A Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Ewing's Sarcoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eli Lilly & Co.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

7 Oct 2022 → 19 Jul 2025

Decision date (initial)

2024-03-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2023-506772-28-00

EudraCT number

2021-004734-11

WHO UTN

U1111-1302-8098

ClinicalTrials.gov

NCT05440786

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety, Pharmacokinetic

The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolamide) for Ewing's sarcoma that has come back or did not respond to treatment.

Conditions and MedDRA coding

Ewings Sarcoma

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002342-PIP01-18

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Diagnosis of Ewing's sarcoma or Ewing's sarcoma-like tumor
2. Confirmed radiological progression or refractory disease or recurrence following first or later line of treatment of Ewing's sarcoma or Ewing's sarcoma-like tumor, and must have one measurable or evaluable lesion per RECIST 1.1
3. Participants aged 1 to <40 years
4. Body weight ≥10 kg
5. Adequate performance status based on age. For participants <16 years of age, a Lansky score ≥50, or for participants ≥16 years of age, a Karnofsky score ≥50
6. The participant has adequate hematologic and organ function ≤14 days prior to Day 1 of Cycle 1
7. Must be able to swallow and/or have a gastric/nasogastric tube.
8. Participants in the European Union must be able to swallow intact capsules.
9. Discontinued all previous treatments for cancer or investigational agents and recovered from the acute effects to Grade ≤1 at the time of enrollment
10. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to Cycle 1 Day 1.

Exclusion criteria 10

1. Participants with severe and/or uncontrolled concurrent medical disease or psychiatric illness/social situation that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
2. Participants with an active fungal, bacterial, and/or known severe viral infection including, but not limited to, human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis.
3. Participants who have had allogeneic bone marrow or solid organ transplant
4. Surgery: Participants who have had, or are planning to have, the following invasive procedures: Major surgical procedure, laparoscopic procedure, or significant traumatic injury within 28 days prior to enrollment
5. Surgical or other wounds must be adequately healed prior to enrollment
6. Female participants who are pregnant or breastfeeding
7. Have received any prior cyclin-dependent kinase (CDK) 4 and 6 inhibitor
8. Progression during prior treatment with irinotecan and/or temozolomide
9. Have a known intolerability or hypersensitivity to any of the study treatments or dacarbazine
10. Diagnosed and/or treated additional malignancy within 3 years prior to enrollment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression Free Survival as determined by blinded independent review committee using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)

Investigational products

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

Test 3

Comparator 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 10

Locations

4 EU/EEA countries · 19 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 61 files

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

Application history

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