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Adenocarcinoma PancreasPhase 4GrantPaxNCT02812992

Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients

A Phase 4 study testing Nab-paclitaxel and Gemcitabine in people with Adenocarcinoma Pancreas, run by AIO-Studien-gGmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The GrantPax study is a multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/- nab-paclitaxel in elderly pancreatic cancer patients. The primary objective is that CGA-stratified patients do not decline in their CGA performance in response to chemotherapy measured as a loss of five points… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Adenocarcinoma Pancreas
What is being tested?
Nab-paclitaxel and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteGermany
Study dates
Jun 2016to Feb 2021
Phase
Phase 4
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients ≥ 70 years of age.
  • Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
  • At least one measurable lesion of disease according to RECIST 1.1 criteria.
  • No prior chemotherapy (except fluoruracil or gemcitabine in an adjuvant setting at least > 6 months prior enrollment).
  • Adequate end organ function:
  • renal function: serum creatinine ≤ 1.5 x ULN or GFR ≥ 30mL/min.
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  • hematopoietic function: white blood cell (WBC) count ≥3000/μL, absolute neutrophil count (ANC) ≥ 1500/μL, platelets ≥10^5/μL, hemoglobin level >9.0 g/dL
  • liver function: total bilirubin ≤1.5 x ULN, AST / ALT ≤3.0 x ULN
  • Cooperation and willingness to complete all aspects of the study
  • Written informed consent to participate in the study
  • Patients ≥ 70 years of age.
  • Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
  • No prior chemotherapy (except fluoruracil or gemcitabine in an adjuvant setting at least > 6 months prior enrollment).
  • Cooperation and willingness to complete all aspects of the study
  • Written informed consent to participate in the study

Who cannot join

  • Patients <70 years of age.
  • Papillary cancer, cholangiocellular carcinoma, neuro-endocrine tumors.
  • Patient has a severe and/or uncontrolled medical disease (i.e. uncontrolled active infection, uncontrolled hypertension/ diabetes or cardiac disease).
  • Patient has received any other investigational product within 28 days prior study entry.
  • Patient is < 5 years free of another primary malignancy (except: not currently clinically significant nor requiring active intervention)
  • Hypersensitivity against gemcitabine or nab-paclitaxel.
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  • Major surgery ≤ 28 days prior to study entry.
  • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  • Any other chemotherapy at start.
  • Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial.
  • Parallel participation in another clinical trial or participation in another clinical trial within the last 30 days or 7 half-lifes of a study medication, whichever is of longer duration, prior study start.
  • Patient has already been recruited in this trial.
  • Patients who do not understand the nature, the scope and the consequences of the clinical trial.
  • Patient who might be dependent on the sponsor, the study site or the investigator.
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 Nr. 4 AMG.
  • Patients <70 years of age.
  • Papillary cancer, cholangiocellular carcinoma, neuro-endocrine tumors.
  • Patient has received any other investigational product within 28 days prior study entry.
  • Patient is < 5 years free of another primary malignancy (except: not currently clinically significant nor requiring active intervention)
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  • Any chemotherapy at study start.
  • Any psychiatric illness that would affect the patient's ability to understand the demands of the clinical trial.
  • Parallel participation in another clinical trial or participation in another clinical trial within the last 30 days or 7 half-lifes of a study medication, whichever is of longer duration, prior study start.
  • Patient has already been recruited in this trial.
  • Patients who do not understand the nature, the scope and the consequences of the clinical trial.
  • Patient who might be dependent on the sponsor, the study site or the investigator.
  • Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 Nr. 4 AMG.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsklinikum Mannheim II. Medizinische Klinik

    Mannheim, 68167

Other trials in Germany

About this study

Official title: A Multicenter Phase 4 Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients

The GrantPax study is a multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/- nab-paclitaxel in elderly pancreatic cancer patients. The primary objective is that CGA-stratified patients do not decline in their CGA performance in response to chemotherapy measured as a loss of five points or less in the Barthel's ADL, (ADL1 vs. ADL2 during core CGA assessment).

Read the detailed description

The hypothesis of the proposed study is that individualized assessment directed treatment algorithms identifies elderly patients, who benefit from combined nab-paclitaxel/gemcitabine therapy. The project uses a CGA, which includes various tests and scoring systems, to stratify patients as "GO-GO", "SLOW-GO" or "FRAIL" patients. Depending on test results patients receive chemotherapy (GO-GO group: nab-paclitaxel/gemcitabine; SLOW-GO group: gemcitabine monotherapy) or best supportive care (FRAIL group). After the first cycle of chemotherapy (4 weeks) a subsequent CGA and a safety assessment will be performed to assign patients to their definite treatment arm. The primary objective is that CGA-stratified patients do not decline in their CGA performance in response to chemotherapy measured as a loss of five points or less in the Barthel's ADL (ADL1 vs. ADL2 during core CGA assessment).

Being tested
Nab-paclitaxel, Gemcitabine, Best Supportive Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02812992
Study groupRoleWhat they receive
GO-GO armActive comparatorNab-paclitaxel 125 mg/m^2 i.v. over 30 minutes followed by gemcitabine infusion 1000 mg/m^2 on days D1, D8, D15 of a 28-day cycle.
Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine
SLOW-GO armActive comparatorGemcitabine 1000 mg/m^2 i.v. on days D1, D8, D15 of a 28-day cycle.
Receives: Drug: Gemcitabine
FRAIL armActive comparatorBest supportive care as determined by the investigator.
Receives: Other: Best Supportive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Barthel's ADL [Barthel's scale in activities of daily living]

    Loss of five points or less in the Activity of Daily Living (Barthel's ADL; assessed during 2nd CGA) after first cycle of chemotherapy (or after 4 weeks in BSC group) compared to the initial ADL for each treatment groups.

    Measured: 4 weeks

Secondary outcomes (18)

  1. CGA [Comprehensive Geriatric Assessment]

    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC

    Measured: 4 weeks

  2. ECOG [Eastern Cooperative Oncology Group]

    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC

    Measured: 4 weeks

  3. ADL (Barthel) [Activities of Daily Living]

    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC

    Measured: 4 weeks

  4. IADL (Lawton/Browdy) [Instrumental Activities of Daily Living]

    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC

    Measured: 4 weeks

  5. G8-Questionnaire

    Scores before and after 1st treatment cycle (CGA1+2 further CGA scores 3+4 - if available) or after 28 days of BSC

    Measured: 4 weeks

  6. CR [Complete Response]

    Measured: 12 months

  7. PR [Partial Response]

    Measured: 12 months

  8. DCR [Disease Control Rate]

    Measured: 12 months

  9. ORR [Objective Response Rate]

    Measured: 12 months

  10. AEs/SAEs [Adverse Events/Serious Adverse Events]

    Measured: 12 months

  11. PFS [Progression Free Survival]

    Measured: 12 months

  12. OS [Overall Survival]

    Measured: 12 months

  13. Percentage of patients receiving at least one chemotherapy in each treatment group

    Measured: 12 months

  14. Percentage of patients escalating treatment

    Measured: 12 months

  15. Duration of treatment

    Measured: 12 months

  16. Cumulative dose

    Measured: 12 months

  17. QoL [Quality of Life]

    time to QoL deterioration [loss of 10 points or more in QLQ-C30]

    Measured: 12 months

  18. Discrepancy between CGA strata estimation by the investigator and true CGA assessment

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionFeb 2020
  4. Study completionFeb 2021

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02812992
Sponsor's protocol ID
AIO-GER-0115
Acronym
GrantPax
Status last verified
Aug 2021
First submitted
7 Jun 2016
Last updated
10 Aug 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Betge J, Chi-Kern J, Schulte N, Belle S, Gutting T, Burgermeister E, Jesenofsky R, Maenz M, Wedding U, Ebert MP, Haertel N. A multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/- nab-paclitaxel in elderly pancreatic cancer patients (GrantPax). BMC Cancer. 2018 Jul 18;18(1):747. doi: 10.1186/s12885-018-4665-2.

    PubMed 30021548

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nab-paclitaxel and Gemcitabine in people with Adenocarcinoma 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 28 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 10 Aug 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Barthel's ADL [Barthel's scale in activities of daily living] (time frame: 4 weeks). 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 NCT02812992, 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 10 Aug 2021.

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