Pancreatic NeoplasmsPhase 1NCT02215044
Dose-finding Study of BI 2536 Administered in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase 1 study testing BI 2536, intravenous and Gemcitabine, intravenous in people with Pancreatic Neoplasms, run by Boehringer Ingelheim.
Trial summary
Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15 every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and characterisation the antitumor activity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- BI 2536, intravenous and Gemcitabine, intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Dec 2008
- Phase
- Phase 1
- 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
- Patient with histologically or cytologically confirmed locally advanced, unresectable or metastasized adenocarcinoma of the pancreas who:
- have not received gemcitabine chemotherapy for locally advanced or metastatic pancreatic cancer or
- have progressive disease not before at least 6 months from cessation of adjuvant gemcitabine chemotherapy following curative surgical tumor resection
- Male or female patient aged 18 years or older
- Life expectancy of at least three (3) months
- Eastern Co-operative Oncology Group (ECOG) performance score of 2 or less
- Patient must have given written informed consent
Who cannot join
- Prior chemo- (other than adjuvant gemcitabine), hormone- (other than Megace®) or immunotherapy
- Ampullary carcinoma of the pancreas
- Brain metastases, which are symptomatic or require therapy
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
- Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer)
- Absolute neutrophil count (ANC) <1,500/μl, platelet count <150,000/μl, or hemoglobin <9 g/dl
Show all 19Show fewer
- Total bilirubin >1.8mg/dl (>30.78 μmol/l,, international system of units (SI) equivalent) under adequate drainage measures (in case of obstructive jaundice)
- No hepatic metastases: Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 x upper limit of normal (ULN). Hepatic metastases: aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >5 x ULN
- Serum creatinine >2.0 mg/dl (>176 μmol/L, SI Unit equivalent)
- Radiotherapy within the last 2 weeks prior to or during treatment with the trial drug
- Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents)
- Patients with known HIV, Hepatitis-B or -C infection
- Known or suspected active drug or alcohol abuse
- Women of child-bearing potential; men who are able to father a child and are unwilling to use a medically acceptable method of contraception during the trial
- Pregnancy or breast feeding
- Treatment with any investigational drug within the past 4 weeks or within less than four half-life times of the investigational drug before treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant
- Patient unable to comply with the protocol
- Patients requiring warfarin (Coumadin®) or patients with a known pre-existing coagulopathy unrelated to pancreatic cancer (This means, for example, that patient with a long (years) history or recurrent venocclusive disease clearly preceding the diagnosis of pancreatic cancer will be excluded from the study. Patients with recent hypercoagulable state (ie deep vein thrombosis or pulmonary embolism) due to pancreatic cancer who are clinically stable on low molecular weight heparin will not be excluded)
- Patients with neuropathy (sensory or motor) ≥ common terminology criteria for adverse events (CTCAE) 3
About this study
Official title: A Phase I Open-label Dose-finding Study of Intravenous BI 2536 Administered in Repeated 4-week Cycles as Repeated Doses on Day 1 and Day 15 in Combination With Gemcitabine Administered on Day 1, Day 8 and Day 15 in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15 every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and characterisation the antitumor activity, pharmacokinetic (PK) profile, and CA 19-9 tumor marker response in response to the combination of BI 2536 with gemcitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma.
- Conditions
- Pancreatic Neoplasms
- Being tested
- BI 2536, intravenous, Gemcitabine, intravenous
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 2536, intravenousDrug
Gemcitabine, intravenousDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 2536 in combination with gemcitabine | Experimental | Not described Receives: Drug: BI 2536, intravenous; Drug: Gemcitabine, intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of dose limiting toxicity according to CTCAE
Measured: up to day 28 of each cycle
Secondary outcomes (5)
Area under the concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
Measured: Pre-dose, up to 192 hours after start of treatment
Maximum measured concentration of the analytes in plasma (Cmax)
Measured: Pre-dose, up to 192 hours after start of treatment
Objective tumour responses based on Response evaluation criteria in solid tumors (RECIST) criteria
Measured: up to 1 year
Survival status
Measured: up to 1 year
Tumor marker (CA19-9) response to treatment with BI 2536 and gemcitabine
Measured: Day 1 of each treatment cycle prior to administration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJun 2007
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215044
- Sponsor's protocol ID
- 1216.8
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label Dose-finding Study of Intravenous BI 2536 Administered in Repeated 4-week Cycles as Repeated Doses on Day 1 and Day 15 in Combination With Gemcitabine Administered on Day 1, Day 8 and Day 15 in Patients With Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02215044
- Acronym / sponsor ID
- 1216.8
- Conditions
- Pancreatic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (actual)
- First posted
- 13 Aug 2014 (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.
Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15 every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and characterisation the antitumor activity, pharmacokinetic (PK) profile, and CA 19-9 tumor marker response in response to the combination of BI 2536 with gemcitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 2536 in combination with gemcitabine | Experimental | Drug: BI 2536, intravenous, Drug: Gemcitabine, intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with histologically or cytologically confirmed locally advanced, unresectable or metastasized adenocarcinoma of the pancreas who:
- Male or female patient aged 18 years or older
- Life expectancy of at least three (3) months
- Eastern Co-operative Oncology Group (ECOG) performance score of 2 or less
- Patient must have given written informed consent
Key exclusion criteria (19 listed)
- Prior chemo- (other than adjuvant gemcitabine), hormone- (other than Megace®) or immunotherapy
- Ampullary carcinoma of the pancreas
- Brain metastases, which are symptomatic or require therapy
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
- Other malignancies diagnosed within the past five (5) years (other than non-melanomatous 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 |
|---|---|---|
| BI 2536, intravenous | Drug | BI 2536 in combination with gemcitabine |
| Gemcitabine, intravenous | Drug | BI 2536 in combination with gemcitabine |
Primary outcome
Occurence of dose limiting toxicity according to CTCAE
Time frame: up to day 28 of each cycle
5 secondary outcomes
Area under the concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
Time frame: Pre-dose, up to 192 hours after start of treatment
Maximum measured concentration of the analytes in plasma (Cmax)
Time frame: Pre-dose, up to 192 hours after start of treatment
Objective tumour responses based on Response evaluation criteria in solid tumors (RECIST) criteria
Time frame: up to 1 year
Survival status
Time frame: up to 1 year
Tumor marker (CA19-9) response to treatment with BI 2536 and gemcitabine
Time frame: Day 1 of each treatment cycle prior to administration of study treatment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 2536, intravenous and Gemcitabine, intravenous in people with Pancreatic Neoplasms, run by Boehringer Ingelheim.
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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Occurence of dose limiting toxicity according to CTCAE (time frame: up to day 28 of each cycle). 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 13 Aug 2014.