, 44625, Germany
Onkologische Schwerpunktpraxis
Hildesheim, 31135, Germany
Onkologische Schwerpunktpraxis
Hof, 95028, Germany
Praxis für Hämatologie und internistische Onkologie
Kronach, 96317, Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, 67063, Germany
Klinikum Lüdenscheid
Lüdenscheid, 58515, Germany
Klinikum Magdeburg gGmbH
Magdeburg, 39130, Germany
Johanness-Gutenberg Universität Mainz
Mainz, 55101, Germany
Praxis für Hämatologie und internistische Onkologie
München, 80638, Germany
Gemeinschaftspraxis f. Hämatologie u. Onkologie
Münster, 48149, Germany
Studienzentrum Onkologie Ravensburg
Ravensburg, 88212, Germany
Prosper-Hospital
Recklinghausen, 45657, Germany
Onkologische Schwerpunktpraxis, Hämatologie und Onkologie
Trier, 54292, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Klinikum Nordoberpfalz AG
Weiden Oberpfalz, 92637, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heinz Zwierzina, MD
University Hospital Innsbruck, Austria
- PRINCIPAL INVESTIGATOR
Lothar Bergmann, MD
University Hospital, Frankfurt, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 25, 2009
First Posted
July 3, 2009
Study Start
July 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
July 10, 2013
Record last verified: 2011-06