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A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
Phase 1 trial testing Drug Cocktail in Neoplasm Metastasis in 48 participants. Completed in 6 January 2021.
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 48 |
| Start date | 8 March 2016 |
| Primary completion | 4 February 2018 |
| Estimated completion | 6 January 2021 |
| Sites | 5 locations across United States |
Eli Lilly and Company — full company profile →
18 and older, any sex, with Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum concentration of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
| Group | Value | 95% CI |
|---|---|---|
| 100 mg Caffeine | 2890 | ± 29 |
| Abemaciclib + 100 mg Caffeine | 2950 | ± 33 |
Maximum concentration of S-warfarin after single dose of drug cocktail on Day 1 in Period 1and in combination with Abemaciclib on Day 8 in Period 2.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Warfarin | 561 | ± 35 |
| 200 mg Abemaciclib + 10 mg Warfarin | 526 | ± 35 |
Maximum concentration of dextromethorphan after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
| Group | Value | 95% CI |
|---|---|---|
| 30 mg Dextromethorphan | 3.18 | ± 182 |
| 200 Abemaciclib + 30 mg Dextromethorphan | 3.30 | ± 164 |
Maximum concentration of midazolam after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
| Group | Value | 95% CI |
|---|---|---|
| 0.2 mg Midazolam (Drug Cocktail) | 2.12 | ± 54 |
| 200 mg Abemaciclib + 0.2 mg Midazolam | 1.75 | ± 48 |
PK: AUC zero to infinity of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
| Group | Value | 95% CI |
|---|---|---|
| 100 mg Caffeine | 32500 | ± 72 |
| 200 mg Abemaciclib + 100 mg Caffeine | 47100 | ± 89 |
AUC (zero to infinity) of S-warfarin after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Warfarin | 21400 | ± 43 |
| 200 mg Abemaciclib + 10 mg Warfarin | 20600 | ± 40 |
PK: AUC (zero to infinity) of dextromethorphan after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
| Group | Value | 95% CI |
|---|---|---|
| 30 mg Dextromethorphan | 32.6 | ± 316 |
| 200 mg Abemaciclib + 30 mg Dextromethorphan | 32.1 | ± 238 |
PK: AUC (zero to infinity) of midazolam after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
| Group | Value | 95% CI |
|---|---|---|
| 0.2 mg Midazolam | 7.34 | ± 74 |
| 200 mg Abemaciclib + 0.2 mg Midazolam | 6.03 | ± 63 |
Mean change from predose in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose drug cocktail in Period 1.
| Group | Value | 95% CI |
|---|---|---|
| Drug Cocktail Period 1 | -2.5 | ± 13.9 |
| Group | Value | 95% CI |
|---|---|---|
| Drug Cocktail Period 1 | -0.7 | ± 10.1 |
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 1.
| Group | Value | 95% CI |
|---|---|---|
| Drug Cocktail Period 1 | -1.3 | ± 11.1 |
Mean change from baseline in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose of abemaciclib in Period 2, Day 1.
| Group | Value | 95% CI |
|---|---|---|
| 200 mg Abemaciclib | -7.8 | ± 15.2 |
| Group | Value | 95% CI |
|---|---|---|
| 200 mg Abemaciclib | -1.8 | ± 10.4 |
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 2, Day 1.
| Group | Value | 95% CI |
|---|---|---|
| 200 mg Abemaciclib | -0.2 | ± 12.5 |
Time frame: Baseline up to 46 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Drug Cocktail - Period 1 | 200 mg Abemaciclib - Perio… | 200 mg Abemaciclib + Drug … | 200 mg Abemaciclib - Perio… | Abemaciclib Safety Extensi… |
|---|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — | — | — |
| Oesophagitis | Gastrointestinal disorders | — | — | — | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — | — | — | — |
| Medical device complication | General disorders | — | — | — | — | — |
| Cholangitis | Hepatobiliary disorders | — | — | — | — | — |
| Clostridium difficile colitis | Infections and infestations | — | — | — | — | — |
| Diverticulitis | Infections and infestations | — | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — |
| Radius fracture | Injury, poisoning and procedural complications | — | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Reaction | System | Drug Cocktail - Period 1 | 200 mg Abemaciclib - Perio… | 200 mg Abemaciclib + Drug … | 200 mg Abemaciclib - Perio… | Abemaciclib Safety Extensi… |
|---|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — | — |
| International normalised ratio increased | Investigations | — | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — | — |
| Blood creatinine increased | Investigations | — | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — | — |
| Oedema | General disorders | — | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Vision blurred | Eye disorders | — | — | — | — | — |
Most-reported serious reactions: Abdominal pain, Ascites, Colitis, Diarrhoea, Lower gastrointestinal haemorrhage, Oesophagitis, Pancreatitis, Medical device complication.
Data from ClinicalTrials.gov NCT02688088 adverse events section.
This study is known as a "drug interaction study" and is being done to see how abemaciclib may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin, dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant will complete screening and four study periods in a fixed sequence, with the option to continue to receive abemaciclib in a safety extension phase. All participants will complete a safety follow-up.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing