deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT01321437

Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma

Phase 2 Study of the Anti-Angiogenesis Agent Axitinib (AG-013736) in Patients With Stage III Malignant Melanoma

Sponsor: Pfizer

Updated 11 times since 2017 Last updated: Dec 30, 2020 Started: Dec 31, 2011 Primary completion: Dec 31, 2016 Completion: Dec 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Malignant Melanoma and Melanoma and is currently completed. Pfizer leads this study, which shows 11 recorded versions since 2011 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

The American Cancer Society estimates that there will be about 68,720 new cases of melanoma (29,900 in men and 25,200 in women) annually in the United States, and about 8,650 people will die from this cancer. The systemic therapy of advanced disease remains palliative until new agents are found that might improve the survival of patients with stage III melanoma. Melanomas are often vascular, and a decrease in the number of blood vessels that supply the tumor may starve it of needed nutrients. An approach to blocking the growth of blood vessels that supply the tumor is to inhibit the vascular endothelial growth factor receptor tyrosine kinase (VEGFR TK) signaling pathway. Axitinib (AG 013736) is a VEGFR TK inhibitor. Because of the poor prognosis of patients with stage III melanoma and indications that anti-angiogenesis compounds might have clinically meaningful activity in this disease, a Phase 2 trial of the vascular endothelial growth factor receptor tyrosine kinase (VEGFR TK) inhibitor Axitinib (AG 013736) is warranted.

The American Cancer Society estimates that there will be about 68,720 new cases of melanoma (29,900 in men and 25,200 in women) annually in the United States, and about 8,650 people will die from this cancer. The systemic therapy of advanced disease remains palliative until new agents are found that might improve the survival of patients with stage III melanoma.

Melanomas are often vascular, and a decrease in the number of blood vessels that supply the tumor may starve it of needed nutrients. An approach to blocking the growth of blood vessels that supply the tumor is to inhibit the vascular endothelial growth factor receptor tyrosine kinase (VEGFR TK) signaling pathway. Axitinib (AG 013736) is a VEGFR TK inhibitor.

Because of the poor prognosis of patients with stage III melanoma and indications that anti-angiogenesis compounds might have clinically meaningful activity in this disease, a Phase 2 trial of the vascular endothelial growth factor receptor tyrosine kinase (VEGFR TK) inhibitor Axitinib (AG 013736) is warranted.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Mar 2019 · 9 months · monthly snapshotActive Not Recruiting~Mar 2019 – ~Jan 2021 · 22 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotActive Not Recruiting~Feb 2021 – ~Dec 2022 · 22 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

Show 6 earlier versions
  1. Feb 2021 — Dec 2022 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  2. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE2

  3. Mar 2019 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  4. Jun 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  6. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Dec 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pfizer
  • University of California, Irvine
Data source: University of California, Irvine

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations