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A Phase 1b/2 Study of Abemaciclib Plus Chemotherapy and/or Chemoimmunotherapy in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors
EU CTIS ID: 2023-506778-11-00
What this study is testing
To determine the optimal RP2D for abemaciclib in patients with relapsed/refractory solid tumors: - in combination with irinotecan and temozolomide (Part A) - in combination with temozolomide (Part B)
- Phase I and Phase II (Integrated)- Other
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
- Parts A and B only: Participants must be less than or equal to (≤)18 years of age. Body weight greater than or equal to (≥)10 kilograms and body surface area (BSA) ≥0.5 Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies. For sites that are actively enrolling Parts B and C, participants with neuroblastoma who are eligible for Part C will be excluded from Part B unless approved by Lilly CRP/CRS.
- Part C only: Participants must be less than (<) 21 years of age. Participants have a BSA ≥0.2 m². Participants with first relapse/refractory neuroblastoma.
- All Parts Participants must have measurable or evaluable disease by RECIST v1.1 or RANO. A Lansky score ≥50 for participants <16 years of age or Karnofsky score ≥50 for participants ≥16 years of age. Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment. Able to swallow and/or have a gastric/nasogastric tube. Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug. Females of reproductive potential must have negative urine or serum pregnancy test at baseline (within 7 days prior to starting treatment). Female participants of reproductive potential must agree to use highly effective contraceptive precautions during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib. For other study drugs, highly effective contraceptive precautions (and avoiding sperm donation) must be used according to their label. Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment. Caregivers and participants willing to make themselves available for the duration of the trial.
You likely can't join if
- Received allogenic bone marrow or solid organ transplant.
- Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor
- Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma.
- Part C only, have received prior anti-GD2 therapy during induction phase.
- Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device.
- Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
See the full eligibility criteria
Who can join
- Parts A and B only: Participants must be less than or equal to (≤)18 years of age. Body weight greater than or equal to (≥)10 kilograms and body surface area (BSA) ≥0.5 Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies. For sites that are actively enrolling Parts B and C, participants with neuroblastoma who are eligible for Part C will be excluded from Part B unless approved by Lilly CRP/CRS.
- Part C only: Participants must be less than (<) 21 years of age. Participants have a BSA ≥0.2 m². Participants with first relapse/refractory neuroblastoma.
- All Parts Participants must have measurable or evaluable disease by RECIST v1.1 or RANO. A Lansky score ≥50 for participants <16 years of age or Karnofsky score ≥50 for participants ≥16 years of age. Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment. Able to swallow and/or have a gastric/nasogastric tube. Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug. Females of reproductive potential must have negative urine or serum pregnancy test at baseline (within 7 days prior to starting treatment). Female participants of reproductive potential must agree to use highly effective contraceptive precautions during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib. For other study drugs, highly effective contraceptive precautions (and avoiding sperm donation) must be used according to their label. Life expectancy of at least 8 weeks and able to complete at least 1 cycle of treatment. Caregivers and participants willing to make themselves available for the duration of the trial.
What rules you out
- Received allogenic bone marrow or solid organ transplant.
- Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor
- Part C only: Received prior systemic therapy for relapsed/refractory neuroblastoma.
- Part C only, have received prior anti-GD2 therapy during induction phase.
- Currently enrolled in any other clinical study involving an investigational product or non-approved use of a drug or device.
- Has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
- Received live vaccination.
- Intolerability or hypersensitivity to any of the study treatments or its components.
- Diagnosed and/or treated additional malignancy within 3 years prior to enrollment that may affect the interpretation of results, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers.
- Pregnant or breastfeeding.
- Active systemic infections.
- Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study.
- Parts A and C only: Have a bowel obstruction.
- Prior treatment with drugs known to be strong inhibitors or inducers of isoenzyme cytochrome P450 3A (CYP3A) or strong inhibitors of uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) if the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- 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; 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.