NSCLCPhase 2NCT00874848
Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Imprime PGG Injection, Cetuximab and Paclitaxel in people with NSCLC, run by HiberCell, Inc. at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Imprime PGG Injection, Cetuximab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Aug 2009to Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
- ALT ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases) obtained within 1 week prior to the first dose of study medication;
- If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.
Who cannot join
- 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:
Show all 20Show fewer
- 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
- Has a know sensitivity to Cremophor EL
- Has previously received treatment with cetuximab
- If female, is pregnant or breast-feeding
- Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication)
- Has previously received an organ or progenitor/stem cell transplant.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Germany9 sites
Helios Clinic Emil von Behring
Berlin
Municipal Clinic Frankfurt Hoescht
Frankfurt
Georg-August University Gottingen
Göttingen, 37075
University Clinical Heidelberg
Heidelberg
Clinic Minden
Minden
Techincal University of Munich
Munich
Clinic Nurnberg Nord
Nuremberg
Universitätsklinikum Ulm
Ulm, 89081
HELIOS Klinikum Wuppertal, Medizinische Klinik 1
Wuppertal, 42283
United States5 sites
Medical College of Georgia
Augusta, Georgia, 30912
Mary Crowley Medical Research Center
Dallas, Texas, 75201
Allison Cancer Center
Midland, Texas, 79701
University of Minnesota
Minneapolis, Minnesota, 55455
Providence Medical Group
Terre Haute, Indiana, 47802
About this study
Official title: Efficacy and Safety Study of Imprime PGG® Injection in Combination With Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer
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
- Being tested
- Imprime PGG Injection, Cetuximab, Paclitaxel, Carboplatin
- Keywords
- Imprime PGG, NSCLC, Cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imprime PGG InjectionBiological
4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
CetuximabBiological
Also called Erbitux
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
PaclitaxelDrug
Also called Abraxane, Taxol, Onxol, Nov-Onxol
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
CarboplatinDrug
Also called Paraplatin
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
| Study group | Role | What they receive |
|---|---|---|
| Imprime PGG | Experimental | Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin Receives: Biological: Imprime PGG Injection; Biological: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin |
| Control | Active comparator | Cetuximab + Paclitaxel/Carboplatin Receives: Biological: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.
Measured: 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
The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.
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.
Measured: 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
The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.
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.
Measured: 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
The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date.
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.
Measured: 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
Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator.
If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date.
Measured: From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2012
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiberCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Folker Schneller, MD, Principal investigator, Technical University, Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874848
- Sponsor's protocol ID
- BT-CL-PGG-LCA0822
- Status last verified
- Oct 2016
- First submitted
- 1 Apr 2009
- Last updated
- 29 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28303530
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Imprime PGG® Injection in Combination With Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00874848
- Acronym / sponsor ID
- BT-CL-PGG-LCA0822
- Conditions
- NSCLC
- Keywords
- Imprime PGG, NSCLC, Cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- HiberCell, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 29 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imprime PGG | Experimental | Biological: Imprime PGG Injection, Biological: Cetuximab, Drug: Paclitaxel, Drug: CarboplatinImprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin |
| Control | Active comparator | Biological: Cetuximab, Drug: Paclitaxel, Drug: CarboplatinCetuximab + Paclitaxel/Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imprime PGG Injection4 mg/kg i.v. over 2 hrs, weekly, in three week cycles | Biological | Imprime PGG |
| CetuximabAlso: Erbituxinitial 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 | Biological | Control, Imprime PGG |
| PaclitaxelAlso: Abraxane, Taxol, Onxol, Nov-Onxol200 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 | Drug | Control, Imprime PGG |
| CarboplatinAlso: Paraplatindose 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 | Drug | Control, Imprime PGG |
Primary outcome
Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
Time frame: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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.
5 secondary outcomes
Overall Survival (OS) in Each Study Arm Based on the Safety Population
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28303530Thomas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Folker Schneller, MD principal investigator
Technical University, Munich
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imprime PGG Injection, Cetuximab and Paclitaxel in people with NSCLC, run by HiberCell, Inc. at 14 sites in 2 countries.
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 18 inclusion and 20 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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review (time frame: From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months). 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 NCT00874848, 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 29 Nov 2016.