A randomized phase II study of gemcitabine versus reduced-dose combination chemotherapy in fragile patients with non-resectable pancreatic cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aalborg University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

20 Oct 2023 → ongoing

Decision date (initial)

2024-09-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514291-41-00

EudraCT number

2021-005067-52

ClinicalTrials.gov

NCT05841420

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The aim of this study is to evaluate if standard dose Gem or reduced dose of GemNab is the best treatment for non-resectable PC patients unfit or not candidate for full dose combination chemotherapy in first line.

Conditions and MedDRA coding

Pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Age ≥ 18 years
2. Adenocarcinoma of the pancreas, histopathologically or cytologically verified
3. Non-resectable (locally advanced or metastatic) PC o Locally advanced is defined as both 1) pancreatic cancer confined to the pancreas with direct infiltration of nearby vessels with or without regional lymph node metastases and 2) inoperable (medically or technically) local recurrence of pancreatic cancer with or without regional lymph node metastases. Furthermore, metastatic disease includes peritoneal metastatic disease.
4. Patients unfit or not candidate for full-dose combination chemotherapy
5. Patients eligible for full dose gemcitabine or reduced dose combination chemotherapy
6. Performance status (PS) ≤ 2
7. Measurable or non-measurable disease
8. Adequate hematologic function defined as absolute neutrophil count (ANC) ≥ 1.5x109/l and platelets count ≥ 100x109/l within 2 weeks prior to enrollment
9. Adequate organ function (bilirubin ≤ 1.5 x UNL (Upper normal limit) and eGFR > 30ml/min within 2 weeks prior to enrollment
10. Toxicity of prior chemotherapy, including neurotoxicity, resolved to CTCAE < grade 2
11. Oral and written informed consent must be obtained according to the local Ethics committee requirements
12. Fertile patients must use adequate contraceptives

Exclusion criteria 8

1. Patients eligible for downstaging/preoperative chemotherapy followed by resection or local ablation or irradiation
2. Prior chemotherapy for PC (however, patients treated with adjuvant therapy with recurrence occurring more than 6 months after end of this treatment are eligible)
3. Concurrent, non-curatively treated malignant neoplasm other than pancreatic adenocarcinoma
4. Concurrent treatment with any other anti-cancer therapy
5. Pregnant or breast-feeding patients
6. Patients clearly intending to withdraw from the study if not randomized in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar, or geographic reasons.
7. Other condition or therapy, which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.
8. Known allergy or intolerance to any of the drugs used in DPCG-01 (gemcitabine or nab-paclixatel)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression Free Survival (PFS)

Secondary endpoints 5

1. Overall Survival (OS)
2. Response rate
3. Number of hospitalizations during treatment
4. Quality of life assessed by EORTC QLQ-C30 at baseline and after 8, 16, and 24weeks
5. Cumulative worst toxicity during treatment (Adverse events ≥ grade 3 according to CTCAE version 5.0)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aalborg University Hospital

Sponsor organisation

Aalborg University Hospital

Address

Hobrovej 18-22

City

Aalborg

Postcode

9000

Country

Denmark

Scientific contact point

Organisation

Aalborg University Hospital

Contact name

Department of Oncology

Public contact point

Organisation

Aalborg University Hospital

Contact name

Department of Oncology

Third parties 2

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications