Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abacavir · 1 trial · 1 indication
The number of participants experiencing dose-limiting toxicity (DLT) during the first 28 days of antiretroviral therapy (ART) will be reported. Toxicity will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
The number of participants experiencing serious adverse events (SAEs) and Grade 3 or higher adverse events (AEs) will be reported. SAEs and AEs will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
| Arm | Type | Description |
|---|---|---|
| Part 1: STARLITE Dose Escalation/De-Escalation Cohort | EXPERIMENTAL | Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) on Day 0 after stereotactic needle biopsy. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and dose escalation/de-escalation of Ritonavir (RTV), to determine the recommended Phase 2 dose (RP2D) of Ritonavir. Participants will receive up to 12 months of ART. Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days). Participants will be administered Temozolomide up to Day 180. Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months. |
| Part 2: STARLITE Dose Expansion Cohort | EXPERIMENTAL | Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) after biopsy on Day 0. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and the recommended phase 2 dose (RP2D) of Ritonavir determined in Part 1. Participants will receive up to 12 months of ART. Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days), and Temozolomide therapy, during and following radiotherapy up to Day 180. Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months. Total participation is approximately two years. |
| Name | Type | Description |
|---|---|---|
| Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT) | PROCEDURE | Participants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure, following stereotactic needle biopsy. |
| Abacavir | DRUG | Participants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART). |
| Lamivudine | DRUG | Participants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART) |
| Ritonavir | DRUG | Participants will take one tablet of Ritonavir (RTV) orally twice daily, as part of combination antiretroviral therapy (ART), at one of the following dose levels: * Dose Level 1: 100mg * Dose Level 2 (starting dose): 300mg * Dose Level 3: 400mg * Dose Level 4: 600mg |
| Temozolomide | DRUG | Participants will take Temozolomide (TMZ) via capsule orally, during and after focal radiotherapy, as part of standard of care adjuvant therapy. During focal radiotherapy, Temozolomide will be administered at a dose of 75 mg/m2 once daily for six weeks (42 days) on a continuous dosing regimen, including weekends and holidays. After completion of focal radiotherapy, Temozolomide will be administered at 150 mg/m\^2 on days 1 through 5 of Cycle 1, and at 200 mg/m\^2 on days 1 through 5 of Cycles 2 through 6, for a total of six 28-day cycles of maintenance therapy. |
| Focal Radiotherapy | RADIATION | Participants will be administered focal radiotherapy for six weeks (42 days), as part of adjuvant therapy, at a total dose of 50-60 grays (Gy) in 1.8-2.0 Gy fractions, depending on prognosis and as determined by the treating radiation oncologist. |
Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI. a. For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists (Section 4.4.1). 3. Uni-focal or butterfly gliomas that ca...
Abacavir is an investigational small molecule being developed for the treatment of high grade glioma, a type of brain cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with unresectable high grade gliomas.
Abacavir is being developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker MDT. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with high grade glioma.
Abacavir is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The ongoing Phase 1 trial is recruiting participants to evaluate the treatment for unresectable high grade gliomas.
Abacavir is being studied in a Phase 1 clinical trial with the identifier NCT06428045, titled "STARLITE for Unresectable High-Grade Gliomas." The trial is currently recruiting 24 participants in the United States. It is a controlled, open-label study that requires a biomarker for patient selection.
Abacavir is a distinct investigational drug being developed for high grade glioma. It is a small molecule therapeutic and is not known to be identical to any other approved or investigational medication. Its mechanism of action is not publicly disclosed in the available clinical trial information.