Abemaciclib + Chemotherapy for Sarcoma
Trial Summary
What is the purpose of this trial?
This trial is testing whether adding a new drug called abemaciclib to standard cancer treatments can help children and young adults with Ewing's sarcoma that has come back or did not respond to previous treatments. Abemaciclib works by blocking proteins that help cancer cells grow, which may slow down or stop the tumor. Participation could last several months or more, depending on individual responses.
Do I need to stop my current medications to join the trial?
The trial requires participants to stop all previous cancer treatments or investigational agents at least 7 days before starting the trial. The protocol does not specify about other medications, but you should discuss with the trial team to understand if you need to stop any other medications.
Will I have to stop taking my current medications?
The trial requires participants to stop all previous cancer treatments or investigational agents at least 7 days before starting the study. It does not specify about other medications, so you may need to discuss your current medications with the trial team.
What data supports the idea that Abemaciclib + Chemotherapy for Sarcoma is an effective drug?
The available research shows that the combination of temozolomide and irinotecan, which are part of the chemotherapy regimen, has been effective in treating certain types of tumors. For example, in studies involving different types of cancer, this combination led to complete responses in several cases, meaning the tumors were no longer detectable. This suggests that the combination can be more effective than using either drug alone. Although the studies primarily focus on other cancers like glioma, the positive results indicate potential effectiveness for sarcoma as well.12345
What data supports the effectiveness of the drug combination of Abemaciclib, Irinotecan, and Temozolomide for treating sarcoma?
Research shows that the combination of Temozolomide and Irinotecan has been effective in treating various tumors, including neuroblastomas and glioblastomas, with better results than using either drug alone. This suggests potential effectiveness for other cancers, like sarcoma, when used in combination.12345
What safety data is available for the combination of Abemaciclib, Irinotecan, and Temozolomide in treating sarcoma?
The safety data for the combination of Irinotecan (CPT-11, Camptosar) and Temozolomide (Temodar) has been evaluated in several studies. In a Phase I trial, dose-limiting toxicities such as diarrhea, neutropenia, and thrombocytopenia were observed at certain doses. Another study reported dose-limiting grade 3 diarrhea, nausea, and vomiting, making some dosing regimens intolerable. The maximum tolerated dose and dose-limiting toxicity were also assessed in patients with recurrent malignant glioma. These studies indicate significant gastrointestinal toxicities and the need for careful dose management. However, specific safety data for the combination with Abemaciclib is not detailed in the provided research.34567
Is the combination of Abemaciclib, Irinotecan, and Temozolomide safe for humans?
The combination of Irinotecan and Temozolomide has been studied in humans, and some patients experienced side effects like diarrhea, low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). These side effects were dose-limiting, meaning they were severe enough to prevent increasing the dose further.34567
Is the drug combination of Irinotecan and Temozolomide promising for treating sarcoma?
Yes, the combination of Irinotecan and Temozolomide is promising for treating sarcoma, especially Ewing sarcoma. Studies show that this drug combination works well together and has been effective in patients, particularly in children with relapsed solid tumors. It has also been used widely in treating relapsed Ewing sarcoma.2891011
What makes the drug combination of Abemaciclib, Irinotecan, and Temozolomide unique for treating sarcoma?
This drug combination is unique because it uses Abemaciclib, a targeted therapy, alongside Irinotecan and Temozolomide, which have shown synergy (working better together) in treating relapsed Ewing sarcoma, a type of cancer. Temozolomide can cross the blood-brain barrier and has a good safety profile, making it effective in combination therapies.2891011
Research Team
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Principal Investigator
Eli Lilly and Company
Eligibility Criteria
This trial is for individuals with Ewing's Sarcoma that has returned or didn't respond to treatment. They must have a measurable tumor, weigh at least 10 kg, and have adequate organ function. Participants need to be off previous cancer treatments for at least 7 days and recovered from their effects. Pregnant or breastfeeding women can't join, nor can those who've had certain surgeries recently or are dealing with severe infections like HIV.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abemaciclib in combination with irinotecan and temozolomide for Ewing's sarcoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abemaciclib
- Irinotecan
- Temozolomide
Irinotecan is already approved in United States, European Union, Japan, Canada for the following indications:
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Small cell lung cancer
- Colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University