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NCT01061411

Dalteparin and Sunitinib Malate as First-Line Therapy in Treating Patients With Kidney Cancer That is Metastatic or Cannot Be Removed by Surgery

Completed Phase 1 Last updated 5 August 2022
What this trial tests

Phase 1 trial testing Dalteparin in Clear Cell Sarcoma of the Kidney in 16 participants. Completed in 21 April 2017.

Timeline
6 February 2010
Primary endpoint
14 October 2015
21 April 2017

Quick facts

Lead sponsorRoswell Park Cancer Institute
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment16
Start date6 February 2010
Primary completion14 October 2015
Estimated completion21 April 2017
Sites4 locations across Netherlands, United States

Drugs / interventions tested

Conditions studied

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, any sex, with Clear Cell Sarcoma of the Kidney or Recurrent Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of dalteparin when given together with sunitinib malate in treating patients with kidney cancer that has spread to other parts of the body or cannot be removed by surgery. Anticoagulants, such as dalteparin, help prevent blood clots and have been shown to increase survival in patients with cancer. Anticoagulants may also prevent the formation of new blood vessels. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by inhibiting new blood vessels and blocking blood flow to the tumor. Giving dalteparin together with sunitinib malate may starve tumors and kill more tumor cells.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Thromboprophylaxis guidelines in cancer with a primary focus on ambulatory patients receiving chemotherapy: a review from the Southern Network on Adverse Reactions (SONAR).
    Maxwell WD, Bennett CL. · · 2012 · cited 9× · PMID 23111863 · DOI 10.1055/s-0032-1328893

Verify or expand the search:

Other trials of Dalteparin

Trials testing the same drug.

Other recruiting trials for Clear Cell Sarcoma of the Kidney

Currently open trials in the same condition.

Other Roswell Park Cancer Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT01061411.

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