Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clarithromycin · 3 trials · 2 indications
The MTD is defined as the highest dose tested in which fewer than 33% of patients experience a dose limiting toxicity and at least 6 patients have been treated at that dose. The MTD will be the recommended Phase 2 dose, provided that other safety considerations are acceptable.
| Arm | Type | Description |
|---|---|---|
| Treatment (PiC-D therapy) | EXPERIMENTAL | Patients receive pomalidomide PO QD on days 1-21; ixazomib citrate PO on days 1, 8, and 15; clarithromycin PO BID on days 15-21 of course 1 and days 1-21 of courses 2-6; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive pomalidomide, ixazomib citrate, and dexamethasone as above and receive clarithromycin PO BID or QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Clarithromycin + Amoxicillin + Bismuth + Vonoprazan | EXPERIMENTAL | Clarithromycin 500 milligram (mg), tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14. |
| Clarithromycin + Amoxicillin + Bismuth + Esomeprazole | ACTIVE_COMPARATOR | Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14. |
| Clarithromycin + Amoxicillin + Bismuth + Lansoprazole | ACTIVE_COMPARATOR | Clarithromycin 500 milligram (mg), tablets, orally, twice daily, along with amoxicillin 1000 mg capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14. |
| Clarithromycin + Amoxicillin + Bismuth + TAK-438 | EXPERIMENTAL | Clarithromycin 500 mg, tablets, orally, twice daily, along with amoxicillin 1000 mg, capsules, orally, twice daily, tripotassium bismuth dicitrate 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14. |
| Name | Type | Description |
|---|---|---|
| Clarithromycin | DRUG | Given PO |
| Dexamethasone | DRUG | Given PO |
| Ixazomib Citrate | DRUG | Given PO |
| Pomalidomide | DRUG | Given PO |
| Amoxicillin | DRUG | Amoxicillin capsules. |
| Bismuth potassium citrate | DRUG | Bismuth potassium citrate tablets. |
| Esomeprazole | DRUG | Esomeprazole tablets. |
| Vonoprazan | DRUG | Vonoprazan tablets. |
| Tripotassium bismuth dicitrate | DRUG | Tripotassium bismuth dicitrate tablets |
| Lansoprazole | DRUG | Lansoprazole capsules |
| TAK-438 | DRUG | TAK-438 tablets |
Inclusion Criteria: * Voluntary written consent * Patients must have a confirmed biopsy diagnosis of a multiple myeloma * Submission of original biopsy for review and verification by hematopathologist at local institution * Patients must have measurable disease according to International Myeloma Wo...
Clarithromycin is a small molecule being studied for use in myeloma and Helicobacter pylori infection. In clinical trials, it is being evaluated as part of combination therapy for multiple myeloma and in drug interaction studies related to Helicobacter pylori treatment. It is currently in Phase 1 clinical development.
Clarithromycin is a macrolide antibiotic that works by inhibiting bacterial protein synthesis. It binds to the 50S ribosomal subunit of susceptible bacteria, blocking peptide bond formation and thereby stopping bacterial growth. This mechanism underlies its use in treating Helicobacter pylori infections.
Clarithromycin is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is conducting clinical trials to evaluate the drug for multiple myeloma and Helicobacter pylori infections.
Clarithromycin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the indications being studied. The ongoing Phase 1 trial is active but not recruiting patients.
Clarithromycin is involved in three clinical trials. NCT02542657 is a Phase 1 study combining ixazomib, pomalidomide, clarithromycin, and dexamethasone for multiple myeloma. NCT02892409 and NCT04753437 are Phase 1 studies related to Helicobacter pylori, including a drug interaction study and a vonoprazan study.
No, Clarithromycin is not the same as TAK-438. TAK-438 is a separate drug being studied in combination with clarithromycin for Helicobacter pylori infection. Clarithromycin is the antibiotic component, while TAK-438 is a potassium-competitive acid blocker.