Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rifampicin · 2 trials · 2 indications
Rate and extent of absorption of AZD9291 by assessment of maximum plasma concentration at steady state (Css,max). AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).
Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).
Rate and extent of absorption of olaparib following single oral doses of olaparib tablet formulation by assessment of maximum plasma olaparib concentration (Cmax). Olaparib doses are first without, then with rifampicin.
Rate and extent of absorption of olaparib following single oral doses of olaparib tablet formulation by assessment of area under the plasma concentration time curve from zero to infinity (AUC). Olaparib doses are first without, then with rifampicin.
Rate and extent of absorption of olaparib following single oral doses of olaparib tablet formulation by assessment of area under the plasma concentration time curve from zero to the last measurable time point, AUC0-t, if AUC is not adequately estimable. Olaparib doses are first without, then with rifampicin.
| Arm | Type | Description |
|---|---|---|
| Rifampicin and AZD9291 | EXPERIMENTAL | Sequential treatments of AZD9291 alone followed by AZD9291 +rifampicin, followed by AZD9291 alone. |
| Olaparib alone, olaparib+rifampicin | EXPERIMENTAL | Sequential treatments of olaparib alone followed by olaparib+rifampicin, with a washout period inbetween. |
| Name | Type | Description |
|---|---|---|
| Pharmacokinetic sampling - AZD9291 | PROCEDURE | Blood sampling to measure AZD9291 |
| Rifampicin | DRUG | Rifampicin (CYP inducer) 600mg taken once daily from Day 29 to Day 49 (Part A) |
| AZD9291 tablet dosing | DRUG | Part A: AZD9291 80mg tablet taken daily from Days 1 to 77. Part B: AZD9291 80mg tablet taken daily for 12 months. |
| Pharmacokinetic sampling - rifampicin | PROCEDURE | Blood sampling to measure rifampicin levels |
| Pharmacokinetic sampling - AZ5140 and AZ7550 | PROCEDURE | Blood samples to measure levels of AZ5140 and AZ7550 |
| Pharmacokinetic sampling | PROCEDURE | Blood sampling to measure olaparib, rifampicin and 4β-hydroxycholesterol |
| Olaparib tablet dosing | DRUG | Olaparib 300mg tablet taken on Days 1 and 14 (Part A). Part B dosing is 300mg olaparib bi-daily |
For inclusion in the study patient should fulfil the following criteria: 1\. Male or female, aged at least 18 years. 2. Histological or cytological confirmation diagnosis of NSCLC. 3. Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI, eg gef...
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Rifampicin is an antibiotic being studied in oncology clinical trials for its effects on drug interactions. It is being evaluated in patients with advanced solid tumours and EGFRm+ non small cell lung cancer, specifically to assess how it affects blood levels of other cancer drugs.
Rifampicin is being developed by AstraZeneca PLC, which trades under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's interactions with its oncology treatments.
Rifampicin is in Phase 1 clinical development. It is an investigational drug being studied for its effects on drug metabolism in cancer patients, and it is not yet approved for any oncology indication.
Rifampicin has been studied in two completed Phase 1 trials. NCT01929603 assessed its effect on olaparib blood levels in patients with advanced solid tumours, and NCT02197247 assessed its effect on AZD9291 blood levels in patients with EGFRm+ non small cell lung cancer.
Rifampicin is a CYP inducer, meaning it increases the activity of certain liver enzymes that metabolize drugs. This can lower blood levels of co-administered medications, which is why it is being studied to understand its interactions with cancer therapies.