Metastatic Pancreatic CancerPhase 1AFFECTNCT02975141
Afatinib and Gemcitabine/Nab-paclitaxel in Metastatic Pancreatic Cancer
A Phase 1 study testing Afatinib 30Mg Tab, Afatinib 40Mg Tab and Gemzar in people with Metastatic Pancreatic Cancer, run by PD Dr. med. Volker Heinemann at 1 site in Germany.
Trial summary
This study sets out to determine the maximum tolerated dose (MTD) of afatinib in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. The identified MTD will serve as recommended phase II dose (RP2D). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Afatinib 30Mg Tab, Afatinib 40Mg Tab and Gemzar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Jun 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years of age and ≤ 75 years
- Histologically (not cytologically) confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC) [Stage IV according to UICC TNM edition 7 of 2009: each T, each N, M1]
- No option for surgical resection or radiation in curative intent
- At least one unidimensionally measurable tumor lesion (according to RECIST 1.1)
- ECOG performance status 0 - 1
- Life expectancy at least 3 months
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- Adequate hepatic, renal and bone marrow function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.5x109/L
- Haemoglobin ≥ 9 g/dL 9
- Thrombocytes ≥100x10/L
- Total bilirubin ≤ 1.5xULN.
- Patients with a biliary stent may be included provided that bilirubin level after stent insertion decreased to ≤ 1.5 x ULN and there is no cholangitis.
- AST/GOT and/or ALT/GPT ≤ 2.5 x ULN or in case of liver metastasis ≤ 5 x ULN)
- Serum creatinine within normal limits or creatinine clearance ≥60 mL/min/1.73 m2 as calculated by CKD- EPI formula for patients with serum creatinine levels above or below the institutional normal value.
- Acceptable coagulation studies defined as prothrombin time (or INR) and PTT ≤ 1.5 x ULN
- Stable/decreasing pain symptoms under pain medication or no pain within the last 2 weeks before first application of study medication (as reported and assessed by the patient).
- Females of childbearing potential (FCBP) must have a negative highly sensitive serum pregnancy test within 7 days of the first application of study treatment and they must agree to undergo a further pregnancy tests at monthly intervals and at the end of treatment visit and FCBP must either agree to use and be able to take highly effective contraceptive birth control methods (Pearl Index < 1) or agree to practice complete abstinence from heterosexual intercourse during the course of the study and for at least 1 month after last application of study treatment. A female subject following menarche is considered to be of childbearing potential unless she is naturally amenorrhoeic for ≥ 1 year without an alternative medical reason, or unless she is permanently sterile.
- Males must agree to use condoms during the course of the trial and for at least 6 months after last administration of study drugs or practice complete abstinence from heterosexual intercourse.
- Signed and dated informed consent before the start of any specific protocol procedures
- Patient's legal capacity to consent to study participation
Who cannot join
- Locally advanced PDAC without metastasis
- Evidence of ascites
- Known metastatic disease to the brain. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- Previous palliative chemotherapy or other palliative systemic tumor therapy for metastatic disease of PDAC
- Previous gemcitabine treatment with exception of gemcitabine treatment applied as monotherapy in the adjuvant setting (after potential curative R0 or R1 resection) and if the adjuvant single-agent gemcitabine chemotherapy was terminated at least 6 months before study entry
- Previous radiotherapy of PDAC
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- Previous ErbB family directed therapy for PDAC (e. g. erlotinib, cetuximab, trastuzumab, lapatinib)
- Any major surgery within the last 4 weeks before study entry
- Clinical significant decrease in performance status within 2 weeks of intended first application of study medication (by medical history)
- Severe tumor-related cachexia and/or known weight loss >15% within one month before study enrollment
- Pre-existing polyneuropathy ≥ grade 2 according to CTCAE version 4.03
- LDH >2.5xULN
- Significant (≥ 20%) decrease in serum albumin levels within 2 weeks of intended first application of study medication (by medical history)
- Gastrointestinal disorders that might interfere with the absorption of the study drug and gastrointestinal disorders with diarrhoea as a major symptom (e.g. Crohn's disease, malabsorption), and chronic diarrhoea of any aetiology CTCAE version 4.03 grade ≥ 2
- Medical history of interstitial lung disease (ILD) or pulmonary fibrosis or severe COPD
- Liver cirrhosis Child-Pugh other than class A
- Known coagulopathy or bleeding disorder
- History of connective tissue disorders (e.g. lupus, scleroderma,arteritis nods)
- Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the study and his/her safety during the study or interfere with interpretation of study results e.g. active infection, uncontrolled hypertension, clinically significant cardiovascular disease e.g. cerebral vascular accident (≤ 6 months before study start), myocardial infarction (≤ 6 months before study start), unstable angina, heart failure ≥ NYHA functional classification system grade 2, severe cardiac arrhythmia requiring medication, metabolic dysfunction, severe renal disorder.
- Any other malignancies than PDAC within the last 5 years before study start, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer
- Hypersensitivity to afatinib, nab-paclitaxel, or gemcitabine or to any of the excipients or to compounds with similar chemical or biologic composition
- Continuing abuse of alcohol,drugs,or medical drugs
- Pregnant or breast-feeding females or FCBPs unable to either perform highly effective contraceptive measures or practice complete abstinence from heterosexual intercourse
- Current or recent (within 4 weeks prior to first application of study treatment) treatment with an investigational drug or participation in an investigational clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gemcitabine and Nab-Paclitaxel Combined With the Oral Irreversible ErbB Family Blocker Afatinib in Patients With Metastatic Pancreatic Cancer: A Phase Ib Trial
This study sets out to determine the maximum tolerated dose (MTD) of afatinib in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. The identified MTD will serve as recommended phase II dose (RP2D).
Read the detailed description
Pancreatic ductal adenocarcinoma (PDAC) remains an almost uniformly lethal disease. Although there has been significant progress in understanding of the underlying molecular biology of pancreatic cancer, this progress has not translated into substantially better treatments. Alarmingly, the number of pancreatic cancer cases is constantly rising and pancreatic cancer will be the second most frequent cause of cancer related death by 2030.
Accordingly, novel therapeutic strategies for patients with pancreatic cancer are desperately needed.
Recently, the combination of gemcitabine and nab-paclitaxel proofed to be superior when compared to single agent gemcitabine (overall survival [OS] 8.7 months in the nab-paclitaxel/gemcitabine group versus 6.6 months in the gemcitabine group; hazard ratio for death, 0.72; 95% confidence interval [CI], 0.62 to 0.83; P<0.001). Consequently, this combination therapy is now regarded as a novel treatment option for patient with metastatic pancreatic cancer and should therefore serve as a backbone for future clinical studies.
Preclinical studies suggest a significant role for ErbB signaling in the pathogenesis of pancreatic cancer. Accordingly, targeting the family of ErbB receptor tyrosine kinases seems to be a viable option to improve the outcome of patients with pancreatic cancer. Addition of the selective reversible EGFR tyrosine kinase inhibitor erlotinib to gemcitabine significantly improved progression-free survival and overall survival in metastatic pancreatic cancer patients. However, the effect on median survival time in absolute values between the two arms (erlotinib and gemcitabine versus gemcitabine alone) accounted for less than a half month.
Afatinib is a selective, potent and irreversible ErbB family blocker. Unlike erlotinib, afatinib covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4. Afatinib is applied orally once daily. Preclinical studies suggest that application of afatinib should result in greater efficacy against tumor growth than application of erlotinib.
Afatinib as monotherapy has a marketing authorization for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation/mutations for daily doses up to 50 mg once daily. In a Phase I trial for safety and tolerability of afatinib in combination with gemcitabine in patients with advanced solid tumors the maximum tolerated dose (MTD) was 40 mg afatinib (given continuously once daily) plus 1000 mg/m2 gemcitabine on D1 and D8 of a 21-day cycle, with no dose-limiting toxicity in the respective cohort. Accordingly, in another current Phase II trial of the sponsor for treatment of metastatic pancreatic cancer the dose of 40 mg continuously orally once daily given afatinib in combination with 1000 mg/m2 gemcitabine given on Day1, Day 8, and Day 15 of a 28-day cycle against monotherapy with gemcitabine 1000 mg/m2 is used.
The investigators hypothesize that addition of afatinib to gemcitabine/nab-paclitaxel might result in better anti-tumor activity.
Accordingly, the aim of this trial is to establish the MTD for afatinib in combination with gemcitabine/nab-paclitaxel in order to proceed into Phase II trials.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Afatinib 30Mg Tab, Afatinib 40Mg Tab, Gemzar, Abraxane
- Keywords
- Palliative Chemotherapy, Afatinib, Gemcitabine, nab-paclitaxel, pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afatinib 30Mg TabDrug
Also called Giotrif
Study Drug
Afatinib 40Mg TabDrug
Also called Giotrif
Study Drug
GemzarDrug
Also called Gemcitabine
Chemotherapy Backbone
AbraxaneDrug
Also called nab-Paclitaxel
Chemotherapy Backbone
| Study group | Role | What they receive |
|---|---|---|
| Afatinib 40Mg Tab, Gemzar, Abraxane +1 | Experimental | Dose Level +1 Afatinib 40 mg Nab-paclitaxel 125 mg/m2 BSA Gemcitabine 1000 mg/m2 BSA Receives: Drug: Afatinib 40Mg Tab; Drug: Gemzar; Drug: Abraxane |
| Afatinib 30Mg Tab, Gemzar, Abraxane 0 | Experimental | Dose Level 0 Afatinib 30 mg Nab-paclitaxel 125 mg/m2 BSA Gemcitabine 1000 mg/m2 BSA Receives: Drug: Afatinib 30Mg Tab; Drug: Gemzar; Drug: Abraxane |
| Afatinib 30Mg Tab, Gemzar, Abraxane -1 | Experimental | Dose Level -1 Afatinib 30 mg Nab-paclitaxel 100 mg/m2 BSA Gemcitabine 800 mg/m2 BSA Receives: Drug: Afatinib 30Mg Tab; Drug: Gemzar; Drug: Abraxane |
| Afatinib 30Mg Tab, Gemzar, Abraxane -2 | Experimental | Dose Level -2 Afatinib 30 mg Nab-paclitaxel 75 mg/m2 BSA Gemcitabine 600 mg/m2 BSA Receives: Drug: Afatinib 30Mg Tab; Drug: Gemzar; Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of afatinib in combination with gemcitabine/nab-paclitaxel
Completion of the first cycle of chemotherapy
Measured: 28 days after the first dose of chemotherapy
Secondary outcomes (4)
RECIST measurements of target lesions (in cm/inches)
Objective Response Rate
Measured: 18 months
Progression free survival (in months)
PFS
Measured: 18 months
Overall survival (in months)
OS
Measured: 18 months
Incidence of Treatment-Emergent Adverse Events
Type, incidence, and severity of adverse events according to NCI CTCAE version 4.03. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- PD Dr. med. Volker Heinemann
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, University of Cologne
- Responsible party
- Sponsor-investigator, PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich
- Investigators
- Volker Heinemann, Professor, Principal investigator, University of Munich - Klinikum Großhadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975141
- Sponsor's protocol ID
- 2015-004065-86
- Other IDs
- 2015
- Acronym
- AFFECT
- Status last verified
- Aug 2018
- First submitted
- 21 Sep 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine and Nab-Paclitaxel Combined With the Oral Irreversible ErbB Family Blocker Afatinib in Patients With Metastatic Pancreatic Cancer: A Phase Ib Trial
- ClinicalTrials.gov ID
- NCT02975141
- Acronym / sponsor ID
- AFFECT / 2015-004065-86
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Palliative Chemotherapy, Afatinib, Gemcitabine, nab-paclitaxel, pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PD Dr. med. Volker HeinemannUniversity, hospital or other
- Collaborators
- Technical University of Munich, University of Cologne
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 29 Nov 2016 (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.
This study sets out to determine the maximum tolerated dose (MTD) of afatinib in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. The identified MTD will serve as recommended phase II dose (RP2D).
Detailed description
Pancreatic ductal adenocarcinoma (PDAC) remains an almost uniformly lethal disease. Although there has been significant progress in understanding of the underlying molecular biology of pancreatic cancer, this progress has not translated into substantially better treatments. Alarmingly, the number of pancreatic cancer cases is constantly rising and pancreatic cancer will be the second most frequent cause of cancer related death by 2030.
Accordingly, novel therapeutic strategies for patients with pancreatic cancer are desperately needed.
Recently, the combination of gemcitabine and nab-paclitaxel proofed to be superior when compared to single agent gemcitabine (overall survival [OS] 8.7 months in the nab-paclitaxel/gemcitabine group versus 6.6 months in the gemcitabine group; hazard ratio for death, 0.72; 95% confidence interval [CI], 0.62 to 0.83; P<0.001). Consequently, this combination therapy is now regarded as a novel treatment option for patient with metastatic pancreatic cancer and should therefore serve as a backbone for future clinical studies.
Preclinical studies suggest a significant role for ErbB signaling in the pathogenesis of pancreatic cancer. Accordingly, targeting the family of ErbB receptor tyrosine kinases seems to be a viable option to improve the outcome of patients with pancreatic cancer. Addition of the selective reversible EGFR tyrosine kinase inhibitor erlotinib to gemcitabine significantly improved progression-free survival and overall survival in metastatic pancreatic cancer patients. However, the effect on median survival time in absolute values between the two arms (erlotinib and gemcitabine versus gemcitabine alone) accounted for less than a half month.
Afatinib is a selective, potent and irreversible ErbB family blocker. Unlike erlotinib, afatinib covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4. Afatinib is applied orally once daily. Preclinical studies suggest that application of afatinib should result in greater efficacy against tumor growth than application of erlotinib.
Afatinib as monotherapy has a marketing authorization for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation/mutations for daily doses up to 50 mg once daily. In a Phase I trial for safety and tolerability of afatinib in combination with gemcitabine in patients with advanced solid tumors the maximum tolerated dose (MTD) was 40 mg afatinib (given continuously once daily) plus 1000 mg/m2 gemcitabine on D1 and D8 of a 21-day cycle, with no dose-limiting toxicity in the respective cohort. Accordingly, in another current Phase II trial of the sponsor for treatment of metastatic pancreatic cancer the dose of 40 mg continuously orally once daily given afatinib in combination with 1000 mg/m2 gemcitabine given on Day1, Day 8, and Day 15 of a 28-day cycle against monotherapy with gemcitabine 1000 mg/m2 is used.
The investigators hypothesize that addition of afatinib to gemcitabine/nab-paclitaxel might result in better anti-tumor activity.
Accordingly, the aim of this trial is to establish the MTD for afatinib in combination with gemcitabine/nab-paclitaxel in order to proceed into Phase II trials.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Afatinib 40Mg Tab, Gemzar, Abraxane +1 | Experimental | Drug: Afatinib 40Mg Tab, Drug: Gemzar, Drug: AbraxaneDose Level +1 Afatinib 40 mg Nab-paclitaxel 125 mg/m2 BSA Gemcitabine 1000 mg/m2 BSA |
| Afatinib 30Mg Tab, Gemzar, Abraxane 0 | Experimental | Drug: Afatinib 30Mg Tab, Drug: Gemzar, Drug: AbraxaneDose Level 0 Afatinib 30 mg Nab-paclitaxel 125 mg/m2 BSA Gemcitabine 1000 mg/m2 BSA |
| Afatinib 30Mg Tab, Gemzar, Abraxane -1 | Experimental | Drug: Afatinib 30Mg Tab, Drug: Gemzar, Drug: AbraxaneDose Level -1 Afatinib 30 mg Nab-paclitaxel 100 mg/m2 BSA Gemcitabine 800 mg/m2 BSA |
| Afatinib 30Mg Tab, Gemzar, Abraxane -2 | Experimental | Drug: Afatinib 30Mg Tab, Drug: Gemzar, Drug: AbraxaneDose Level -2 Afatinib 30 mg Nab-paclitaxel 75 mg/m2 BSA Gemcitabine 600 mg/m2 BSA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult patients ≥ 18 years of age and ≤ 75 years
- Histologically (not cytologically) confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC) [Stage IV according to UICC TNM edition 7 of 2009: each T, each N, M1]
- No option for surgical resection or radiation in curative intent
- At least one unidimensionally measurable tumor lesion (according to RECIST 1.1)
- ECOG performance status 0 - 1
Key exclusion criteria (24 listed)
- Locally advanced PDAC without metastasis
- Evidence of ascites
- Known metastatic disease to the brain. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- Previous palliative chemotherapy or other palliative systemic tumor therapy for metastatic disease of PDAC
- Previous gemcitabine treatment with exception of gemcitabine treatment applied as monotherapy in the adjuvant setting (after potential curative R0 or R1 resection) and if the adjuvant single-agent gemcitabine chemotherapy was terminated at least 6 months before study entry
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 |
|---|---|---|
| Afatinib 30Mg TabAlso: GiotrifStudy Drug | Drug | Afatinib 30Mg Tab, Gemzar, Abraxane -1, Afatinib 30Mg Tab, Gemzar, Abraxane -2, Afatinib 30Mg Tab, Gemzar, Abraxane 0 |
| Afatinib 40Mg TabAlso: GiotrifStudy Drug | Drug | Afatinib 40Mg Tab, Gemzar, Abraxane +1 |
| GemzarAlso: GemcitabineChemotherapy Backbone | Drug | Afatinib 30Mg Tab, Gemzar, Abraxane -1, Afatinib 30Mg Tab, Gemzar, Abraxane -2, Afatinib 30Mg Tab, Gemzar, Abraxane 0, Afatinib 40Mg Tab, Gemzar, Abraxane +1 |
| AbraxaneAlso: nab-PaclitaxelChemotherapy Backbone | Drug | Afatinib 30Mg Tab, Gemzar, Abraxane -1, Afatinib 30Mg Tab, Gemzar, Abraxane -2, Afatinib 30Mg Tab, Gemzar, Abraxane 0, Afatinib 40Mg Tab, Gemzar, Abraxane +1 |
Primary outcome
MTD of afatinib in combination with gemcitabine/nab-paclitaxel
Time frame: 28 days after the first dose of chemotherapy
Completion of the first cycle of chemotherapy
4 secondary outcomes
RECIST measurements of target lesions (in cm/inches)
Time frame: 18 months
Progression free survival (in months)
Time frame: 18 months
Overall survival (in months)
Time frame: 18 months
Incidence of Treatment-Emergent Adverse Events
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- 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.
Volker Heinemann, Professor principal investigator
University of Munich - Klinikum Großhadern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Afatinib 30Mg Tab, Afatinib 40Mg Tab and Gemzar in people with Metastatic Pancreatic Cancer, run by PD Dr. med. Volker Heinemann 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 20 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: status not confirmed, as of the sponsor's last update on 13 Aug 2018. 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. 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?
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?
MTD of afatinib in combination with gemcitabine/nab-paclitaxel (time frame: 28 days after the first dose of chemotherapy). 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 2018.