Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02308020) looked at a drug called abemaciclib in people who had cancer that had spread to the brain — known as brain metastases. The trial was divided into several groups based on cancer type: hormone receptor-positive, HER2-positive breast cancer (Part A, 27 people); hormone receptor-positive, HER2-negative breast cancer (Part B, 58 people); a surgical group (Part C, 9 people); non-small cell lung cancer (Part D, 28 people); melanoma (Part E, 23 people); and a mixed group (Part F, 17 people). In total, 162 people were enrolled and all received at least one dose of the study drug. The main thing being measured was whether tumours in the brain shrank or disappeared — called the objective intracranial response rate. The reported data shows that for the primary outcome — the percentage of participants whose brain tumours completely disappeared or shrank by at least 30% — the results were: 0% in the HER2-positive breast cancer group (Part A), 5.8% in the HER2-negative breast cancer group (Part B), 0% in the lung cancer group (Part D), and 0% in the melanoma group (Part E). For secondary outcomes, the reported data shows that the proportion of participants whose disease was recorded as either responding or staying stable ("disease control") was 52.2% (Part A), 71.2% (Part B), 43.5% (Part D), and 31.8% (Part E). Among the small number of participants in Part B who did show a response, the reported duration of that response was 8.8 months on average. Overall survival — meaning the midpoint time from the start of the study until death from any cause — was reported as approximately 10.1 months (Part A), 13.4 months (Part B), 7.1 months (Part D), and 2.9 months (Part E). Data on duration of response was not reported for Parts A, D, or E. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 32694159) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Melanoma Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have cancer that has spread to the brain (brain metastases) from hormone receptor positive breast cancer, non-small cell lung cancer (NSCLC), or melanoma.
- If joining Part A, you have HER2-positive breast cancer; if joining Part B, you have HER2-negative breast cancer.
- If joining Part C, you have hormone receptor positive breast cancer, NSCLC, or melanoma with brain tumors that doctors recommend removing with surgery, and you agree to provide a tissue sample after 5–14 days of taking the study drug.
- If joining Part D, you have any type of non-small cell lung cancer.
- If joining Part E, you have any type of melanoma.
- If joining Part F, you have hormone receptor positive breast cancer, NSCLC, or melanoma that has spread to the fluid and lining around the brain and spinal cord (confirm with trial site).
- For Parts A, B, D, and E: you have at least one measurable brain tumor that is 10mm or larger at its widest point.
- For Part C: you have brain tumor(s) that doctors have recommended removing through surgery.
- You have already finished a previous brain treatment (such as surgery, whole-brain radiation, or targeted radiation) at least 14 days before starting the study drug, and you have recovered from its side effects.
- If you are taking steroid medications, your dose has been stable or reducing for at least 7 days before your baseline brain scan.
- You are functioning reasonably well in daily life, as measured by a standard performance scale score of 70 or above (confirm with trial site).
- Doctors expect you to live for at least 12 weeks.
- For hormone receptor positive breast cancer participants in Parts A, B, C, and F: if you are currently on hormone therapy, you may continue it if your cancer outside the brain has been stable for at least 3 months and your brain cancer has continued to grow while on that therapy — otherwise, you would need to stop hormone therapy before joining.
- For HER2-positive breast cancer participants in Parts A, C, and F: you may continue receiving trastuzumab (an IV cancer treatment) at the same time as the study drug.
- For NSCLC participants in Parts C, D, and F: if you are currently receiving gemcitabine or pemetrexed, you may continue one of these if your cancer outside the brain has been stable for at least 6 weeks and your brain cancer has continued to grow while on that treatment.
- Your major organs (such as liver and kidneys) are working well enough as shown by blood tests.
Who may not be able to join:
- You need immediate brain treatment right now, such as surgery, whole-brain radiation, or targeted radiation.
- You are currently taking certain anti-seizure medications that affect how the body processes drugs (enzyme-inducing antiepileptic drugs) (confirm with trial site).
- You have significant bleeding inside the brain that is causing symptoms.
- For Parts A, B, C, D, and E: your cancer has spread to the fluid and lining around the brain and spinal cord (leptomeningeal metastases).
- You have had more than 2 seizures in the 4 weeks before joining the study.
- For Parts A, B, D, E, and F: you have previously taken any CDK4/6 inhibitor drug (a type of targeted cancer treatment); for Part C, you may have taken palbociclib or ribociclib before, but not the study drug abemaciclib.
- You have a medical reason why you cannot have an MRI scan with contrast dye.
- You have an ongoing long-term condition that causes persistent diarrhea.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Call 1-877-CTLILLY (1-877-285-459) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.