Study to compare overall survival (OS) between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Panbela Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 Nov 2022 → 28 Mar 2025

Decision date (initial)

2024-11-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Panbela Therapeutics, Inc, United States

External identifiers

EU CT number

2024-514714-12-00

EudraCT number

2021-005790-60

ClinicalTrials.gov

NCT05254171

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective of the study is to compare overall survival (OS) between subjects who receive SBP-101 and those who do not receive SBP-101 (i.e., placebo) in combination with nab-paclitaxel and gemcitabine.

Secondary objectives 1

1. The secondary objective is to compare progression free survival (PFS) between SBP-101 and placebo. Other Secondary Efficacy: To compare objective response rate (ORR) between SBP-101 and placebo To compare disease control rate (DCR) between SBP-101 and placebo To compare duration of response (DoR) between SBP-101 and placebo To compare changes in quality of life (QOL) scores between SBP-101 and placebo To compare the safety and tolerability of SBP-101 compared to placebo when administered in combination with nab-paclitaxel and gemcitabine. Exploratory: To compare the effects of SBP-101 and placebo on blood levels of CA19-9 and circulating tumor DNA (cT DNA).

Conditions and MedDRA coding

Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. 2. Is previously untreated for metastatic pancreatic ductal adenocarcinoma; metastatic disease must have been diagnosed within the past 3 months; and subject is expected to receive standard treatment with gemcitabine and nab-paclitaxel. 3. Life expectancy ≥3 months. 6. Adult, age ≥ 18 years, male or female. 7. Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception. Male subjects with partners who are oCBP should also use a highly effective contraceptive measure during the study and through 6 months following the last administration of study drug. 8. Adequate bone marrow, hepatic, renal, and coagulation function 9. QTc interval of ≤ 470 msec ms (for women) and ≤ 450 ms (for men) on the ECG baseline calculated by either the Fridericia or Framingham formula. 10. Willing and able to provide written informed consent

Exclusion criteria 1

1. 1.Subjects known to have mutations of the BRCA1/2 (Breast Cancer gene). 2. Concomitant metformin administration. 3. - 13., 18. History of noncompliance or any previous or concomitant disease, condition and/or medication that might compromise the subject's ability to give informed consent, make it undesirable for the subject to participate in the study, would jeopardize the participant's safety or compliance with the protocol or might interfere with the reliability of the data collected. 14. Pregnant or lactating. 15. Major surgery within 4 weeks of the start of study treatment, without complete recovery. 16. Known hypersensitivity to any component of study drug treatments. 17. Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug. Participation in observational trials is not excluded.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. OS defined as the time (days) from Study Day 1 (the date of first dose of study drug treatment) until death from any cause.

Secondary endpoints 1

1. PFS defined as time until disease progression or death from any cause, whichever occurs first. ORR defined as percentage of subjects with a best overall response of CR or PR, determined using RECIST 1.1 criteria. DCR defined as percentage of subjects with confirmed CR, PR, or SD for at least 16 weeks. DoR in subjects who achieve a CR or PR, defined as time from onset of first CR or PR until disease progression or death from any cause. QoL, assessed using EORTC QLQ-30 and QLQ-PAN26 questionnaires

Investigational products

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

Test 1

Placebo 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Panbela Therapeutics Inc.

Sponsor organisation

Panbela Therapeutics Inc.

Address

712 Vista Boulevard 305

City

Waconia

Postcode

55387-4559

Country

United States

Scientific contact point

Organisation

Panbela Therapeutics Inc.

Contact name

Scientific contact point

Public contact point

Organisation

Panbela Therapeutics Inc.

Contact name

Public contact point

Third parties 6

Locations

6 EU/EEA countries · 62 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 18 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