Pancreatic NeoplasmsPhase 1/2BAGPACNCT01251640
Combination With Gemcitabine in Advanced Pancreatic Cancer
A Phase 1/2 study testing BAY86-9766+Gemcitabine in people with Pancreatic Neoplasms, run by Bayer at 23 sites in 9 countries.
Trial summary
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer. Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- BAY86-9766+Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 23 sitesin 9 countries
- Study dates
- 1 Jan 2011to 1 Aug 2013
- Phase
- Phase 1/2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥18 years of age
- Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery
- Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1
- Resolution of all acute toxic effects of any prior local treatment to Common Terminology Criteria for Adverse Events (CTCAE) Grade </= 1
- Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2
- Patient has cardiac function, within normal range, as measured by an echocardiogram
Who cannot join
- Known history of, or symptomatic metastatic brain or meningeal tumors
- History of cardiac disease
- Active clinically serious infections
- Clinically significant (ie. symptomatic) peripheral vascular disease
- Pregnant or lactating women; women of childbearing potential not employing adequate contraception
- Use of strong inhibitors or inducers of CYP3A4
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- Prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignancy
- Previous gemcitabine or 5-fluorouracil (5-FU) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment
- Thrombotic or embolic events such within 6 months prior to start of study treatment
Trial locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
Germany5 sites
Study site
Berlin, 13353
Study site
Bochum, North Rhine-Westphalia, 44892
Study site
Heilbronn, Baden-Wurttemberg, 74078
Study site
Marburg, Hesse, 35033
Study site
München, Bavaria, 81377
Belgium3 sites
Study site
Bruxelles - Brussel, 1070
Study site
Bruxelles - Brussel, 1090
Study site
Edegem, 2650
Poland3 sites
Study site
Bialystok, 15-027
Study site
Gdansk, 80-952
Study site
Warsaw, 02-781
United Kingdom3 sites
Study site
London, SE1 9RT
Study site
London, WC1E 6BT
Study site
London
United States2 sites
Study site
Aurora, Colorado, 80045
Study site
Pittsfield, Massachusetts, 01201
Italy2 sites
Study site
Ancona, The Marches, 60126
Study site
Brescia, Lombardy, 25124
About this study
Official title: A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.
Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.
Read more
Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.
Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.
- Conditions
- Pancreatic Neoplasms
- Being tested
- BAY86-9766+Gemcitabine
- Keywords
- pancreatic cancer,, MEK-inhibitor
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY86-9766+GemcitabineDrug
Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY86-9766+Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
Measured: From randomization up to the first 8 weeks of therapy
Tumor Response (Adjudicated Blinded Read Assessment): Phase II
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Secondary outcomes (11)
Tumor Response: Investigator Assessment: Phase I
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase I
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase II
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response (DOR): Phase I
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response: Phase II
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase I
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase II
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase I
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase II
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase I
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase II
Measured: From start of treatment until 134 weeks assessed every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study start1 Jan 2011
- Primary completion11 Feb 2013
- Study completion1 Aug 2013
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 BayerThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251640
- Sponsor's protocol ID
- 14905
- Other IDs
- 2010-019588-12
- Acronym
- BAGPAC
- Status last verified
- Apr 2021
- First submitted
- 8 Nov 2010
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Phase I/II Study of BAY86-9766 in Combination With Gemcitabine in Patients With Locally Advanced Inoperable or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01251640
- Acronym / sponsor ID
- BAGPAC / 14905
- Conditions
- Pancreatic Neoplasms
- Keywords
- pancreatic cancer,, MEK-inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 11 Feb 2013 (actual)
- Study completion
- 1 Aug 2013 (actual)
- First posted
- 2 Dec 2010 (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.
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.
Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.
Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability.
Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and weekly throughout the study; Safety follow-up visit 30 days after the last dose of study treatment; Survival follow up monthly for up to 8 month after LPFV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY86-9766+Gemcitabine |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients ≥18 years of age
- Histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery
- Patients must have at least one uni-dimensional measurable lesion by CT or MRI according to RECIST, Version 1.1
- Resolution of all acute toxic effects of any prior local treatment to Common Terminology Criteria for Adverse Events (CTCAE) Grade </= 1
- Eastern Cooperative Oncology Group performance status (ECOG PS) </= 2
Key exclusion criteria (9 listed)
- Known history of, or symptomatic metastatic brain or meningeal tumors
- History of cardiac disease
- Active clinically serious infections
- Clinically significant (ie. symptomatic) peripheral vascular disease
- Pregnant or lactating women; women of childbearing potential not employing adequate contraception
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 |
|---|---|---|
| BAY86-9766+GemcitabinePhase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent) | Drug | Arm 1 |
Primary outcome
Number of Subjects With Dose Limiting Toxicities (DLT): Phase I
Time frame: From randomization up to the first 8 weeks of therapy
Tumor Response (Adjudicated Blinded Read Assessment): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
11 secondary outcomes
Tumor Response: Investigator Assessment: Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Disease Control (DC): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response (DOR): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Duration of Response: Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Time to Progression (TTP): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Progression-Free Survival (PFS): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase I
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
Overall Survival (OS): Phase II
Time frame: From start of treatment until 134 weeks assessed every 8 weeks
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 8 Apr 2021.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BAY86-9766+Gemcitabine in people with Pancreatic Neoplasms, run by Bayer at 23 sites in 9 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 6 inclusion and 9 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Belgium, Poland, United Kingdom, United States and 4 more countries. 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 combined 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.
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?
Number of Subjects With Dose Limiting Toxicities (DLT): Phase I (time frame: From randomization up to the first 8 weeks of therapy). The study lists 2 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 8 Apr 2021.