A Multi-Center Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors with Rearranged During Transfection (RET) Activation (LIBRETTO-201)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eli Lilly & Co.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

24 Oct 2019 → ongoing

Decision date (initial)

2024-07-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-507678-42-00

EudraCT number

2019-002319-25

WHO UTN

U1111-1302-4698

ClinicalTrials.gov

NCT03906331

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To provide access to selpercatinib for patients with locally advanced or metastatic solid tumors with activating RET alterations who are 18 years of age or older

Conditions and MedDRA coding

Non Small Cell Lung Cancer; Medullary Thyroid Cancer; Colon Cancer; Breast Cancer; Pancreatic Cancer; Papillary Thyroid Cancer; Other Solid Tumors With Evidence of Activating RET Alteration;

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient is diagnosed with a locally advanced or metastatic tumor with evidence of qualifying/activating RET gene alteration who: - is not eligible for an ongoing selpercatinib clinical trial (for example, for clinical, geographic or financial reasons or due to cohort closure), but are deemed appropriate candidates to receive selpercatinib treatment by the treating physician and the Sponsor, and - Has progressed on, are intolerant to standard therapy, or no standard therapy exists -For regions where drug has become regulatory approved, local labeling language should be followed
2. Eighteen years of age or older at the time of consent.
3. Adequate hematologic, renal and hepatic function as defined in Section 5.1.
4. Ability to provide consent by patient or legally authorized representative.
5. Provision of a signed informed consent prior to any protocol specific procedures.
6. Willingness of men and women of childbearing potential to observe double effective birth control methods, defined as one used by the patient and another by his/her partner, for the duration of treatment and for 3 months following the last dose of treatment.

Exclusion criteria 3

1. Major surgery within 14 days prior to C1D1
2. Investigational agent (via clinical trial) or anticancer therapy within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of selpercatinib unless considered by the treating physician to be safe, within the best interest of the patient and with prior Sponsor approval.
3. Have clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of treatment or prolongation of the QT interval corrected for heart rate using 􀀛􀀽􀀴􀀯􀀰􀀽􀀴􀀮􀀴􀀬􀁌􀀾􀀁􀀱􀀺􀀽􀀸􀁀􀀷􀀬􀀁􀀂􀀥􀀨􀀮􀀛􀀃􀀁􀀕􀀌􀀏􀀈􀀁􀀸􀀾ec on more than 1 ECG obtained during the baseline period. Note: Patients who meet this criteria may be enrolled (with a modified dosing strategy) if a clinical rationale exists which is reviewed and agreed upon by the Sponsor. Patients with implanted pacemakers may enter the program without meeting corrected QT interval (QTc) criteria due to non-evaluable measurement.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. There are no endpoints or data analysis for this EAP trial.

Secondary endpoints 1

1. There are no endpoints or data analysis for this EAP trial.

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

Sponsor organisation

Eli Lilly & Co.

Address

1 Lilly Corporate Center

City

Indianapolis

Postcode

46285-0001

Country

United States

Scientific contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Public contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Third parties 2

Locations

4 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 29 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