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Study to Investigate the Effect of Rifampin and Itraconazole on the Action of Pamiparib in Participants With Cancer
Phase 1 trial testing pamiparib 60 mg in Solid Tumor in 25 participants. Completed in 6 August 2021.
| Lead sponsor | BeiGene |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 25 |
| Start date | 29 May 2019 |
| Primary completion | 25 October 2019 |
| Estimated completion | 6 August 2021 |
| Sites | 4 locations across Georgia, Slovakia, Poland, Moldova |
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18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Part A: Pamiparib | 1970 | 1060.0 – 2700.0 |
| Part A: Pamiparib + Rifampin | 1820 | 1170.0 – 2500.0 |
| Group | Value | 95% CI |
|---|---|---|
| Part B: Pamiparib | 730.5 | 374.0 – 1130.0 |
| Part B: Pamiparib + Itraconazole | 752.5 | 302.0 – 1130.0 |
| Group | Value | 95% CI |
|---|---|---|
| Part A: Pamiparib | 28868 | 14680.8 – 46910.6 |
| Part A: Pamiparib + Rifampin | 18351 | 11097.3 – 24186.8 |
| Group | Value | 95% CI |
|---|---|---|
| Part B: Pamiparib | 9163 | 1797.5 – 20891.1 |
| Part B: Pamiparib + Itraconazole | 8894 | 1528.1 – 19356.9 |
| Group | Value | 95% CI |
|---|---|---|
| Part A: Pamiparib | 28142 | 14776 – 51942 |
| Part A: Pamiparib + Rifampin | 18563 | 11183 – 25615 |
| Group | Value | 95% CI |
|---|---|---|
| Part B: Pamiparib | 10072 | 1828.4 – 25529.9 |
| Part B:Pamiparib + Itraconazole | 9353 | 1541.9 – 23171.0 |
| Group | Value | 95% CI |
|---|---|---|
| Part A: Pamiparib | 14642.90 | 9502.6 – 20992.6 |
| Part A: Pamiparib + Rifampin | 12262.61 | 7908.4 – 15230.0 |
| Group | Value | 95% CI |
|---|---|---|
| Part B: Pamiparib | 5097.06 | 1640.4 – 8313.2 |
| Part B: Pamiparib + Itraconazole | 4647.47 | 1413.5 – 8879.2 |
| Group | Value | 95% CI |
|---|---|---|
| Part A: Pamiparib | 11821.06 | 7678.6 – 16561.4 |
| Part A: Pamiparib + Rifampin | 10515.14 | 6888.8 – 12813.6 |
| Group | Value | 95% CI |
|---|---|---|
| Part B: Pamiparib | 4267.86 | 1525.3 – 6350.2 |
| Part B:Pamiparib + Itraconazole | 3812.39 | 1315.8 – 7325.8 |
| Group | Value | 95% CI |
|---|---|---|
| Part A: Pamiparib | 2.000 | 1.00 – 4.00 |
| Part A: Pamiparib + Rifampin | 2.000 | 1.00 – 4.05 |
| Group | Value | 95% CI |
|---|---|---|
| Part B: Pamiparib | 2.000 | 0.98 – 4.02 |
| Part B:Pamiparib + Itraconazole | 1.000 | 0.95 – 2.02 |
Time frame: From the date informed consent has been signed until last study medication dose plus 30 days (up to approximately 26 months). Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Core Phase: Arm A: Pamipar… | Core Phase: Arm B: Pamipar… | Extension Phase |
|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — | — |
| Reaction | System | Core Phase: Arm A: Pamipar… | Core Phase: Arm B: Pamipar… | Extension Phase |
|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Oedema peripheral | General disorders | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Blood creatinine increased | Investigations | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — |
| White blood cell count decreased | Investigations | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Macrocytosis | Blood and lymphatic system disorders | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — |
| Palpitations | Cardiac disorders | — | — | — |
| Hyperthyroidism | Endocrine disorders | — | — | — |
| Retinal haemorrhage | Eye disorders | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Duodenogastric reflux | Gastrointestinal disorders | — | — | — |
| Eructation | Gastrointestinal disorders | — | — | — |
| Gastritis | Gastrointestinal disorders | — | — | — |
| Gastritis erosive | Gastrointestinal disorders | — | — | — |
| Gingival bleeding | Gastrointestinal disorders | — | — | — |
| Catheter site inflammation | General disorders | — | — | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — | — | — |
| Jaundice | Hepatobiliary disorders | — | — | — |
| Bronchitis | Infections and infestations | — | — | — |
| Influenza | Infections and infestations | — | — | — |
| Rhinitis | Infections and infestations | — | — | — |
| Bilirubin conjugated increased | Investigations | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — |
| Blood urea increased | Investigations | — | — | — |
| C-reactive protein increased | Investigations | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Weight decreased | Investigations | — | — | — |
Most-reported serious reactions: Anaemia, Vomiting, Intestinal obstruction.
Data from ClinicalTrials.gov NCT03994211 adverse events section.
The study was an open-label, parallel-group, fixed-sequence study in male and female cancer patients. The study consists of 2 phases: the Core Phase, which is divided into Part A and Part B, and the Extension Phase. Part A investigated the effect of CYP3A induction by rifampin on the single dose pharmacokinetics (PK) of pamiparib, and Part B investigated the effect of CYP3A inhibition by itraconazole on the single dose PK of pamiparib. Participants were offered participation in the Extension Phase, in which they received pamiparib until progression of disease, unacceptable toxicity, withdrawal of consent, or any other reason for discontinuation.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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