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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Colorectal Carcinoma

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Trial Information

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


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.


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

Type of Study:

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

Outcome Measure:

Evaluation of median progression-free survival (PFS) in both treatment groups

Outcome Time Frame:

Measured on accrual time 3 years

Safety Issue:

No

Principal Investigator

Hans-Joachim Schmoll

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinik für Innere Medizin IV, Universitätsklinikum Halle (Saale)

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

MGN1703-C02

NCT ID:

NCT01208194

Start Date:

June 2010

Completion Date:

December 2012

Related Keywords:

  • Advanced Colorectal Carcinoma
  • Advanced colorectal carcinoma
  • Maintenance therapy
  • Immunomodulator
  • Carcinoma
  • Colorectal Neoplasms

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