A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors
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ClinicalTrials.gov Identifier: NCT04238819 |
Recruitment Status :
Recruiting
First Posted : January 23, 2020
Last Update Posted : April 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsed Solid Tumor Refractory Solid Tumor | Drug: Abemaciclib Drug: Irinotecan Drug: Temozolomide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b Dose Escalation Study of Abemaciclib in Combination With Temozolomide and Irinotecan (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors |
Actual Study Start Date : | November 9, 2020 |
Estimated Primary Completion Date : | May 5, 2022 |
Estimated Study Completion Date : | January 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose Escalation: Abemaciclib + Irinotecan + Temozolomide
Abemaciclib given orally, irinotecan given intravenously (IV) and temozolomide given orally.
|
Drug: Abemaciclib
Administered orally
Other Name: LY2835219 Drug: Irinotecan Administered IV Drug: Temozolomide Administered orally |
Experimental: Dose Expansion: Abemaciclib + Irinotecan + Temozolomide
Abemaciclib given orally, irinotecan given IV and temozolomide given orally.
|
Drug: Abemaciclib
Administered orally
Other Name: LY2835219 Drug: Irinotecan Administered IV Drug: Temozolomide Administered orally |
Experimental: Dose Escalation: Abemaciclib + Temozolomide
Abemaciclib and temozolomide given orally.
|
Drug: Abemaciclib
Administered orally
Other Name: LY2835219 Drug: Temozolomide Administered orally |
Experimental: Dose Expansion: Abemaciclib + Temozolomide
Abemaciclib and temozolomide given orally.
|
Drug: Abemaciclib
Administered orally
Other Name: LY2835219 Drug: Temozolomide Administered orally |
- Number or Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (21 Day Cycle) ]Number of Participants with DLTs
- Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib [ Time Frame: Cycle 1 through Cycle 3 (21 Day Cycle) ]PK: Mean Steady State Concentrations of Abemaciclib
- PK: Mean Steady State Concentrations of Irinotecan [ Time Frame: Cycle 1 through Cycle 3 (21 Day Cycle) ]PK: Mean Steady State Concentrations of Irinotecan
- PK: Mean Steady State Concentrations of Temozolomide [ Time Frame: Cycle 1 through Cycle 3 (21 Day Cycle) ]PK: Mean Steady State Concentrations of Temozolomide
- Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Disease Progression or Death (Estimated up to 24 Months) ]ORR: Percentage of Participants with Best Response of CR or PR
- Duration of Response (DoR) [ Time Frame: Date of First Evidence of a CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 24 Months) ]DoR
- Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR or SD With a Duration of At Least 6 Months [ Time Frame: Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 24 Months) ]CBR: Percentage of Participants With Best Overall Response of CR, PR or SD With a Duration of At Least 6 Months
- Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease (SD) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 24 Months) ]DCR: Percentage of Participants with a Best Overall Response of CR, PR, and SD
- Acceptability Questionnaire [ Time Frame: Cycle 2 Day 1 (21 Day Cycles) ]Participants were evaluated for abemaciclib acceptability (palatability and ease of administration) using a 5-category questionnaire. Participants were asked to answer one of the following to describe the acceptability of abemaciclib: Very difficult, difficult, neither easy nor difficult, easy, or very easy.

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Body weight ≥10 kilograms and body surface area (BSA) ≥0.5 meters squared.
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Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies and, in the judgment of the investigator, are appropriate candidates for the experimental therapy combination in the study part that is currently enrolling.
- Participants must have at least one measurable (per Response Criteria in Solid Tumors [RECIST v1.1; [Eisenhauer et al. 2009] or Response Assessment in Neuro-Oncology (RANO) for central nervous system (CNS) tumors [Wen et al. 2010]) or evaluable lesion.
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Participants must have had histologic verification of malignancy at original diagnosis or relapse, except:
- Participants with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta- human chorionic gonadotropin (HCG).
- Participants with intrinsic brain stem tumors or participants with CNS-germ cell tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG.
- 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.
- Adequate hematologic and organ function ≤2 weeks (14 days) prior to first dose of study drug.
- Females of reproductive potential must have negative serum pregnancy test at baseline (within 7 days prior to starting treatment).
- Both female and male participants of reproductive potential must agree to use highly effective contraceptive precautions (and avoid sperm donation for males) during the trial. For abemaciclib, females should use contraception for at least 3 weeks following the last abemaciclib dose (males have no restriction for contraceptive use following treatment with 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.
Exclusion Criteria:
- Received allogenic bone marrow or solid organ transplant.
- Received live vaccination (within 4 weeks prior to starting study treatment).
- Have a personal history of any of the following conditions within the last 12 months: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
- 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 or viral load.
- Serious and/or uncontrolled preexisting medical condition(s) that would preclude participation in this study.
- Have a bowel obstruction (Part A of this study only).
- Treated 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.
- Received prior treatment with cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
- 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.
- Tumor contains known somatic or germline retinoblastoma (RB) mutation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238819
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | Clinicaltrials.gov@lilly.com |
United States, Arizona | |
Phoenix Childrens Hospital | Not yet recruiting |
Phoenix, Arizona, United States, 85016 | |
Contact 602-406-2141 | |
Principal Investigator: Lindsey M Hoffman | |
United States, Minnesota | |
University of Minnesota Hospital | Not yet recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact 612-626-3593 | |
Principal Investigator: Emily Greengard | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact 267-426-5414 | |
Principal Investigator: Frank M Balis | |
Belgium | |
UZ-Gent | Recruiting |
Gent, Belgium, 9000 | |
Contact 003293324812 | |
Principal Investigator: Bram De Wilde | |
France | |
Centre Leon Berard | Recruiting |
Lyon CEDEX 08, Rhône-Alpes, France, 69373 | |
Contact 0033469166550 | |
Principal Investigator: Pierre LEBLOND | |
Institut Curie | Recruiting |
Paris, France, 75248 | |
Contact 00330144324270 | |
Principal Investigator: Isabelle Aerts | |
Gustave Roussy | Recruiting |
Villejuif Cedex, France, 94805 | |
Contact 0033142114661 | |
Principal Investigator: Birgit Geoerger | |
Germany | |
Charité Universitätsmedizin Berlin Campus Buch | Recruiting |
Berlin, Germany, 13353 | |
Contact 004930450666658 | |
Principal Investigator: Johannes Schulte | |
Universtitätsklinikum Essen AöR | Not yet recruiting |
Essen, Germany, 45147 | |
Contact 00492017233784 | |
Principal Investigator: Dirk Reinhardt | |
Hopp-Kindertumorzentrum Heidelberg (KiTZ) | Recruiting |
Heidelberg, Germany, 69120 | |
Contact 00496221424585 | |
Principal Investigator: Kristian Pajtler | |
Italy | |
Policlinico Univ. Agostino Gemelli | Not yet recruiting |
Roma, Italy, 00168 | |
Contact 00390630155556 | |
Principal Investigator: Antonio Ruggiero | |
Japan | |
National Cancer Center Hospital | Recruiting |
Chuo-ku, Tokyo, Japan, 104-0045 | |
Contact 81120023812 | |
Principal Investigator: Chitose Ogawa | |
Spain | |
Hospital Universitari Vall d'Hebron | Recruiting |
Barcelona, Spain, 08035 | |
Contact 0034934893093 | |
Principal Investigator: Lucas Moreno | |
Hospital Infantil Universitario Niño Jesús | Recruiting |
Madrid, Spain, 28009 | |
Contact 0034915035900 | |
Principal Investigator: Álvaro Lassaletta Atienza | |
Hospital Universitario La Fe de Valencia | Recruiting |
Valencia, Spain, 46026 | |
Contact 0034961244000-411532 | |
Principal Investigator: Antonio Juan |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04238819 |
Other Study ID Numbers: |
16950 I3Y-MC-JPCS ( Other Identifier: Eli Lilly and Company ) 2019-002931-27 ( EudraCT Number ) |
First Posted: | January 23, 2020 Key Record Dates |
Last Update Posted: | April 9, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CDK4 CDK6 Ewing's sarcoma Neuroblastoma Malignant rhabdoid tumor Rhabdomyosarcoma Osteosarcoma Brain tumor |
Glioblastoma Malignant glioma Diffuse intrinsic pontine glioma Medulloblastoma Ependymoma Solid tumor High-grade glioma |
Neoplasms Irinotecan Temozolomide Topoisomerase I Inhibitors Topoisomerase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents |