AdenocarcinomaPhase 2NCT00377936
EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
A Phase 2 study testing Gemcitabine alone and EndoTAG-1 and Gemcitabine in people with Adenocarcinoma and Metastasis, run by MediGene at 3 sites in 3 countries.
Trial summary
The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Metastasis, Pancreas Neoplasms
- What is being tested?
- Gemcitabine alone and EndoTAG-1 and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2005to Oct 2008
- Phase
- Phase 2
- 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
- Inoperable adenocarcinoma of the pancreas
- Histologic or cytologic confirmation
- At least 18 years of age
Who cannot join
- Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
- Major surgery within 4 weeks prior to enrollment
- Major cardiovascular disease
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.
- Conditions
- Adenocarcinoma, Metastasis, Pancreas Neoplasms
- Being tested
- Gemcitabine alone, EndoTAG-1 and Gemcitabine
- Keywords
- Adenocarcinoma of the pancreas, Locally advanced, Metastatic
- Medical subject headings
- Adenocarcinoma, Neoplasm Metastasis, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine aloneDrug
Gemcitabine monotherapy 1000 mg/m2 weekly
EndoTAG-1 and GemcitabineDrug
EndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 and GemcitabineDrug
EndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
EndoTAG-1 and GemcitabineDrug
EndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gemcitabine Receives: Drug: Gemcitabine alone |
| 2 | Experimental | EndoTag-1 + Gemcitabine Receives: Drug: EndoTAG-1 and Gemcitabine |
| 3 | Experimental | EndoTag-1 + Gemcitabine Receives: Drug: EndoTAG-1 and Gemcitabine |
| 4 | Experimental | EndoTag-1 + Gemcitabine Receives: Drug: EndoTAG-1 and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: Median
6-month-survival-rate
Measured: 6 Months
Overall survival
Measured: Median
Secondary outcomes (2)
Incidence and percentage of patients with Adverse Events
Measured: 28 days after last patient out
Number of clinically significant abnormal laboratory values
Measured: Last patient out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startSep 2005
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies 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
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Matthias Löhr, Prof., Principal investigator, Universitätsklinikum Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377936
- Sponsor's protocol ID
- CT4001
- Other IDs
- EudraCT No.: 2005-000666-39
- Status last verified
- Nov 2008
- First submitted
- 18 Sep 2006
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomized, Open Label Phase II Trial to Evaluate Safety and Efficacy of a 1st Line Combination Treatment With Weekly Infusions of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG-1) in Three Dose Levels Compared With Gemcitabine Monotherapy in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT00377936
- Acronym / sponsor ID
- CT4001
- Conditions
- Adenocarcinoma, Metastasis, Pancreas Neoplasms
- Keywords
- Adenocarcinoma of the pancreas, Locally advanced, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- MediGeneIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Sep 2006 (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.
The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Gemcitabine aloneGemcitabine |
| 2 | Experimental | Drug: EndoTAG-1 and GemcitabineEndoTag-1 + Gemcitabine |
| 3 | Experimental | Drug: EndoTAG-1 and GemcitabineEndoTag-1 + Gemcitabine |
| 4 | Experimental | Drug: EndoTAG-1 and GemcitabineEndoTag-1 + Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inoperable adenocarcinoma of the pancreas
- Histologic or cytologic confirmation
- At least 18 years of age
Key exclusion criteria (3 listed)
- Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
- Major surgery within 4 weeks prior to enrollment
- Major cardiovascular disease
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 |
|---|---|---|
| Gemcitabine aloneGemcitabine monotherapy 1000 mg/m2 weekly | Drug | 1 |
| EndoTAG-1 and GemcitabineEndoTAG-1 11 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly | Drug | 2 |
| EndoTAG-1 and GemcitabineEndoTAG-1 22 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly | Drug | 3 |
| EndoTAG-1 and GemcitabineEndoTAG-1 44 mg/m2 twice weekly + Gemcitabine 1000 mg/m2 weekly | Drug | 4 |
Primary outcome
Progression free survival
Time frame: Median
6-month-survival-rate
Time frame: 6 Months
Overall survival
Time frame: Median
2 secondary outcomes
Incidence and percentage of patients with Adverse Events
Time frame: 28 days after last patient out
Number of clinically significant abnormal laboratory values
Time frame: Last patient out
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 14 Nov 2008.
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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.
Matthias Löhr, Prof. principal investigator
Universitätsklinikum Mannheim
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine alone and EndoTAG-1 and Gemcitabine in people with Adenocarcinoma and Metastasis, run by MediGene at 3 sites in 3 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 3 inclusion and 3 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 14 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Hungary, Ukraine. 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?
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?
Progression free survival (time frame: Median). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2008.