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

NCT00633529 | Completed Phase 1

• 1 other identifier: EMR 200068-200
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Phase 1b; Non-Small Cell Lung Cancer; Advanced or Metastatic Disease; Prior chemotherapy

Outcome Measures

Primary Outcomes (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).

  Assessed on a weekly basis at patient visits.

Secondary Outcomes (3)

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

  Assessed on a weekly basis at patient visits.

• 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.

  Assessed on a weekly basis at patient visits.

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

  Assessed every six weeks.

Study Arms (1)

I

EXPERIMENTAL

Single arm: triple combination

Drug: IMO-2055

Interventions

IMO-2055 DRUG

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.

I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (9)

Cancer Centers of Florida

Ocoee, Florida, 34761, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

New York Oncology Hematology P.C.

Albany, New York, 12206, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Northwest Cancer Specialists

Vancouver, Washington, 98684, United States

Location

Yakima Valley Memorial Hospital/North Shore Cancer Lodge

Yakima, Washington, 98902, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

IMO-2055

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Phil Breitfeld, MD

  EMD Serono

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 12, 2008
• Study Start: November 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2011
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

US (9)