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Doxorubicin, Methotrexate
This combination uses doxorubicin to intercalate DNA and inhibit topoisomerase II, while methotrexate inhibits dihydrofolate reductase to disrupt nucleotide synthesis, together producing synergistic cytotoxic effects against cancer cells.
This combination uses doxorubicin to intercalate DNA and inhibit topoisomerase II, while methotrexate inhibits dihydrofolate reductase to disrupt nucleotide synthesis, together producing synergistic cytotoxic effects against cancer cells. Used for Breast cancer (likely primary indication given phase 3 status), Other solid tumors or hematologic malignancies (specific indication not provided).
At a glance
| Generic name | Doxorubicin, Methotrexate |
|---|---|
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Drug class | Chemotherapy combination (anthracycline + antimetabolite) |
| Target | Topoisomerase II (doxorubicin); Dihydrofolate reductase (methotrexate) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Doxorubicin is an anthracycline chemotherapy agent that intercalates into DNA and prevents topoisomerase II-mediated DNA repair, leading to DNA strand breaks and cell death. Methotrexate is an antimetabolite that inhibits dihydrofolate reductase, blocking thymidylate synthase and reducing dTMP production, thereby impairing DNA synthesis. The combination exploits complementary mechanisms to enhance cytotoxicity across multiple cancer cell populations.
Approved indications
- Breast cancer (likely primary indication given phase 3 status)
- Other solid tumors or hematologic malignancies (specific indication not provided)
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Cardiotoxicity (doxorubicin-related)
- Mucositis
- Nausea and vomiting
- Alopecia
- Hepatotoxicity
- Nephrotoxicity (methotrexate-related)
Key clinical trials
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma (PHASE2, PHASE3)
- Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer (PHASE2, PHASE3)
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
- Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults (PHASE3)
- CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL (PHASE3)
- Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Doxorubicin, Methotrexate CI brief — competitive landscape report
- Doxorubicin, Methotrexate updates RSS · CI watch RSS
- Gustave Roussy, Cancer Campus, Grand Paris portfolio CI