Pancreatic Cancer, Advanced or MetastaticPhase 2/3NCT00561990
Nimotuzumab in Adults With Pancreatic Cancer
A Phase 2/3 study testing Nimotuzumab in people with Pancreatic Cancer, Advanced or Metastatic, run by Oncoscience AG at 1 site in Germany.
Trial summary
CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer, Advanced or Metastatic
- What is being tested?
- Nimotuzumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Jan 2014
- Phase
- Phase 2/3
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- written informed consent.
- histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
- measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (ie, target lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography [CT] scan).
- able to take medications orally.
- at least18 years of age or older.
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- Karnofsky Performance Status (KPS) ≥ 70% (see Appendix A).
- life expectancy of > 12 weeks.
- adequate organ function as defined by the following criteria:
- Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal (ULN).
- If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN.
- Total serum bilirubin ≤ 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be ≤ 5 times ULN).
- Absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units (IU]).
- Platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L).
- Hemoglobin value ≥ 9.0 g/dL.
- Calculated creatinine clearance ≥ 60 mL/min (based on serum creatinine) (Cockcroft Gault formula).
- willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- both female and male patients must use adequate methods of contraception.
Who cannot join
- had treatment with any of the following within the specified time frame prior to study drug administration:
- Any prior anticancer chemotherapy.
- Radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease).
- Any radiotherapy within the previous 3 weeks.
- Any investigational agent received either concurrently or within the last 30 days.
- Current enrollment in another clinical trial.
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- Major surgery within the previous 3 weeks.
- Symptomatic brain metastasis not controlled by corticosteroids.
- Leptomeningeal metastasis.
- Previous or concurrent malignancy other than pancreatic cancer except adequately treated carcinoma in-situ of the cervix or non-melanoma skin cancer.
- Uncontrolled ascites requiring drainage at least twice a week.
- Other serious illness or medical condition(s) including, but not limited to, the following:
- Uncontrolled congestive heart failure (New York Heart Association [NYHA]
- Class III or IV, see Appendix F), angina pectoris, arrhythmias, or hypertension.
- active infection.
- known (at time of entry) gastrointestinal disorder, including malabsorption,
- chronic nausea, vomiting, or diarrhea, present to the extent that it might interfere with oral intake and absorption of study medication.
- Poorly controlled diabetes mellitus.
- Psychiatric disorder that may interfere with consent and/or protocol compliance.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study.
- pregnant or lactating female.
- known hypersensitivity to Anti-EGFR antibodies.
- with reproductive potential who refuses to use an adequate means of contraception (including male patients).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RANDOMIZED, MULTICENTER, PHASE IIB/IIIA STUDY OF GEMCITABINE AND THE MONOCLONAL ANTIBODY NIMOTUZUMAB (OSAG 101) VERSUS GEMCITABINE AND PLACEBO FOR THE TREATMENT OF CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER
CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER
Read the detailed description
Pancreatic cancer is responsible for 227.000 deaths per year, and is the eighth most common cause of death from cancer in both sexes combined, a position relatively high when compared to incidence (thirteenth position) because of the very poor prognosis (the M/I ratio is 98%) (Global Cancer Statistics, 2002). The incidence of pancreatic carcinoma has increased almost 300% since 1950 and now exceeds the incidence of stomach cancer and cancer of the rectum. Carcinoma of the exocrine pancreas is nearly always a fatal disease. The overall 5-year survival rate for the disease is 4.1%.
Locally advanced or metastatic pancreatic cancer is relatively unresponsive to chemotherapy. Gemcitabine therapy provides some benefit and modestly improves survival compared with fluorouracil, but median survival in patients with advanced disease remains less than 6 months (Burris et al, 1997). Cytotoxic drug combinations were not able to show survival advantage compared to Gemcitabine alone in numerous randomized phase III studies.
Altered expression or constitutive activation of the epidermal growth factor receptor (EGFR/HER1/erbB1) commonly occurs in both primary and metastatic pancreatic cancers and is often a critical factor in progressive growth and resistance to normal mechanisms of cell death. Epidermal growth factor receptor expression in pancreatic cancer has been correlated with tumor aggressiveness.
Clinical trials already suggest that EGF-R targeted therapy may improve the antitumor activity of chemotherapy for treatment of pancreatic carcinoma. Monoclonal antibodies specific to EGF-R can be combined safely and effectively with chemotherapy.
Nimotuzumab (OSAG101, hR3, Theraloc) is a humanized monoclonal antibody (mAb) that binds to the EGFR. In preclinical studies the antibody has shown potent antitumor activity. Based on phase I data, the recommended dose has been established at 200 mg weekly. A previous phase II study in children with high grade brain tumors showed activity of Nimotuzumab as a monotherapeutic agent, even in prognostic very unfavourable diffuse, intrinsic pontine glioma. No drug related side effects were reported.
Nimotuzumab (OSAG101, Theraloc) in combination with radiotherapy for treatment of locally advanced squamous cell carcinomas of the head and neck resulted in high rates of antitumor response, and was accompanied by a favourable safety profile. Nimotuzumab (OSAG101, Theraloc) has a high hepatic uptake level.
This randomized, placebo-controlled Phase IIb/IIIa study analyzes the efficacy and safety of Nimotuzumab in combination with Gemcitabine for the treatment of chemotherapy-naive patients with advanced unresectable or metastatic pancreatic carcinoma.
- Being tested
- Nimotuzumab
- Keywords
- pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab | Active comparator | Nimotuzumab Receives: Drug: Nimotuzumab |
| Placebo | Placebo comparator | Placebo Receives: Drug: Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tumor progression (TTP) and overall survival (OS) in chemotherapy-naive patients. To assess the efficacy of Nimotuzumab as add on therapy to Gemcitabine in comparison with Gemcitabine and placebo
Measured: Week 8, 12
Secondary outcomes (1)
To evaluate the objective tumor response (overall response rate [ORR]) and duration of response (DR) To evaluate the safety profile of Nimotuzumab in combination with Gemcitabine To evaluate quality of life (QoL) according to EORTC
Measured: Week 8, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer, Advanced or MetastaticStudies 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 2/3
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncoscience AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Marienhospital Herne, University of Kiel, Gemeinschaftspraxis für Hämatologie und Onkologie, Köln, Germany, Onkologisches Zentrum III, Medizinische Klinik, Mannheim, Germany, Onkologische Gemeinschaftspraxis, Mülheim, Germany, II. Medizinische Klinik u. Poliklinik, Klinikum rechts der Isar, München, Germany, Hämatologisch-Onkologische Schwerpunktpraxis, Münster, Germany, Praxis für Internistische Onkologie und Hämatologie, Recklinghausen, Germany
- Responsible party
- Sponsor
- Investigators
- Dirk Strumberg, MD, Principal investigator, University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561990
- Sponsor's protocol ID
- OSAG101-PCS07
- Status last verified
- Oct 2015
- First submitted
- 20 Nov 2007
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schultheis B, Reuter D, Ebert MP, Siveke J, Kerkhoff A, Berdel WE, Hofheinz R, Behringer DM, Schmidt WE, Goker E, De Dosso S, Kneba M, Yalcin S, Overkamp F, Schlegel F, Dommach M, Rohrberg R, Steinmetz T, Bulitta M, Strumberg D. Gemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb study. Ann Oncol. 2017 Oct 1;28(10):2429-2435. doi: 10.1093/annonc/mdx343.
PubMed 28961832
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, MULTICENTER, PHASE IIB/IIIA STUDY OF GEMCITABINE AND THE MONOCLONAL ANTIBODY NIMOTUZUMAB (OSAG 101) VERSUS GEMCITABINE AND PLACEBO FOR THE TREATMENT OF CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER
- ClinicalTrials.gov ID
- NCT00561990
- Acronym / sponsor ID
- OSAG101-PCS07
- Keywords
- pancreatic cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Oncoscience AGIndustry (pharma, biotech, devices)
- Collaborators
- Marienhospital Herne, University of Kiel, Gemeinschaftspraxis für Hämatologie und Onkologie, Köln, Germany, Onkologisches Zentrum III, Medizinische Klinik, Mannheim, Germany, Onkologische Gemeinschaftspraxis, Mülheim, Germany, II. Medizinische Klinik u. Poliklinik, Klinikum rechts der Isar, München, Germany, Hämatologisch-Onkologische Schwerpunktpraxis, Münster, Germany, Praxis für Internistische Onkologie und Hämatologie, Recklinghausen, Germany
- Study start
- Sep 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CHEMOTHERAPY-NAIVE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC PANCREATIC CANCER
Detailed description
Pancreatic cancer is responsible for 227.000 deaths per year, and is the eighth most common cause of death from cancer in both sexes combined, a position relatively high when compared to incidence (thirteenth position) because of the very poor prognosis (the M/I ratio is 98%) (Global Cancer Statistics, 2002). The incidence of pancreatic carcinoma has increased almost 300% since 1950 and now exceeds the incidence of stomach cancer and cancer of the rectum. Carcinoma of the exocrine pancreas is nearly always a fatal disease. The overall 5-year survival rate for the disease is 4.1%.
Locally advanced or metastatic pancreatic cancer is relatively unresponsive to chemotherapy. Gemcitabine therapy provides some benefit and modestly improves survival compared with fluorouracil, but median survival in patients with advanced disease remains less than 6 months (Burris et al, 1997). Cytotoxic drug combinations were not able to show survival advantage compared to Gemcitabine alone in numerous randomized phase III studies.
Altered expression or constitutive activation of the epidermal growth factor receptor (EGFR/HER1/erbB1) commonly occurs in both primary and metastatic pancreatic cancers and is often a critical factor in progressive growth and resistance to normal mechanisms of cell death. Epidermal growth factor receptor expression in pancreatic cancer has been correlated with tumor aggressiveness.
Clinical trials already suggest that EGF-R targeted therapy may improve the antitumor activity of chemotherapy for treatment of pancreatic carcinoma. Monoclonal antibodies specific to EGF-R can be combined safely and effectively with chemotherapy.
Nimotuzumab (OSAG101, hR3, Theraloc) is a humanized monoclonal antibody (mAb) that binds to the EGFR. In preclinical studies the antibody has shown potent antitumor activity. Based on phase I data, the recommended dose has been established at 200 mg weekly. A previous phase II study in children with high grade brain tumors showed activity of Nimotuzumab as a monotherapeutic agent, even in prognostic very unfavourable diffuse, intrinsic pontine glioma. No drug related side effects were reported.
Nimotuzumab (OSAG101, Theraloc) in combination with radiotherapy for treatment of locally advanced squamous cell carcinomas of the head and neck resulted in high rates of antitumor response, and was accompanied by a favourable safety profile. Nimotuzumab (OSAG101, Theraloc) has a high hepatic uptake level.
This randomized, placebo-controlled Phase IIb/IIIa study analyzes the efficacy and safety of Nimotuzumab in combination with Gemcitabine for the treatment of chemotherapy-naive patients with advanced unresectable or metastatic pancreatic carcinoma.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab | Active comparator | Drug: NimotuzumabNimotuzumab |
| Placebo | Placebo comparator | Drug: NimotuzumabPlacebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- written informed consent.
- histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
- measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (ie, target lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography [CT] scan).
- able to take medications orally.
Key exclusion criteria (24 listed)
- had treatment with any of the following within the specified time frame prior to study drug administration:
- Major surgery within the previous 3 weeks.
- Symptomatic brain metastasis not controlled by corticosteroids.
- Leptomeningeal metastasis.
- Previous or concurrent malignancy other than pancreatic cancer except adequately treated carcinoma in-situ of the cervix or non-melanoma skin cancer.
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 |
|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab, Placebo |
Primary outcome
Time to tumor progression (TTP) and overall survival (OS) in chemotherapy-naive patients. To assess the efficacy of Nimotuzumab as add on therapy to Gemcitabine in comparison with Gemcitabine and placebo
Time frame: Week 8, 12
1 secondary outcome
To evaluate the objective tumor response (overall response rate [ORR]) and duration of response (DR) To evaluate the safety profile of Nimotuzumab in combination with Gemcitabine To evaluate quality of life (QoL) according to EORTC
Time frame: Week 8, 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Derived from this study: PubMed 28961832Schultheis B, Reuter D, Ebert MP, Siveke J, Kerkhoff A, Berdel WE, Hofheinz R, Behringer DM, Schmidt WE, Goker E, De Dosso S, Kneba M, Yalcin S, Overkamp F, Schlegel F, Dommach M, Rohrberg R, Steinmetz T, Bulitta M, Strumberg D. Gemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb study. Ann Oncol. 2017 Oct 1;28(10):2429-2435. doi: 10.1093/annonc/mdx343.
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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.
Dirk Strumberg, MD principal investigator
University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nimotuzumab in people with Pancreatic Cancer, Advanced or Metastatic, run by Oncoscience AG at 1 site in Germany.
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 24 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to tumor progression (TTP) and overall survival (OS) in chemotherapy-naive patients. To assess the efficacy of Nimotuzumab as add on therapy to Gemcitabine in comparison with Gemcitabine and placebo (time frame: Week 8, 12). 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 NCT00561990, 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 15 Oct 2015.