CY-503 for the Treatment of Chemotherapy-refractory Metastatic Colorectal Cancer (CY503C2)

This study is currently recruiting participants.

Verified June 2011 by Cytavis Biopharma GmbH

Sponsor:

Collaborators:

ClinAssess GmbH

Medizinische Univ. Insbruck - Koordinierungszentrum für Klinische Studien (KKS)

Charite University, Berlin, Germany

Information provided by:

Cytavis Biopharma GmbH

ClinicalTrials.gov Identifier:

NCT00932724

First received: June 25, 2009

Last updated: June 7, 2011

Last verified: June 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Metastatic Colorectal Cancer	Drug: CY-503 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Phase II Double-blind Placebo-controlled Trial of CY503 in Patients With Chemotherapy-refractory Metastatic Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Cytavis Biopharma GmbH:

Primary Outcome Measures:

Tumor assessment by using CT scans and/or MRIs [ Time Frame: every 8 weeks (each 2 cycles) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of Adverse Events [ Time Frame: every 4 weeks (every cycle) ] [ Designated as safety issue: Yes ]
Assessment of quality of life using a standardized questionaire [ Time Frame: every 4 weeks (every cycle) ] [ Designated as safety issue: No ]
Assessment of survival by "physical exam" [ Time Frame: every 4 weeks (every cycle) / every 3 months during follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CY-503	Drug: CY-503 Ampoules with 1 ml 350 ng CY-503 solution for s.c. injection twice weekly. One cycle is defined as 4 consecutive weeks
Placebo Comparator: Placebo	Drug: Placebo Ampoules with 1 ml placebo solution for s.c. injection twice weekly. One cycle is defined as 4 consecutive weeks

Detailed Description:

Colorectal cancer has a worldwide annual incidence of approximately 1 million new cases diagnosed yearly and it is the second leading cause of cancer-related death in Western nations. There are a couple of approved standard therapies for the treatment of MCRC with cytotoxic agents irinotecan, oxaliplatin, and the fluoropyrimidines , as well as bevacizumab, the antibody against vascular endothelial growth factor A, and cetuximab, the antibody against the epidermal growth factor receptor. But there are only a few studies achieving a median survival time of more than 20 months in MCRC patients with standard regimens. After a 1st line therapy a high proportion (50% to 80%) of patients receives a 2nd line therapy with drugs not used in 1st line therapy and a part of them gets a 3rd line treatment. Results from a 2nd line therapy are best response rates ranging from 4 % - 23 %, a median PFS rate of 5.1 months, a median TTP of 4.1 - 4.6 months and median overall survival 6.9 - 12 months. However, for patients who experience disease progression after standard therapy (definition see inclusion criteria) there is no further standard therapeutic option. These patients developed a resistance to these therapies and finally die of their disease. They generally get best supportive care (BSC). Thus, there is a need for new active treatment options in this setting.

In this phase II double-blind placebo-controlled trial the efficacy and safety of CY-503, 350 ng s.c. injected in patients with chemotherapy refractory MCRC are tested. Approved treatments given to MCRC patients are usually discontinued after a treatment over some weeks at the first detection of objective PD. It will be tested if CY-503 is able to achieve progression-free-survival (PFS) in comparison to placebo. Patients will initially be included to receive either CY-503 or placebo until documentation of objective PD.

Standard therapy must be finished and has shown objective PD. Also patients with contraindications to standard therapy can be included.

CY-503 shows the potential to improve treatment of MCRC. This study aims at evaluating the activity and therapeutic effects of the substance. Anticipated capabilities are substitution of cytostatic drugs or improvement of their efficacy and tolerability . Furthermore, the expected improvement of PFS rates after failure of standard chemotherapies has to be investigated.

In a phase I trial CY-503 showed SD in patients who had exhausted standard therapy options for metastatic disease with subsequent disease progression with a median TTP of 17.4 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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
Bilirubin ≤ 2.0 mg/dL (40 μmol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be ≤3.5 mg/dL (59.86 μmol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 5 × upper limit of normal (ULN); hepatic alkaline phosphatase ≤ 3.0 × ULN (in case of liver metastases higher levels do not hinder inclusion of patients)
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

Exclusion Criteria:

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
Use of conventional mistletoe preparations, any immunostimulating substances and/or monoclonal antibodies within four weeks prior to and during the trial - ongoing therapy with steroids is permitted if the dose is not higher than 20 mg of prednisone-equivalent at the time of inclusion and during this clinical trial
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932724

Locations

Austria
Bezirkskrankenhaus Hall	Recruiting
Hall in Tirol, Austria, 6060
Contact: Hannes Gänzer, Uni. Doz. MD 05223-502-0 johannes.gaenzer@bkh-hall.or.at
Principal Investigator: Hannes Gänzer, Uni. Doz. MD
Sub-Investigator: Horst Oexle, MD
Sub-Investigator: Judith Hager, MD
Sub-Investigator: Romana Mair, MD
Sub-Investigator: Helga Grömer, MD
Sub-Investigator: Alice Markl
Sub-Investigator: Sieglinde Wild, MD
Medizinische Universität Innsbruck	Recruiting
Innsbruck, Austria, 6020
Contact: Wolfgang Eisterer, Prof. MD 0043512-504-23333 Wolfgang.Eisterer@i-med.ac.at
Principal Investigator: Wolfgang Eisterer, Prof. MD
Sub-Investigator: Oliver Bechter, Univ.-Doz. MD
Sub-Investigator: Georg Pall, MD
Sub-Investigator: Marie-Therese Kasseroler, MD
Sub-Investigator: Heinz Zwierzina, Univ.-Prof. MD
Bezirkskrankenhaus Kufstein	Recruiting
Kufstein, Austria, 6330
Contact: August Zabernigg, MD 05372-6966-3001 august.zabernigg@bkh-kufstein.at
Principal Investigator: August Zabernigg, MD
Sub-Investigator: Christina Bernhard, MD
Sub-Investigator: Klaus Gattringer, Univ.-Prof. MD
Sub-Investigator: Doris Hintner, MD
St. Vinzenz Krankenhaus Zams	Recruiting
Zams, Austria, 6511
Contact: Ewald Wöll, Uni. Doz. MD 05442-600-7413 e.woell@krankenhaus-zams.at
Principal Investigator: Ewald Wöll, Uni. Doz. MD
Sub-Investigator: Ruth Scheiber, MD
Sub-Investigator: Günther Zangerl, MD
Germany
Klinikum Altenburger Land GmbH	Recruiting
Altenburg, Germany, 04600
Contact: Armin Schulz-Abelius, Dr. med. 03447-52-2353 inH@klinikum-altenburgerland.de
Sub-Investigator: Kai Friedrichsen, MD
Sub-Investigator: Romy Pomper
Principal Investigator: Armin Schulz-Abelius, MD
Gesundheitszentrum St. Marien GmbH am Klinikum St. Marien	Recruiting
Amberg, Germany, 922224
Contact: Ludwig Fischer v. Weikersthal, MD +499621381637 weikersthal.ludwig@klinikum-amberg.de
Principal Investigator: Ludwig Fischer v. Weikersthal, MD
Sub-Investigator: Robert Funck, MD
Studienzentrum f. Hämatologie, Onkologie u. Diabetologie	Recruiting
Aschaffenburg, Germany, 63739
Contact: Manfred Welslau, MD 06021-3427-80 info@studien-zentrum.de
Sub-Investigator: Martine Klausmann, MD
Sub-Investigator: Stefanie Deppisch, MD
Principal Investigator: Manfred Welslau, MD
Klinikum Bayreuth	Recruiting
Bayreuth, Germany, 95445
Contact: Christoph Stoll, MD +499214006310 christoph.stoll@klinkum-bayreuth.de
Principal Investigator: Christoph Stoll, MD
Sub-Investigator: Claudia Pfeiffer, MD
Klinikum Dortmund GmbH	Recruiting
Dortmund, Germany, 44137
Contact: Sabine Bäumer, MD +49 231 953 20780 sabine.baeumer@klinikumdo.de
Principal Investigator: Sabine Bäumer, MD
Sub-Investigator: Michael Heike, Prof., MD
Sub-Investigator: Peter Boris Czyborra, MD
Sub-Investigator: Silke Götte
Universitätsklinik Dresden	Recruiting
Dresden, Germany, 01307
Contact: Gunnar Folprecht, MD +49351449210629 Gunnar.Folprecht@uniklinikum-dresden.de
Principal Investigator: Gunnar Folprecht, MD
Sub-Investigator: Anke Frömmel, MD
Sub-Investigator: Jan Stöhlmacher, MD
Sub-Investigator: Eray Goekkurt, MD
Sub-Investigator: Karolin Trautmann-Grill, MD
Sub-Investigator: Heinrich Günther, MD
Sub-Investigator: Susanne Hamann, MD
Sub-Investigator: Anke Müthering
Sub-Investigator: Jenny Neuhäußer
Westdeutsches Tumorzentrum - Universitätsklinikum Essen	Recruiting
Essen, Germany, 45147
Contact: Max Scheulen, Prof., MD +492017233790 mas.scheulen@uk-essen.de
Principal Investigator: Max Scheulen, Prof., MD
Sub-Investigator: Bahar Nokay
Sub-Investigator: Heike Richly, MD
Sub-Investigator: Andreas-Claudius Hoffmann, MD
Klinikum Esslingen	Recruiting
Esslingen, Germany, 7370
Contact: Michael Geißler, Prof., MD +49711310382450 m.geissler@klinikum-es.de
Principal Investigator: Michael Geißler, Prof., MD
Sub-Investigator: Caroline Hörner, MD
Sub-Investigator: Heike Karin Mönnich, MD
MVZ Onkologische Schwerpunktpraxis	Recruiting
Frankfurt, Germany, 60596
Contact: Hans-Jörg Cordes, MD +49650073200 info@ifs-frankfurt.de
Principal Investigator: Hans-Jörg Cordes, MD
Sub-Investigator: Regina Claude, MD
Sub-Investigator: Stella Hermann, MD
Klinikum der Johann Wolfgang-Universität Frankfurt	Recruiting
Frankfurt a.M., Germany, 60590
Contact: Lothar Bergmann, Prof., MD +496963015124 l.bergmann@em.uni-frankfurt.de
Principal Investigator: Lothar Bergmann, Prof., MD
Sub-Investigator: Shabnam Shaid, MD
Sub-Investigator: Luise Maute, MD
Sub-Investigator: Soo-Zin Kim-Wanner, MD
Sub-Investigator: Valeska Möntenich
Sub-Investigator: Daniel Stanze, MD
Martin-Luther Universität Halle	Recruiting
Halle/Saale, Germany, 06120
Contact: Hans-Joachim Schmoll, Prof. MD 0345-5572924 hans-joachim.schmoll@medizin.uni-halle.de
Principal Investigator: Hans-Joachim Schmoll, Prof. MD
Sub-Investigator: Jörn Rüssel
Sub-Investigator: Timo Behlendorf
Sub-Investigator: Kati Sudau, MD
Onkologische Schwerpunktpraxis	Recruiting
Hamburg, Germany, 20249
Contact: Susanne Hegewisch-Becker, Prof., MD +49404602001 hegewisch@t-online.de
Principal Investigator: Susanna Hegewisch-Becker, Prof., MD
Sub-Investigator: Michael Begemann, MD
Sub-Investigator: Thorsten Dierlamm, MD
Universitätsklinkum Heidelberg - Nationales Centrum f. Tumorerkrankungen	Recruiting
Heidelberg, Germany, 69120
Contact: Mareike Dietrich, MD mareike.dietrich@med.uni-heidelberg.de
Principal Investigator: Mareike Dietrich, MD
Sub-Investigator: Leonidas Apostolidis, MD
Sub-Investigator: Christian Suppan, MD
Sub-Investigator: Guy Ungerechts, MD
Sub-Investigator: Michael Schmitz, MD
Sub-Investigator: Stephan Nachtigall, MD
Sub-Investigator: Stefan Ezechiel Welte, MD
Sub-Investigator: Klaus Podar, PD MD
Sub-Investigator: Karl Roland Ehrenberg, MD
Marienhospital Herne	Recruiting
Herne, Germany, 44625
Contact: Dirk Strumberg, PD, MD +4923234991641 dirk.strumberg@marienhospital-herne.de
Principal Investigator: Dirk Strumberg, PD, MD
Sub-Investigator: Gerhard Kurt Kummer, MD
Sub-Investigator: Beate Schultheis, MD
Onkologische Schwerpunktpraxis	Recruiting
Hildesheim, Germany, 31135
Contact: Werner Freier, MD +4951219129140 dr.freier@onkologie-hildesheim.de
Principal Investigator: Werner Freier, MD
Sub-Investigator: Bernd Sievers, MD
Onkologische Schwerpunktpraxis	Recruiting
Hof, Germany, 95028
Contact: Hanns D Harich, MD +499281540060 praxis.harich.kasper@web.de
Principal Investigator: Hanns D Harich, MD
Sub-Investigator: Christian Kasper, MD
Praxis für Hämatologie und internistische Onkologie	Recruiting
Kronach, Germany, 96317
Contact: Martina Stauch, MD +49 9261 6248 ext 0 praxisdrstauch@t-online.de
Principal Investigator: Martina Stauch, MD
Praxis Onkologie	Recruiting
Köln, Germany, 51103
Contact: Lutz Dietze, MD 0221-98944717 dietze@netcologne.de
Principal Investigator: Lutz Dietze, MD
Sub-Investigator: Dieter Mainka, MD
Klinikum der Stadt Ludwigshafen	Recruiting
Ludwigshafen, Germany, 67063
Contact: Ralf Jakobs, Prof. MD 0621 503 4100 jakobsr@klilu.de
Sub-Investigator: Rico Hochdörffer, MD
Sub-Investigator: Friedrich Schorr, MD
Sub-Investigator: Matthias Bechtler, MD
Sub-Investigator: Johannes Striegel, MD
Principal Investigator: Ralf Jakobs, Prof. MD
Klinikum Lüdenscheid	Recruiting
Luedenscheid, Germany, 58515
Contact: Gerhard Heil, Prof., MD +492351463539 gerhard.heil@klinikum-luedenscheid.de
Principal Investigator: Gerhard Heil, Prof., MD
Sub-Investigator: Stephanie Schirp
Sub-Investigator: Serap Gülüc
Sub-Investigator: Ute-Marie von Pein, MD
Klinikum Magdeburg gGmbH	Recruiting
Magdeburg, Germany, 39130
Contact: Christoph Kahl, PD MD 0391-791-5640 christoph.kahl@klinikum-magdeburg.de
Principal Investigator: Christoph Kahl, PD MD
Sub-Investigator: Carsten Roll, MD
Sub-Investigator: Karsten Ridwelski, Prof. MD
Sub-Investigator: Stephan Rudolph, MD
Sub-Investigator: Norbert Schmidt, MD
Sub-Investigator: Maria Klarfeld
Johanness-Gutenberg Universität Mainz	Recruiting
Mainz, Germany, 55101
Contact: Markus Möhler, PD, MD +496131176863 moehler@mail.uni-mainz.de
Principal Investigator: Markus Möhler, PD, MD
Sub-Investigator: Carl Christoph Schimanski, PD, MD
Sub-Investigator: Frank Staib, MD
Sub-Investigator: Marcus-Alexander Wörns, MD
Praxis für Hämatologie und internistische Onkologie	Recruiting
München, Germany, 80638
Contact: Oliver J. Stötzer, MD +498913958588 ojstoetzer@aol.com
Principal Investigator: Oliver J. Stötzer, MD
Gemeinschaftspraxis f. Hämatologie u. Onkologie	Recruiting
Münster, Germany, 48149
Contact: Christian Lerchenmüller, MD 0251-62008-15 lerchenmueller@onkologie-muenster.de
Sub-Investigator: Jürgen Wehmeyer, MD
Sub-Investigator: Karsten Kratz-Albers, MD
Sub-Investigator: Holger Timmer, MD
Sub-Investigator: Ralf Bieker, MD
Principal Investigator: Christian Lerchenmüller, MD
Studienzentrum Onkologie Ravensburg	Recruiting
Ravensburg, Germany, 88212
Contact: Thomas Decker, PD, MD 0751/366197-0 decker@onkonet.eu
Principal Investigator: Thomas Decker, PD, MD
Sub-Investigator: Martina Herbrick-Zipp, MD
Sub-Investigator: Christoph Nonnenbroich, MD
Prosper-Hospital	Recruiting
Recklinghausen, Germany, 45657
Contact: Michael Klein, MD 02361-54-2650 oder -540
Sub-Investigator: Thomas Höhler, Prof., MD
Sub-Investigator: Claudia Baller
Principal Investigator: Micheal Klein, MD
Sub-Investigator: Martina Höher
Sub-Investigator: Irahim Musa
Universitätsklinikum Ulm	Recruiting
Ulm, Germany, 89081
Contact: Gätz v. Wichert, PD, MD +497315004450508 goetz.wichert@uniklinikum-ulm.de
Principal Investigator: Götz v. Wichert, PD, MD
Sub-Investigator: Johann Ahn, MD
Sub-Investigator: Jochen Klaus, MD
Sub-Investigator: Sven Walter, MD
Sub-Investigator: Nadine Schulte, MD
Sub-Investigator: Angelika M.R. Kestler, MD
Klinikum Nordoberpfalz AG	Recruiting
Weiden Oberpfalz, Germany, 92637
Contact: Frank Kullmann, Prof., MD +499613030 frank.kullmann@kliniken-nordoberpfalz.ag
Principal Investigator: Frank Kullmann, Prof., MD
Sub-Investigator: Swetlana Zimmermann
Sub-Investigator: Sonja Pampuch, MD
Sub-Investigator: Simona Miruna Kocher
Sub-Investigator: Holger Tuchbreiter

Sponsors and Collaborators

Cytavis Biopharma GmbH

ClinAssess GmbH

Medizinische Univ. Insbruck - Koordinierungszentrum für Klinische Studien (KKS)

Charite University, Berlin, Germany

Investigators

Principal Investigator:	Heinz Zwierzina, MD	University Hospital Innsbruck, Austria
Principal Investigator:	Lothar Bergmann, MD	University Hospital Frankfurt, Germany

More Information

No publications provided

Responsible Party:	Prof. Hans Lentzen, PhD, Cytavis Biopharma GmbH
ClinicalTrials.gov Identifier:	NCT00932724 History of Changes
Other Study ID Numbers:	CY503C2, EudraCT no. 2008-005536-32
Study First Received:	June 25, 2009
Last Updated:	June 7, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Austria: Agency for Health and Food Safety

Keywords provided by Cytavis Biopharma GmbH:

Metastatic
Colorectal
Cancer
refractory
Phase II
randomised

double-blind
controlled
multicenter
CY-503
Cytavis

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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