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A Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Ewing's Sarcoma
EU CTIS ID: 2023-506772-28-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of Ewing's sarcoma or Ewing's sarcoma-like tumor
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to Cycle 1 Day 1.
- 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
- Participants aged 1 to <40 years
- Body weight ≥10 kg
- 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
You likely can't join if
- 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
- Diagnosed and/or treated additional malignancy within 3 years prior to enrollment
- 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.
- Participants who have had allogeneic bone marrow or solid organ transplant
- 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
- Surgical or other wounds must be adequately healed prior to enrollment
See the full eligibility criteria
- Diagnosis of Ewing's sarcoma or Ewing's sarcoma-like tumor
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to Cycle 1 Day 1.
- 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
- Participants aged 1 to <40 years
- Body weight ≥10 kg
- 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
- The participant has adequate hematologic and organ function ≤14 days prior to Day 1 of Cycle 1
- Must be able to swallow and/or have a gastric/nasogastric tube.
- Participants in the European Union must be able to swallow intact capsules.
- Discontinued all previous treatments for cancer or investigational agents and recovered from the acute effects to Grade ≤1 at the time of enrollment
- 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
- Diagnosed and/or treated additional malignancy within 3 years prior to enrollment
- 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.
- Participants who have had allogeneic bone marrow or solid organ transplant
- 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
- Surgical or other wounds must be adequately healed prior to enrollment
- Female participants who are pregnant or breastfeeding
- Have received any prior cyclin-dependent kinase (CDK) 4 and 6 inhibitor
- Progression during prior treatment with irinotecan and/or temozolomide
- Have a known intolerability or hypersensitivity to any of the study treatments or dacarbazine
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.