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Non-Small Cell Lung CancerPhase 1NCT00633529

Safety of Adding IMO-2055 to Erlotinib + Bevacizumab in 2nd Line Treatment for Patients With NSCLC

A Phase 1 study testing IMO-2055 in people with Non-Small Cell Lung Cancer, run by EMD Serono at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety of the proposed Phase II dosage of the investigational drug IMO 2055 when combined with erlotinib and bevacizumab in patients with previously treated advanced NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
IMO-2055
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
9 sitesUnited States
Study dates
Nov 2007to Mar 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
  • AJCC stage 3 or 4 histologically proven NSCLC not amenable to curative therapy and for whom erlotinib and bevacizumab therapy would be appropriate
  • Radiological assessment within 21 days prior to inclusion, if measurable disease is present
  • Age ≥ 18 years
  • ECOG performance status 0 or 1
  • Patient has received at least one standard platinum-containing chemotherapy regimen appropriate for his/her lung cancer, in the opinion of the investigator, prior to enrollment.

Who cannot join

  • Patients with any of the following will be excluded from participation in the study:
  • Disease
  • Squamous cell carcinoma, except for patients with no intrathoracic disease or small peripheral lesions only.
  • Known central nervous system (CNS) metastases (Note: patients with brain metastases which have been controlled for ≥ 4 months without the use of steroid are eligible).
  • Prior Treatments
  • Less than 4 weeks between registration and the last receipt of chemotherapy, biotherapy, radiotherapy or major surgery
Show all 40Show fewer
  • Concurrent or planned hormonal agents such as replacement therapy, oral contraceptives, or anti-cancer therapy, e.g. Megace. (A prior history of such therapy is not exclusionary.)
  • Administration of any investigational agent (therapeutic or diagnostic), including any investigational compound for the treatment of NSCLC, within 4 weeks prior to first study dosing Other Concomitant Medications
  • High dose oral or intravenous corticosteroids. (Note: topical, inhaled and intra-articular corticosteroids are allowed. Prophylactic antihistamines are allowed before administration of bevacizumab
  • Use of any medication which is a strong inhibitor or inducer of cytochrome P450 isoform CYP3A4 (see Appendix 5)
  • Therapeutic dosing with warfarin >1 mg/day
  • Chronic daily use of aspirin (> 325 mg/day) or other full-dose NSAIDs with anti-platelet activity
  • Inability to take oral medication or requirement for IV alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption Laboratory
  • The following laboratory results, within 10 days of first study drug administration:
  • Hemoglobin ≤ 9.0 g/dL Absolute neutrophil count ≤ 1.5 x 109/L Platelet count ≤ 100 x 109/L
  • International Normalized Ratio (INR) > 1.3 (only if the subject is on warfarin [< 1 mg per day]) during 28 days prior to enrollment.
  • aPTT > Upper Limit of Normal (ULN) during 28 days prior to enrollment.
  • Serum creatinine ≥ 1.5 x ULN and creatinine clearance (by Cockcroft-Gault formula) <60 mL/min
  • Serum bilirubin ≥ 1.5 x ULN
  • Proteinuria: UPC ≥ 1.0 or ≥ 2+ proteinuria by urine dipstick, unless a 24-hour urine demonstrates <1.0 g/24 hours
  • ALT or AST ≥ 2.5 x ULN (≥ 5 x ULN if liver metastases)
  • Alkaline phosphatase ≥ 2.5 x ULN
  • Albumin ≤ 2.5 g/L
  • Women of child bearing potential: positive pregnancy test (serum). Other Conditions or Procedures
  • Any clinically significant adverse events from any prior chemotherapy, surgery or radiotherapy which has not yet resolved to CTCAE v3.0 grade ≤ 1
  • Known hypersensitivity to any oligodeoxynucleotide (ODN), EGFR-inhibitor or bevacizumab
  • Serious, non-healing wound, ulcer or bone fracture
  • Patients with a history or current neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix and except for other cancers treated for cure and with a disease-free survival greater than 5 years.
  • Pregnant or breast-feeding women
  • Men or women of childbearing potential who refuse or who are unable to use an acceptable means of contraception
  • History of clinically significant hemoptysis within 3 months prior to registration unless definitively treated with surgery or radiation
  • Any medical conditions that would impose excessive risk to the patient, such as uncontrolled hypertension (systolic >150 mmHg or diastolic >100 mmHg per JNC 7 guidelines, congestive heart failure NYHA Class 2-4, uncontrolled or unstable angina, myocardial infarction within the previous 6 months, ventricular arrhythmia, infection requiring parental or oral anti-infective treatment, any altered mental status or any psychiatric condition that would interfere with understanding the informed consent, uncontrolled seizures, chronic hepatitis or cirrhosis, known human immunodeficiency virus (HIV) infection, known hepatitis B surface antigen (HBsAg) positive or uncontrolled diabetes. (Note: testing for HIV infection of HBsAg is not part of the screening assessments performed by the central laboratory).
  • Pre-existing autoimmune or antibody-mediated diseases, including, but not limited to, the following: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome and autoimmune thrombocytopenia
  • Evidence of bleeding diathesis or coagulopathy or other serious or acute internal bleeding within 6 months prior to registration
  • CNS bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
  • History of allogeneic organ transplant
  • Brain biopsy within 12 weeks of first study dosing
  • Minor surgical procedure, central venous catheter placement, fine needle aspirations or core biopsy within 7 days prior to first study dosing
  • Anticipation of need for a major surgical procedure during the course of the study Other
  • Unwilling or unable to comply with the protocol for the duration of the study

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • New York Oncology Hematology P.C.

    Albany, New York, 12206

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75246

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Cancer Centers of Florida

    Ocoee, Florida, 34761

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684

  • Yakima Valley Memorial Hospital/North Shore Cancer Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Open-Label Phase 1b Study of Erlotinib Plus Bevacizumab and IMO-2055 in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Chemotherapy for Advanced or Metastatic Disease

To evaluate the safety of the proposed Phase II dosage of the investigational drug IMO 2055 when combined with erlotinib and bevacizumab in patients with previously treated advanced NSCLC.

Read the detailed description

Phase 1b study of escalating doses of weekly subcutaneous IMO-2055 combined with fixed standard dose regimens of oral erlotinib (daily) and IV bevacizumab (every 3 weeks) in patients with previously treated advanced NSCLC.

Being tested
IMO-2055
Keywords
Phase 1b, Non-Small Cell Lung Cancer, Advanced or Metastatic Disease, Prior chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

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

  • IMO-2055Drug

    0.08, 0.16, or 0.32 mg/kg SC (subcutaneous) on days 1,8,and 15 of every 21 day cycle until evidence of progressive disease, unacceptable treatment-related toxicities, withdrawal of patient consent and/or Investigator decision to withdraw study therapy with documented reason, whichever occurs first.

Study groups in NCT00633529
Study groupRoleWhat they receive
IExperimentalSingle arm: triple combination
Receives: Drug: IMO-2055

What is being measured

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

  1. To determine the recommended dosage of IMO-2055 when combined with erlotinib and bevacizumab in patients with AJCC stage 3 or 4 histologically proven non-small cell lung cancer (NSCLC).

    Measured: Assessed on a weekly basis at patient visits.

Secondary outcomes (3)

  1. To evaluate the safety of weekly IMO-2055 combined with erlotinib plus bevacizumab using NCI CTCAE version 3.

    Measured: Assessed on a weekly basis at patient visits.

  2. To investigate potential drug-drug interactions via a PK study, specifically the effect of IMO-2055 on the PK of bevacizumab and the PK of erlotinib and also the effect of bevacizumab and erlotinib on the PK of IMO-2055.

    Measured: Assessed on a weekly basis at patient visits.

  3. To investigate potential signs of efficacy using RECIST response rate in measurable patients and PFS in all patients.

    Measured: Assessed every six weeks.

Timeline

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

  1. First posted12 Mar 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionOct 2010
  4. Study completionMar 2011

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00633529
Sponsor's protocol ID
EMR 200068-200
Status last verified
Oct 2013
First submitted
3 Mar 2008
Last updated
22 Oct 2013
Results posted
No
Data monitoring committee
No

Publications

  • Smith, D., P. Conkling, D. Richards, C. Alemany, T. Boyd, L. Garbo, D. Loesch, D. Wages, A. Bexon, J. Murphy. Phase 1 Study of the Toll-like Receptor (TLR9) Agonist, IMO-2055, Combined with Erlotinib and Bevacizumab in Patients with Advanced or Metastatic non-Small Cell Lung Cancer. ECCO-ESMO Annual Meeting, 2009. Abstract 9.148.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMO-2055 in people with Non-Small Cell Lung Cancer, run by EMD Serono at 9 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 7 inclusion and 40 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: finished, 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 9 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the recommended dosage of IMO-2055 when combined with erlotinib and bevacizumab in patients with AJCC stage 3 or 4 histologically proven non-small cell lung cancer (NSCLC). (time frame: Assessed on a weekly basis at patient visits.). 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 NCT00633529, 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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