NCT01005472 is a Phase 1 clinical trial of sunitinib malate in Metastatic Melanoma, sponsored by Jonsson Comprehensive Cancer Center.

Who is sponsoring NCT01005472?

NCT01005472 is sponsored by Jonsson Comprehensive Cancer Center.

What drugs are being tested in NCT01005472?

Interventions in NCT01005472: sunitinib malate, temozolomide.

What condition does NCT01005472 study?

NCT01005472 studies Metastatic Melanoma.

Is NCT01005472 still recruiting?

NCT01005472 is currently completed. Last updated 3 August 2020.

Last reviewed 2020-08-03 · How we verify

NCT01005472

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma

Completed Phase 1 Last updated 3 August 2020

What this trial tests

Phase 1 trial testing sunitinib malate in Metastatic Melanoma in 16 participants. Completed in 17 January 2018.

Timeline

1 December 2008

Primary endpoint
17 January 2018

17 January 2018

Quick facts

Lead sponsor	Jonsson Comprehensive Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 December 2008
Primary completion	17 January 2018
Estimated completion	17 January 2018
Sites	1 location across United States

Drugs / interventions tested

sunitinib malate (sunitinib-malate) — full drug profile →
temozolomide (temozolomide) — full drug profile →

Conditions studied

Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sunitinib malate may kill more tumor cells. Phase II was never conducted due to toxicity in phase I. PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate when given together with temozolomide and to see how well they work in treating patients with stage III or stage IV malignant melanoma.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Melanoma treatment in review.
Domingues B, Lopes JM, Soares P, Pópulo H. · · 2018 · cited 432× · PMID 29922629 · DOI 10.2147/itt.s134842
Hypoxia-dependent drivers of melanoma progression.
D'Aguanno S, Mallone F, Marenco M, Del Bufalo D, et al · · 2021 · cited 67× · PMID 33964953 · DOI 10.1186/s13046-021-01926-6
A molecular revolution in uveal melanoma: implications for patient care and targeted therapy.
Harbour JW, Chao DL. · · 2014 · cited 51× · PMID 24480708 · DOI 10.1016/j.ophtha.2013.12.014
Melanoma therapeutics: a literature review.
Dhanyamraju PK, Patel TN. · · 2022 · cited 36× · PMID 35260531 · DOI 10.7555/jbr.36.20210163
The role of signaling pathways mediated by the GPCRs CysLTR1/2 in melanocyte proliferation and senescence.
Huber T, Horioka-Duplix M, Chen Y, Saca VR, et al · · 2024 · cited 5× · PMID 39288219 · DOI 10.1126/scisignal.adp3967
Unraveling vascular mechanisms in melanoma: roles of angiogenesis and vasculogenic mimicry in tumor progression and therapeutic resistance.
Serratì S, Raho L, De Giosa G, Porcelli L, et al · · 2025 · PMID 41251262 · DOI 10.20892/j.issn.2095-3941.2025.0048

Verify or expand the search:

Other trials of sunitinib malate

Trials testing the same drug.

NCT01158222 — Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer · Phase 2 · completed
NCT00482755 — Sunitinib in Treating Patients With Newly Diagnosed Stage II or Stage III Breast Cancer That Can Be Removed by Surgery · Phase 2 · completed
NCT00702884 — Sunitinib in Treating Patients With Relapsed or Refractory Esophageal or Gastroesophageal Junction Cancer · Phase 2 · completed
NCT00616122 — Sunitinib, Cyclophosphamide, and Methotrexate in Treating Patients With Metastatic Breast Cancer · Phase 1, PHASE2 · terminated

Other recruiting trials for Metastatic Melanoma

Currently open trials in the same condition.

NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
NCT07237100 — Mirdametinib in Patients With Advanced NF1-mutant Melanoma · Phase 2 · recruiting
NCT07086105 — A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma · Phase 1 · recruiting
NCT07112170 — Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma · NA · recruiting
NCT06488365 — In Vivo Liquid Biopsy of Melanoma (Cytophone) · NA · recruiting

Other Jonsson Comprehensive Cancer Center trials

Trials by the same sponsor.

NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio · Phase 3 · not yet recruiting
NCT07517211 — A Prospective Study of Physical Function in Adults Who Receive Systemic Therapy for Stage I-III Gastroesophageal Cancer, · not yet recruiting
NCT07191717 — Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Resi · Phase 2 · not yet recruiting
NCT07468903 — Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate Cancer · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01005472 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center
Last refreshed: 3 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01005472.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing