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Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma (IMPACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mologen AG
ClinicalTrials.gov Identifier:
NCT01208194
First received: August 27, 2010
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC Stage IV) with disease control after first-line standard chemotherapy regimens.


Condition Intervention Phase
Advanced Colorectal Carcinoma
Drug: MGN1703
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma With Disease Control After Initial First-line Therapy

Resource links provided by NLM:


Further study details as provided by Mologen AG:

Primary Outcome Measures:
  • Evaluation of median progression-free survival (PFS) in both treatment groups [ Time Frame: Measured on accrual time 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of PFS rate [ Time Frame: Measured at landmarks 12, 18 and 24 weeks after treatment start, and afterwards every 6 weeks until treatment stop ] [ Designated as safety issue: No ]
  • Evaluation of median overall survival (OS) [ Time Frame: Measured on accrual time 3 years ] [ Designated as safety issue: No ]
  • Assessment of OS proportion in both groups [ Time Frame: Measured at landmarks 12, 18 and 24 weeks after treatment start, and afterwards every 6 weeks until treatment stop ] [ Designated as safety issue: No ]
  • Evaluation of overall response rate (ORR) [ Time Frame: Measured on accrual time 3 years ] [ Designated as safety issue: No ]
  • Evaluation of duration of response (complete response, partial response, stable disease) as time from initial determination of response to progressive disease measured by RECIST [ Time Frame: Measured on accrual time 3 years ] [ Designated as safety issue: No ]
  • Assessment of the dynamic of clinical and laboratory parameters [ Time Frame: An average time: participants are followed until progress ] [ Designated as safety issue: No ]
  • Evaluation of immunologic response to MGN1703 [ Time Frame: An average time: participants are followed until progress ] [ Designated as safety issue: No ]
  • Assessment of quality of life (QOL) [ Time Frame: An average time: participants are followed until progress ] [ Designated as safety issue: No ]
  • Assessment of the safety profile of MGN1703 [ Time Frame: An average time: participants are followed until progress ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MGN1703
Study medication
Drug: MGN1703
solution, 60 mg, twice a week, until progression
Other Name: immunomodulator
Placebo Comparator: Placebo Drug: Placebo
solution, 60 mg, twice a week, until progression
Other Name: Placebo

Detailed Description:

The phase 2 study will be conducted in patients with advanced colorectal carcinoma with disease control after first-line standard chemotherapy regimens with oral or intravenous fluoropyrimidines/leucovorin and irinotecan or oxaliplatin combined with a standard dose of bevacizumab lasted between 4.5 and 6 months, whereas the treatment duration with irinotecan or oxaliplatin should not be less than 3 months. Studies confirmed that completely chemotherapy-free intervals can be applicable in patients with advanced colorectal carcinoma who achieved disease control after initial first-line chemotherapy. Those therapy holidays minimize toxicity and unnecessary treatment load, reduce intensity of treatment, allow patients to stay longer on therapy, prevent therapy discontinuations due to toxicity, preserve the ability to re-administer chemotherapy later, and increase quality of life of the patients. The therapy-free interval represents a possibility to evaluate the efficacy of the study drug, MGN1703.

  Eligibility

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

Inclusion Criteria:

  • Male and female subjects older than 18 years of age
  • Histologically confirmed colorectal carcinoma
  • Radiological confirmation of unresectable advanced colorectal carcinoma (AJCC Stage IV) prior to start of initial first-line therapy
  • At least one measurable lesion according to RECIST measured within 2 weeks prior to treatment start in case of partial response or stable disease
  • Prior initial first-line therapy included oral or intravenous fluoropyrimidines/leucovorin,irinotecan or oxaliplatin with or without a standard dose of bevacizumab lasted between 4.5 and 6 months and finished (last day of last cycle) within 2 weeks prior to treatment start (treatment duration with irinotecan or oxaliplatin should not be less than 3 months)
  • Patients who achieved disease control measured as objective response or disease stabilization after initial first-line therapy
  • No curative standard therapy is available for the patient after first-line treatment
  • ECOG performance status 0-1
  • Adequate organ function, hemoglobin ≥ 9 g/L, white blood cell count (WBC) ≥ 3.0 x 109/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets > 100 x109/L, aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN, bilirubin < 1.5 x ULN, blood creatinine ≤ 1.5 X ULN, prothrombin time (PT) and activated thromboplastin time (aPTT) within normal range
  • Negative pregnancy test in women with childbearing potential
  • Expected adequacy of follow-up
  • Signed informed consent form (ICF)

Exclusion Criteria:

  • More than one line of systemic chemotherapy for metastatic colorectal carcinoma
  • Tumor progression after initial first-line therapy
  • Clinically significant concomitant diseases or conditions, which in opinion of the investigator would lead to an unacceptable risk for the subject to participate in the study
  • Prior or current other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin or other cancer for which the subject has been disease free for more than 3 years
  • Known central nervous system metastases
  • Active or uncontrolled infections
  • Transfusion-dependent anemia
  • History of autoimmune disease or immune deficiency
  • Known hypersensitivity to oligonucleotides or excipients of the formulation
  • Pregnancy and/or nursing
  • Concurrent chronic systemic immune therapy or immunosuppressant medication, including steroid treatment
  • Concurrent chemotherapy, hormonal therapy (except hormonal contraception and hormonal replacement therapy for menopausal women), or immunotherapy within the last 2 weeks prior to randomization or during the conduct of the study - Concurrent radiotherapy within the last 6 months prior to randomization or during the conduct of the study
  • Known HIV seropositivity or active hepatitis B or C infection
  • Planned major surgery during the study
  • Participation in another clinical study with other investigational drugs within 30 days prior to the first treatment day
  • Vaccination within 3 months prior to the first treatment day
  • Any medical, mental, psychological or psychiatric condition which in opinion of the investigator would not permit the subject to complete the study or understand the patient information
  • Presence of drug and/or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208194

Locations
Austria
Klinik für Innere Medizin I, Abteilung für Klinische Onkologie, Medizinische Universität Wien
Wien, Austria, 1090
Czech Republic
Oncology Clinic, Faculty Hospital Olomouc
Olomouc, Czech Republic, 77520
France
Service de Cancérologie Digestive, Institut de Cancérologie Gustave Roussy
Villejuif, France, 94805
Germany
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany, 14195
Klinik für Innere Medizin IV, Onkologie/ Hämatologie/ Hämostaseologie, Universitätsklinikum Halle (Saale)
Halle, Germany, 06120
Kath. Marienkrankenhaus GmbH, Allgemeine Onkologie
Hamburg, Germany, 22087
Schwerpunktpraxis für Hämatologie und Onkologie
Magdeburg, Germany, 39104
Klinik für Innere Medizin, Klinik für Hämatologie, Onkologie, Immunologie, Universitätsklinikum Giessen und Marburg GmbH
Marburg, Germany, 35043
Medizinische Klinik, Abteilung für Onkologie, Hämatologie Immunologie, Rheumatologie und Pulmologie Universität Tübingen, Immuntherapie, Station 65 Med. Klinik Abt. II
Tübingen, Germany, 72076
Russian Federation
Non-state health care institution "Central Clinical Hospital No. 2 named after N.A. Semashko OAO "RZHD"
Moscow, Russian Federation, 129128
State Institution "Russian Scientific Oncology Center named after N.N. Blokhin RAMN"
Moscow, Russian Federation, 115478
United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom, HA6 2RN
Sponsors and Collaborators
Mologen AG
Investigators
Principal Investigator: Hans-Joachim Schmoll Klinik für Innere Medizin IV, Universitätsklinikum Halle (Saale)
  More Information

No publications provided

Responsible Party: Mologen AG
ClinicalTrials.gov Identifier: NCT01208194     History of Changes
Other Study ID Numbers: MGN1703-C02, 2009-017432-40
Study First Received: August 27, 2010
Last Updated: June 19, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Federal Office for Safety in Health Care
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Agence Francaise de Securite Sanitaire des Produits de Sante
Russian Federation: Ministry of Healthcare and Social Development of the Russian Federation
Czech Republic: State Institute for Drug Control

Keywords provided by Mologen AG:
Advanced colorectal carcinoma
Maintenance therapy
Immunomodulator

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014