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Colorectal CancerPhase 1NCT00719199

Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer

A Phase 1 study testing IMO-2055, Cetuximab and FOLFIRI in people with Colorectal Cancer, run by EMD Serono at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Open-label phase 1b trial. Study treatment will be administered in 3 week cycles. There are two distinct parts in this study: Part 1: Dose escalation from IMO-2055 Part 2: Once a recommended phase 2 dose is found additional tolerability and pharmacodynamics will be explored Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
IMO-2055, Cetuximab and FOLFIRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
5 sitesUnited States
Study dates
Jan 2009to Aug 2011
Phase
Phase 1
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must satisfy all the following inclusion criteria in order to be eligible for the study:
  • Signed written informed consent prior to any study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
  • Male or female patients aged ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically confirmed adenocarcinoma of the colon or rectum with advanced or metastatic disease.
  • Patients whose disease has recurred or progressed during or after completion of at least one (1) standard regimen of cytotoxic agents. Patients may have had any number of prior regimens as long as the other entry criteria are met. Preferred patients are those who have progressed on first line FOLFIRI or FOLFOX with or without bevacizumab. Patients may have had prior exposure to monoclonal antibodies such as cetuximab, bevacizumab or panitumumab.
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  • All clinically significant adverse events of any prior chemotherapy, surgery or radiotherapy must have resolved to CTCAE v3.0 grade ≤ 1. Neuropathy of CTCAE v3.0 grade ≤ 2 will be allowed but the neuropathy should be closely monitored throughout the trial.
  • A minimum of 4 weeks must occur between last receipt of chemotherapy, biotherapy, radiotherapy, or major surgery and registration.
  • Be willing and able to comply with the protocol for the duration of the study.
  • If prior malignancy was diagnosed, other than colorectal, no evidence of disease from that cancer, off all therapy for that cancer and recovered to grade 1 or less toxicity from prior treatment.

Who cannot join

  • Patients with any of the following will be excluded from participation in the study:
  • Disease
  • Known central nervous system (CNS) metastases unless controlled for ≥ 4 months without the use of steroids.
  • Patients who are candidates for neoadjuvant "conversion" therapy followed by curative surgery.
  • Prior Treatments
  • Prior pelvic irradiation.
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  • Administration of any investigational agent (therapeutic or diagnostic), within 4 weeks prior to first study dosing.
  • Patients with a prior history of cetuximab hypersensitivity may be admitted to Part 1 of the study only.
  • Other Concomitant Medications
  • Chronic oral or intravenous corticosteroids. (Note: Doses ≤ 5 mg/day of prednisone or equivalent are permitted. Topical, inhaled and intra-articular corticosteroids are allowed.)
  • Therapeutic anticoagulation (warfarin > 1 mg/day or heparin). Low-dose warfarin for port prophylaxis and low-molecular weight heparin at therapeutic doses are allowed.
  • Laboratory
  • The following laboratory results:
  • Hemoglobin < 9.0 g/dL Absolute neutrophil count < 1.5 x 109/L Platelet count < 100 x 109/L
  • Total bilirubin > 1.5 x upper limit of normal (ULN)
  • ALT or AST > 2.5 x ULN (> 5 x ULN if liver metastases present)
  • Alkaline phosphatase > 2.5 x ULN (> 5 x ULN if liver metastases present, or > 10 x ULN in case of the presence of bone metastases)
  • Serum creatinine > 1.5 x ULN
  • Albumin < 2.5 g/dL Other Conditions or Procedures
  • Grade 3 or 4 non-hematological toxicity or febrile neutropenia related to previous irinotecan-based regimens.
  • Homozygous for the UGT1A1*28 allele.
  • Known hypersensitivity to murine proteins or oligonucleotides.
  • Pregnant or breast-feeding women.
  • Women of childbearing potential with either positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Men or women of childbearing potential who refuse or who are unable to use an acceptable means of contraception during the study.
  • History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance.
  • Pre existing autoimmune or antibody-mediated diseases, including, but not limited to, the following: organ allografts, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome and autoimmune thrombocytopenia, known Gilbert's syndrome.
  • Signs/symptoms of bowel obstruction or pseudo-obstruction or history of inflammatory bowel disease.
  • Clinically significant (i.e., active) cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
  • Interstitial pneumonia or extensive symptomatic fibrosis of the lungs.
  • Serious uncontrolled concomitant disease, intercurrent infections, or other known medical conditions that in the opinion of the Investigator puts the patient at increased risk for significant toxicities from treatment, such as hypertension, uncontrolled by medication, chronic hepatitis (viral or other) or cirrhosis, known human immunodeficiency virus (HIV) infection, or uncontrolled diabetes.
  • Legal incapacity or limited legal capacity.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Cancer Therapy & Research Center

    San Antonio, Texas, 78229

  • Cancer Therapy and Research Center

    San Antonio, Texas

  • Georgetown University Lombardi Cancer Center

    Washington D.C., District of Columbia

Other trials in United States

About this study

Official title: Open-label Phase 1b Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer Who Have Progressed Following Chemotherapy for Advanced or Metastatic Disease

Open-label phase 1b trial. Study treatment will be administered in 3 week cycles.

There are two distinct parts in this study:

  • Part 1: Dose escalation from IMO-2055
  • Part 2: Once a recommended phase 2 dose is found additional tolerability and pharmacodynamics will be explored
Read the detailed description
  • Part 1: Dose escalation of IMO-2055, including 3 dose groups. Once a recommended phase 2 dosage (RP2D) of IMO-2055 given concomitantly with FOLFIRI and cetuximab is found the selected cohort will be expanded by an additional 6 to 9 patients (to a total of 12 patients) for confirmation of the RP2D and combination treatment regimen.
  • Part 2: A final cohort of 12 patients (Cohort 6) will be enrolled simultaneously to explore tolerability and pharmacodynamics in patients treated with the RP2D of IMO-2055 in combination with FOLFIRI with cetuximab.
Being tested
IMO-2055, Cetuximab, FOLFIRI
Keywords
Colorectal cancer, metastatic cancer, prior therapy, 1b
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMO-2055Drug

    SC weekly injections

  • CetuximabDrug

    given weekly through intravenous administration. Cycle 1 Day 1 dose given at 400mg/m2, all subsequent doses given at 250 mg/m2.

  • FOLFIRIDrug

    Given day 1 of each cycle

Study groups in NCT00719199
Study groupRoleWhat they receive
1ExperimentalIMO 2055 is a novel phosphorothioate oligodeoxynucleotide that is an agonist of Toll-like Receptor 9 (TLR9).
Receives: Drug: IMO-2055; Drug: Cetuximab; Drug: FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • The primary objective of this study is to determine the recommended phase 2 dose of IMO 2055 when combined with FOLFIRI and cetuximab in patients with histologically proven advanced or metastatic colorectal cancer (CRC).

    Measured: 10 months from first patient in, Oct 2010

Secondary outcomes (7)

  1. • To evaluate the safety of weekly IMO 2055 combined with FOLFIRI plus cetuximab.

    Measured: Assessed weekly at patient visits

  2. • To investigate the pharmacokinetics (PK) of IMO-2055.

    Measured: Assessed weekly at patient visits until Cycle 4

  3. • To investigate the tolerability and pharmacodynamic (PD) effects of dexamethasone scheduling with IMO 2055 and FOLFIRI.

    Measured: Assessed weekly at patient visits until Cycle 4

  4. • To investigate potential signs of efficacy using the Response Evaluation Criteria for Solid Tumors (RECIST) response rate in patients with measurable disease.

    Measured: Every six weeks

  5. • To investigate progression-free survival (PFS) and overall survival for up to one year in all patients.

    Measured: Every three months

  6. • To investigate results of subsequent therapy (if any) in all patients.

    Measured: Every three months

  7. • To investigate potential markers of IMO 2055 immune activation and effect on cellular immunity.

    Measured: Assessed weekly at patient visits until Cycle 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionApr 2011
  4. Study completionAug 2011

Why it stopped: Sponsor will discontinue further development of EMD 1201081

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00719199
Sponsor's protocol ID
IMO-2055-210
Other IDs
EMR200068_210
Status last verified
Oct 2013
First submitted
17 Jul 2008
Last updated
22 Oct 2013
Results posted
No
Data monitoring committee
No

Publications

  • Chan E, Kwak EL, Hwang J, Heiskala M, de La Bourdonnaye G, Mita M. Open-label phase 1b study of FOLFIRI plus cetuximab plus IMO-2055 in patients with colorectal cancer who have progressed following chemotherapy for advanced or metastatic disease. Cancer Chemother Pharmacol. 2015 Apr;75(4):701-9. doi: 10.1007/s00280-015-2682-2. Epub 2015 Jan 28.

    PubMed 25627002

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMO-2055, Cetuximab and FOLFIRI in people with Colorectal Cancer, run by EMD Serono at 5 sites in United States.

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 10 inclusion and 32 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: stopped early, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 stopped early (reason given: Sponsor will discontinue further development of EMD 1201081). Results are not available in the source record.

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.

What does the primary outcome measure?

• The primary objective of this study is to determine the recommended phase 2 dose of IMO 2055 when combined with FOLFIRI and cetuximab in patients with histologically proven advanced or metastatic colorectal cancer (CRC). (time frame: 10 months from first patient in, Oct 2010). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00719199, which also lists 1 linked publication.

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 22 Oct 2013.

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