Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer

NCT00874848 | Completed Phase 2 Results DMC

• 1 other identifier: BT-CL-PGG-LCA0822
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 14

Brief Summary

The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.

Conditions

NSCLC

Keywords

Imprime PGG; NSCLC; Cetuximab

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review

  Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines.

  From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

Secondary Outcomes (5)

• Overall Survival (OS) in Each Study Arm Based on the Safety Population

  From the time of randomization to death, subject being lost to follow-up or study completion

• Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review

  From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

• Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review

  From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

• Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review

  From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months

• Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review

  From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months

Study Arms (2)

Imprime PGG

EXPERIMENTAL

Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin

Biological: Imprime PGG Injection; Biological: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin

Control

ACTIVE COMPARATOR

Cetuximab + Paclitaxel/Carboplatin

Biological: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Imprime PGG Injection BIOLOGICAL

4 mg/kg i.v. over 2 hrs, weekly, in three week cycles

Imprime PGG

Cetuximab BIOLOGICAL

initial loading dose of 400 mg/m\^2 over 120 min and subsequent doses at 250 mg/m\^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle

Also known as: Erbitux

Control; Imprime PGG

Paclitaxel DRUG

200 mg/m\^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles

Also known as: Abraxane, Taxol, Onxol, Nov-Onxol

Control; Imprime PGG

Carboplatin DRUG

dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles

Also known as: Paraplatin

Control; Imprime PGG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
• Is between the ages of 18 and 75 years old, inclusive
• Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
• Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
• Has an ECOG performance status of 0 or 1
• Has a life expectancy of \> 3 months
• Has adequate hematologic function as evidenced by:
• ANC ≥ 1,500/μL
• PLT ≥ 100,000/μL
• HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;
• Has adequate renal function as evidenced by:
• Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
• Urine dipstick for proteinuria of \< 1+ (i.e., either 0 or trace) within 2 weeks of Day 1 If urine dipstick is ≥ 1+, then urine protein excretion must be ≤ 500 mg over a 24 hour collection obtained within 1 week prior to the first dose of study medication;
• Has adequate hepatic function as evidenced by:
• Serum total bilirubin ≤ 1.0 mg/dL

You may not qualify if:

• Has received prior systemic chemotherapy at any time for lung cancer;
• Has received previous radiation therapy to \>30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
• Has a known hypersensitivity to baker's yeast, or has an active yeast infection
• Has had previous exposure to Betafectin® or Imprime PGG
• Has an active infection
• Presents with any of the following medical diagnoses/conditions at the time of screening:
• Central nervous system (CNS) metastases
• Uncontrolled hypertension (\>150/100 mmHg) or hypertension that requires \> two agents for adequate control
• Peripheral neuropathy ≥ grade 2 from any cause
• Fever of \>38.5° C within 3 days prior to screening or Day 1, initial dosing
• Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician's opinion could interfere with participation
• Has a history of any of the following medical diagnoses/conditions:
• Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
• Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of \<2.0 ng/mL
• Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab

Sponsors & Collaborators

• HiberCell, Inc.: lead

Study Sites (14)

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

Allison Cancer Center

Midland, Texas, 79701, United States

Location

Helios Clinic Emil von Behring

Berlin, Germany

Location

Municipal Clinic Frankfurt Hoescht

Frankfurt, Germany

Location

Georg-August University Gottingen

Göttingen, 37075, Germany

Location

University Clinical Heidelberg

Heidelberg, Germany

Location

Clinic Minden

Minden, Germany

Location

Techincal University of Munich

Munich, Germany

Location

Clinic Nurnberg Nord

Nuremberg, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

HELIOS Klinikum Wuppertal, Medizinische Klinik 1

Wuppertal, 42283, Germany

Location

Related Publications (1)

• Thomas M, Sadjadian P, Kollmeier J, Lowe J, Mattson P, Trout JR, Gargano M, Patchen ML, Walsh R, Beliveau M, Marier JF, Bose N, Gorden K, Schneller F 3rd. A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3-1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer. Invest New Drugs. 2017 Jun;35(3):345-358. doi: 10.1007/s10637-017-0450-3. Epub 2017 Mar 16.

  PMID: 28303530 DERIVED

MeSH Terms

Interventions

Cetuximab; Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Coordination Complexes

Results Point of Contact

• Title: Jamie Lowe, Vice President, Clinical Development
• Organization: Biothera

jlowe@biothera.com

651-256-4653

Study Officials

• Folker Schneller, MD

  Technical University, Munich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 3, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: August 1, 2015
• Last Updated: November 29, 2016
• Results First Posted: November 29, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); DE (9)