A lower dose olaparib, combined with a drug which inhibits olaparib degradation, to increase tolerability and decrease the price of the treatment with olaparib

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Radboud universitair medisch centrum

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

1 Oct 2024 → ongoing

Decision date (initial)

2024-10-01

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516414-38-00

EudraCT number

2021-004032-28

ClinicalTrials.gov

NCT05078671

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

Part A – proof-of-concept:
1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.
Part B – clinical evaluation:
1. To determine if tolerance by dose reductions due to toxicity in patients treated with the lower equivalent boosted dose of olaparib is non-inferior to patients treated with the regular dose of olaparib.

Conditions and MedDRA coding

Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Part A: Subjects who start or are on treatment with olaparib tablets, according to the drug label and physician’s discretion.
2. Part A+B: Subjects who are able and willing to provide written informed consent prior to screening;
3. Part A: Able to measure the outcome of the study in this subject (e.g. patient availability; willing and being able to undergo repeated plasma sample collection).
4. Part A+B: Age of 18 years or older.
5. Part A: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Part B: Subjects who start on treatment with olaparib tablets, according to the drug label and physician’s discretion.
7. Part B: Able to measure the outcome of the study in this subject (e.g. patient availability; willing and being able to undergo sample collection for PK and PD purposes).
8. Part B: Expected to be on olaparib treatment for ≥ 3 months.
9. Part B: Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.

Exclusion criteria 3

1. Part A+B: Concurrent use of other anti-cancer therapies.
2. Part A+B: Concurrent use of potent inducers or inhibitors of CYP3A4 as assessed with the KNMP “G-standaard”.
3. Part A+B: Known contra-indications for treatment with cobicistat in line with the summary of product characteristics.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part A: AUC0-12h for the regular and boosted olaparib will be determined using noncompartmental analysis for the primary objective. Hereto, multiple PK samples will be collected after one week of each treatment regimen at the following times: pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8 hours after olaparib intake. If possible, additional PK samples will be taken after 10 and 12 hours.
2. Part B: The number of patients who require a dose reduction due to toxicity will be registered.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud universitair medisch centrum

Sponsor organisation

Stichting Radboud universitair medisch centrum

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Stichting Radboud universitair medisch centrum

Contact name

Joanneke Overbeek

Public contact point

Organisation

Stichting Radboud universitair medisch centrum

Contact name

Joanneke Overbeek

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 20 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