Metastatic Pancreatic CancerPhase 2ALPACANCT02564146
First-line Treatment of Metastatic Pancreatic Cancer With Nab-paclitaxel and Gemcitabine
A Phase 2 study testing nab-paclitaxel and gemcitabine and gemcitabine mono and nab-paclitaxel and gemcitabine in people with Metastatic Pancreatic Cancer and Adenocarcinoma of the Pancreas, run by AIO-Studien-gGmbH at 1 site in Germany.
Trial summary
ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II trial with two arms. To estimate the treatment effect on overall survival, feasibility, efficacy and safety of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer, Adenocarcinoma of the Pancreas
- What is being tested?
- nab-paclitaxel and gemcitabine and gemcitabine mono and nab-paclitaxel and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to May 2022
- 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
- Adult patients (≥ 18 years of age)
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
- Karnofsky Perfomance Status (KPS) ≥ 70%
- At least one unidimensionally measurable lesion as assessed by CT- scan or Magnetic resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors (RECIST1.1 ),
- Total bilirubin ≤ 1.5 x ULN (Upper Limit of Normal). 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.
- Adequate renal, hepatic and bone marrow function, defined as
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- Calculated creatinine clearance ≥ 30 mL/min according to CKD-EPI formula (Chronic kidney Disease Epidemiology Collaboration)
- AST/GOT and/or ALT/GPT ≤ 2.5 x ULN and ≤ 5.0 x ULN in case of liver metastasis
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Haemoglobin ≥ 9 g/dL
- Platelets ≥ 100 x 100 x 10^9/L
- Females of Childbearing Potential (FCBP) must have a negative serum pregnancy test within 7 days of the first application of study treatment and they must agree to undergo further pregnancy tests before randomization and at the end of treatment visit and
- FCBP must either agree to use and be able to take effective contraceptive birth control measures (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 is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 years, or unless she is surgically sterile.
- Males must agree not to father a child during the course of the trial and for at least 6 months after last administration of study drugs.
- 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
- Missing histological or cytological confirmation of metastatic adenocarcinoma of the pancreas Locally advanced pancreatic adenocarcinoma without metastases Any previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. (Prior adjuvant chemotherapy with gemcitabine or fluoropyrimidine in curative intent is allowed if terminated more than 6 months before first application of study treatment. Previous palliative radiotherapy of bonemetastases for alleviation of pain is permitted provided that irradiated bone metastases are no target lesions.) Known brain metastase/brain metastases. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- Pre-existing peripheral neuropathy ≥ grade 2 according to CTCAE version 4 (Common Terminology Criteria for Adverse Events)
- • Medical history of interstitial lung disease (ILD) or pulmonary fibrosis
- Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- 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. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders Previous or concurrent tumor other than underlying tumor disease (pancreatic cancer) with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated tumors > 5 years prior to enrolment Hypersensitivity against nab-paclitaxel, gemcitabine, or any excipients of these drugs
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- Continuing abuse of alcohol, drugs, or medical drugs
- Pregnant females, breast feeding females or females of childbearing potential unable to perform adequate contraceptive measures or practice complete abstinence from heterosexual intercourse
- Participation in any other clinical trial or treatment with any experimental drug within 28 days before enrolment to the study or during study participation until the end of treatment visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction Treatment With Nab-paclitaxel/Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer Followed by Either Alternating Application of Gemcitabine Monotherapy and Nab-paclitaxel/Gemcitabine or Continuing Application of Nab-paclitaxel/Gemcitabine: A Randomized Phase II Study
ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II trial with two arms.
To estimate the treatment effect on overall survival, feasibility, efficacy and safety of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.
Read the detailed description
ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II trial with two arms.
To estimate the treatment effect on overall survival, feasibility, efficacy and safety of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.
- Being tested
- nab-paclitaxel and gemcitabine, gemcitabine mono and nab-paclitaxel and gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxel and gemcitabineDrug
Induction treatment:
3 cycles nab-paclitaxel and gemcitabine 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.
Continouous treatment after randomization:
Continuing application of nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity. Duration of each cycle is 28 days nab-paclitaxel 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.
gemcitabine mono and nab-paclitaxel and gemcitabineDrug
Induction treatment:
3 cycles nab-paclitaxel and gemcitabine 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.
Continouous treatment after randomization:
Alternating application of gemcitabine monotherapy and nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity, starting with a treatment cycle of gemcitabine monotherapy.
Duration of each cycle irrespective of treatment cycle with gemcitabine monotherapy or treatment with nab-paclitaxel/gemcitabine is 28 days.
Gemcitabine monotherapy treatment cycle: Gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.
Nab-paclitaxel and gemcitabine treatment cycle: Nab-paclitaxel 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel and gemcitabine (A) | Active comparator | Induction treatment: 3 cycles nab-paclitaxel and gemcitabine
Continuous treatment after randomization: Continuing application of nab-paclitaxel and gemcitabine treatment cycles Receives: Drug: nab-paclitaxel and gemcitabine |
| gemcitabine monotherapy and nab-paclitaxel and gemcitabine (B) | Experimental | Induction treatment: 3 cycles nab-paclitaxel and gemcitabine
Continuous treatment after randomization: alternating application of gemcitabine monotherapy and nab-paclitaxel and gemcitabine treatment cycles Receives: Drug: nab-paclitaxel and gemcitabine; Drug: gemcitabine mono and nab-paclitaxel and gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
To estimate the treatment effect of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine treatment cycles in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.
Measured: After randomization until date of death or end of study wichever comes first. Assessed for up to 38.5 month
Secondary outcomes (17)
Overall survival (OS)
During induction phase.
Measured: 3.5 month
Overall survival (OS)
Determined from first application of induction treatment.
Measured: 42 month
Progression-free survival (PFS)
During induction phase.
Measured: 3.5 month
Progression-free survival (PFS)
As time from randomization to objective tumor progression or death from any cause.
Measured: Assessed for up to 38.5 month
Progression-free survival (PFS)
As time from randomization to objective tumor progression or death from any cause.
Measured: Assessed for up to 42 month
Overall response rate (ORR)
According to RECISTv1.1 determined from first application of induction treatment.
Measured: Assessed for up to 42 month
Overall response rate (ORR)
During induction phase.
Measured: Assessed for up to 3.5 month
Disease control rate (DCR)
According to RECISTv1.1 determined from first application of induction treatment.
Measured: Assessed for up to 42 month
Disease control rate (DCR)
During induction phase.
Measured: Assessed for up to 3.5 month
Quality of life QLQ-C30
During induction phase.
Measured: Assessed for up to 3.5 month
Quality of life QLQ-C30
As determined with EORTC QLQ-C30 determined from randomization.
Measured: Assessed for up to 8 month
Adverse Events (AE)
Type, incidence, and severity according to NCI CTCAE version 4 with explicit consideration of any neurotoxicity.
Measured: Assessed for up to 11.5 month
Adverse Events (AE)
Type, incidence, and severity according to NCI CTCAE version 4 with explicit consideration of any neurotoxicity during induction phase.
Measured: Assessed for up to 3.5 month
Time of treatment without toxicity
Duration of treatment without toxicity leading to permanent discontinuation during induction and randomized phase.
Measured: Assessed for up to 11.5 month
Time of treatment without toxicity
Duration of treatment during induction phase.
Measured: Assessed for up to 3.5 month
Neurotoxicity Assessment FACT taxane score
Functional assessment of neurotoxicity (with FACT taxane score) during induction and randomized phase.
Measured: Assessed for up to 11.5 month
Neurotoxicity Assessment FACT taxane score
Functional assessment of neurotoxicity (with FACT taxane score) during induction phase.
Measured: Assessed for up to 3.5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startDec 2016
- Primary completionMar 2022
- Study completionMay 2022
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIO-Studien-gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- ClinAssess GmbH, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Frank Kullmann, Prof. Dr., Principal investigator, Kliniken Nordoberpfalz AG Klinikum Weiden Medizinische Kliniken I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564146
- Sponsor's protocol ID
- AIO-PAK-0114
- Other IDs
- 2014-004086-24, AX-CL-PANC-AIO-004415, 2014
- Acronym
- ALPACA
- Status last verified
- Nov 2022
- First submitted
- 29 Sep 2015
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dorman K, Boeck S, Caca K, Reichert M, Ettrich TJ, Oettle H, Waidmann O, Modest DP, Muller L, Michl P, Kanzler S, Pink D, Reinacher-Schick A, Geissler M, Pelz H, Kunzmann V, Held S, Schichtl T, Heinemann V, Kullmann F. Alternating gemcitabine plus nab-paclitaxel and gemcitabine alone versus continuous gemcitabine plus nab-paclitaxel after induction treatment of metastatic pancreatic cancer (ALPACA): a multicentre, randomised, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):935-943. doi: 10.1016/S2468-1253(24)00197-3. Epub 2024 Aug 16.
PubMed 39159648
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Treatment With Nab-paclitaxel/Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer Followed by Either Alternating Application of Gemcitabine Monotherapy and Nab-paclitaxel/Gemcitabine or Continuing Application of Nab-paclitaxel/Gemcitabine: A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT02564146
- Acronym / sponsor ID
- ALPACA / AIO-PAK-0114
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- AIO-Studien-gGmbHUniversity, hospital or other
- Collaborators
- ClinAssess GmbH, Celgene Corporation
- Study start
- Dec 2016
- Primary completion
- Mar 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 30 Sep 2015 (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.
ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II trial with two arms.
To estimate the treatment effect on overall survival, feasibility, efficacy and safety of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.
Detailed description
ALPACA is an interventional, multicentre, open-label, randomized active-controlled phase II trial with two arms.
To estimate the treatment effect on overall survival, feasibility, efficacy and safety of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine cycles in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel and gemcitabine (A) | Active comparator | Drug: nab-paclitaxel and gemcitabineInduction treatment: 3 cycles nab-paclitaxel and gemcitabine Continuous treatment after randomization: Continuing application of nab-paclitaxel and gemcitabine treatment cycles |
| gemcitabine monotherapy and nab-paclitaxel and gemcitabine (B) | Experimental | Drug: nab-paclitaxel and gemcitabine, Drug: gemcitabine mono and nab-paclitaxel and gemcitabineInduction treatment: 3 cycles nab-paclitaxel and gemcitabine Continuous treatment after randomization: alternating application of gemcitabine monotherapy and nab-paclitaxel and gemcitabine treatment cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adult patients (≥ 18 years of age)
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
- Karnofsky Perfomance Status (KPS) ≥ 70%
- At least one unidimensionally measurable lesion as assessed by CT- scan or Magnetic resonance imaging (MRI) according to Response Evaluation Criteria In Solid Tumors (RECIST1.1 ),
- Total bilirubin ≤ 1.5 x ULN (Upper Limit of Normal). 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.
Key exclusion criteria (9 listed)
- Missing histological or cytological confirmation of metastatic adenocarcinoma of the pancreas Locally advanced pancreatic adenocarcinoma without metastases Any previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. (Prior adjuvant chemotherapy with gemcitabine or fluoropyrimidine in curative intent is allowed if terminated more than 6 months before first application of study treatment. Previous palliative radiotherapy of bonemetastases for alleviation of pain is permitted provided that irradiated bone metastases are no target lesions.) Known brain metastase/brain metastases. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- Pre-existing peripheral neuropathy ≥ grade 2 according to CTCAE version 4 (Common Terminology Criteria for Adverse Events)
- • Medical history of interstitial lung disease (ILD) or pulmonary fibrosis
- Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
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 |
|---|---|---|
| nab-paclitaxel and gemcitabineInduction treatment: 3 cycles nab-paclitaxel and gemcitabine 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle. Continouous treatment after randomization: Continuing application of nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity. Duration of each cycle is 28 days nab-paclitaxel 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle. | Drug | gemcitabine monotherapy and nab-paclitaxel and gemcitabine (B), nab-paclitaxel and gemcitabine (A) |
| gemcitabine mono and nab-paclitaxel and gemcitabineInduction treatment: 3 cycles nab-paclitaxel and gemcitabine 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle. Continouous treatment after randomization: Alternating application of gemcitabine monotherapy and nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity, starting with a treatment cycle of gemcitabine monotherapy. Duration of each cycle irrespective of treatment cycle with gemcitabine monotherapy or treatment with nab-paclitaxel/gemcitabine is 28 days. Gemcitabine monotherapy treatment cycle: Gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle. Nab-paclitaxel and gemcitabine treatment cycle: Nab-paclitaxel 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle. | Drug | gemcitabine monotherapy and nab-paclitaxel and gemcitabine (B) |
Primary outcome
Overall survival (OS)
Time frame: After randomization until date of death or end of study wichever comes first. Assessed for up to 38.5 month
To estimate the treatment effect of alternating treatment cycles of gemcitabine monotherapy followed by nab-paclitaxel/gemcitabine relative to standard continuing nab-paclitaxel/gemcitabine treatment cycles in first-line treatment for metastatic pancreatic cancer in patients having received 3 cycles of induction therapy with standard nab-paclitaxel/gemcitabine.
17 secondary outcomes
Overall survival (OS)
Time frame: 3.5 month
Overall survival (OS)
Time frame: 42 month
Progression-free survival (PFS)
Time frame: 3.5 month
Progression-free survival (PFS)
Time frame: Assessed for up to 38.5 month
Progression-free survival (PFS)
Time frame: Assessed for up to 42 month
Overall response rate (ORR)
Time frame: Assessed for up to 42 month
Overall response rate (ORR)
Time frame: Assessed for up to 3.5 month
Disease control rate (DCR)
Time frame: Assessed for up to 42 month
Disease control rate (DCR)
Time frame: Assessed for up to 3.5 month
Quality of life QLQ-C30
Time frame: Assessed for up to 3.5 month
Quality of life QLQ-C30
Time frame: Assessed for up to 8 month
Adverse Events (AE)
Time frame: Assessed for up to 11.5 month
Adverse Events (AE)
Time frame: Assessed for up to 3.5 month
Time of treatment without toxicity
Time frame: Assessed for up to 11.5 month
Time of treatment without toxicity
Time frame: Assessed for up to 3.5 month
Neurotoxicity Assessment FACT taxane score
Time frame: Assessed for up to 11.5 month
Neurotoxicity Assessment FACT taxane score
Time frame: Assessed for up to 3.5 month
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 22 Nov 2022.
- Derived from this study: PubMed 39159648Dorman K, Boeck S, Caca K, Reichert M, Ettrich TJ, Oettle H, Waidmann O, Modest DP, Muller L, Michl P, Kanzler S, Pink D, Reinacher-Schick A, Geissler M, Pelz H, Kunzmann V, Held S, Schichtl T, Heinemann V, Kullmann F. Alternating gemcitabine plus nab-paclitaxel and gemcitabine alone versus continuous gemcitabine plus nab-paclitaxel after induction treatment of metastatic pancreatic cancer (ALPACA): a multicentre, randomised, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):935-943. doi: 10.1016/S2468-1253(24)00197-3. Epub 2024 Aug 16.
- 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.
Frank Kullmann, Prof. Dr. principal investigator
Kliniken Nordoberpfalz AG Klinikum Weiden Medizinische Kliniken I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-paclitaxel and gemcitabine and gemcitabine mono and nab-paclitaxel and gemcitabine in people with Metastatic Pancreatic Cancer and Adenocarcinoma of the Pancreas, run by AIO-Studien-gGmbH 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 15 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 22 Nov 2022. 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 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?
Overall survival (OS) (time frame: After randomization until date of death or end of study wichever comes first. Assessed for up to 38.5 month). 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 NCT02564146, 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 22 Nov 2022.