An open-label extension study of pertuzumab administered on its own or in combination with other anti-cancer therapies in patients previously enrolled in a Hoffmann-La Roche sponsored pertuzumab study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

18 Dec 2014 → ongoing

Decision date (initial)

2024-06-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

External identifiers

EU CT number

2023-505102-42-00

EudraCT number

2014-002048-42

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To provide continued pertuzumab therapy to patients who were previously enrolled in a F. Hoffmann-La Roche (Roche)-sponsored pertuzumab study (the Parent study) and who continue to derive benefit from pertuzumab-based therapy administered in the Parent study at the time of Parent study closure.

Secondary objectives 1

1. To collect long-term safety and efficacy data of pertuzumab therapy.

Conditions and MedDRA coding

Solid Malignant Tumors

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Signed written Informed consent approved by the relevant Ethics Committee (EC) or the Institutional Review Board (IRB)
2. Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure
3. Investigator's opinion that the patient continues to benefit from pertuzumab treatment

Exclusion criteria 6

1. Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study
2. Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study
3. Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion 5 below.
4. More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study
5. Left ventricular ejection fraction ≤ 50%
6. Positive serum pregnancy test in women of childbearing potential (WOCBP) defined as pre-menopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. AEs, serious adverse events (SAEs), AEs leading to pertuzumab discontinuation or dose interruption, and non-serious AEs of special interest (AESIs) Adverse events will be classified according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]

Secondary endpoints 2

1. 1. Assessments of Progression free survival (PFS) will be done per Investigator’s assessment, based on local institution’s standard of care
2. 2. Overall Survival (OS)

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 4

Locations

3 EU/EEA countries · 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 14 files

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

Application history

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