Timing of start of systemlc treatment for asymptomatic MEtastasized PANcreatic cancer (TIMEPAN): a prospective multicenter patient preference cohort

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

28 Oct 2024 → ongoing

Decision date (initial)

2024-10-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-509465-20-00

EudraCT number

2019-004582-40

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the effect of immediate versus delayed start of chemotherapy on quality adjusted overall survival in patients with metastatic pancreatic cancer.

Secondary objectives 6

1. To determine time to disease progression after inclusion (Restricted mean progression free survival (RM-PFS): area under the Kaplan-Meier PFS curve between inclusion and maximum follow-up of the study, estimated 12 months)
2. To determine Quality adjusted Progression Free Survival (PFS)
3. To determine Overall survival (in months)
4. To determine duration of time without symptoms of disease progression or toxicities (TWiST)
5. To determine the adverse events according to NCI CTC version 5.0
6. To determine change in CA 19.9

Conditions and MedDRA coding

metastatic pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF).
2. Patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma.
3. Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria.
4. Eastern Cooperative Oncology Group Performance Status of 0-1
5. Life expectancy ≥ 3 months.
6. Age ≥ 18 years
7. A negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication) if female subject is of childbearing potential.
8. Screening clinical laboratory values as follows: a. Absolute neutrophil count > 1.5 x 109 /L b. Total bilirubin ≤ 1.5 times upper limit of normal (ULN). c. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN, (if liver metastases are present, then ≤ 5 times ULN is allowed). d. Serum creatinine < 1.5 x ULN or creatinine clearance >50 mL/min/1.73 m2 e. Prothrombin time/international normalized ratio within normal limits (± 15%) or within therapeutic range if subject takes warfarin. Partial thromboplastin time (PTT) within normal limits (± 15%). f. Platelet count > 100,000 x 109 /L
9. No symptoms related to advanced disease, specified as: a. no pain requiring regular narcotic analgesics; b. no weight loss over 5 kg (unless related to surgery or other illness); c. no persistent nausea requiring medication; d. no obstructive bowel symptoms; e. no persistent fever related to metastatic cancer; f. no other symptom which in the opinion of the clinician was due to progressive metastatic cancer.
10. No prior chemotherapy for metastatic disease (patients might have received adjuvant treatment more than 6 months before the development of metastatic disease, or neoadjuvant treatment before surgery for resectable disease)

Exclusion criteria 5

1. Known central nervous system involvement or brain metastases.
2. New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months
3. Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications.
4. Inability to comply with study and follow-up procedures as judged by the Investigator.
5. Women currently pregnant or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Quality Adjusted Overall Survival

Secondary endpoints 6

1. Time to disease progression after inclusion (Restricted mean progression free survival (RM-PFS): area under the Kaplan-Meier PFS curve between inclusion and maximum follow-up of the study, estimated 12 months)
2. Quality adjusted Progression Free Survival (PFS)
3. Overall survival (in months)
4. Duration of time without symptoms of disease progression or toxicities (TWiST)
5. Adverse events according to NCI CTC version 5.0
6. Change in CA 19.9

Investigational products

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

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

Marc Zuurbier

Public contact point

Organisation

Amsterdam UMC

Contact name

Marc Zuurbier

Locations

1 EU/EEA country · 14 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 8 files

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

Application history

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