An Extension Study of trastuzumab emtansine administered as a single agent or in combination with other anti-cancer therapies in patients previously enrolledin a Genentech and /or F. Hoffmann-La Roche Ltd. – sponsored trastuzumab emtansine 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

17 Jun 2011 → ongoing

Decision date (initial)

2024-03-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

F. Hoffmann-La Roche AG

External identifiers

EU CT number

2023-503479-79-00

EudraCT number

2010-021067-32

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

- To provide trastuzumab emtansine therapy as single agent or in combination with other agents to HER2-positive metastatic cancer patients who derived benefit from therapy administered in the Roche-sponsored trastuzumab emtansine parent study. - To provide continued study treatment to patients in the control arm of study BO21976/TDM4450g who derived benefit from the treatment administered during the study. - To collect safety data with regard to long-term administration of single agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other agents.

Secondary objectives 1

1. Not Applicable (N/A)

Conditions and MedDRA coding

Metastatic Cancer

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study or continue to receive treatment in the control arm of study BO21976/TDM4450g at the time of the study closure
2. Adequate organ function, evidenced by the following laboratory results within 7 days of the first study drug infusion for this study: Absolute neutrophil count > 1000 cells/mm3 Platelet count > 75,000 cells/mm3 Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) SGOT (AST) and SGPT (ALT) ≤ 5 x the ULN Creatinine < 1.8 x the ULN
3. Expectation by the investigator that the patient may continue to benefit from additional study treatment.
4. LVEF ≥ 40% at baseline within 30 days prior to study entry as determined by either ECHO or MUGA Patients with an LVEF ≥ 40%-45% must have had an absolute change of <10% from baseline (using as reference the baseline LVEF from the parent study prior to the start of study therapy).
5. ECOG Performance Status of 0-2
6. For women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner during the treatment period and for at least 5 months after the final dose of atezolizumab (if applicable) or 7 months after the final dose of trastuzumab, trastuzumab emtansine or pertuzumab, whichever is later. Women must refrain from donating eggs during this same period. For men, agreement to use an effective form of contraception and to continue its use for the duration of the study. Men must refrain from donating sperm during this same period.

Exclusion criteria 6

1. Adverse events leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study.
2. Ongoing serious adverse events from the parent study
3. Progressive disease (except for isolated CNS progression) on single agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study.
4. Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version (V) 3.0, V4.0 or V5.0, as utilized in the parent study.
5. History of symptomatic congestive heart failure ([CHF]; New York Heart Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, or history of myocardial infarction within 6 months prior to study entry.
6. History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the patient’s last study drug dose in the parent study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1. Incidence of adverse events leading to trastuzumab emtansine or combination treatment discontinuation or dose reduction.
2. 2. Incidence of all adverse events and all serious adverse events

Secondary endpoints 1

1. N/A

Investigational products

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

Test 3

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 2

Locations

5 EU/EEA countries · 9 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 22 files

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

Application history

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