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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
Phase 1 trial testing Dalteparin in Clear Cell Sarcoma of the Kidney in 16 participants. Completed in 21 April 2017.
14 October 2015
Quick facts
| Lead sponsor | Roswell Park Cancer Institute |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 6 February 2010 |
| Primary completion | 14 October 2015 |
| Estimated completion | 21 April 2017 |
| Sites | 4 locations across Netherlands, United States |
Drugs / interventions tested
- Dalteparin
- Pharmacological Study — full drug profile →
- Sunitinib Malate (sunitinib-malate) — full drug profile →
Conditions studied
- Clear Cell Sarcoma of the Kidney — all drugs for Clear Cell Sarcoma of the Kidney →
- Recurrent Renal Cell Carcinoma — all drugs for Recurrent Renal Cell Carcinoma →
- Stage III Renal Cell Cancer — all drugs for Stage III Renal Cell Cancer →
- Stage IV Renal Cell Cancer — all drugs for Stage IV Renal Cell Cancer →
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):
-
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:
- PubMed search for NCT01061411
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dalteparin
Trials testing the same drug.
- NCT06628778 — Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids · Phase 3 · not yet recruiting
- NCT05171075 — A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE · Phase 3 · terminated
- NCT04850378 — Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome · Phase 1, PHASE2 · completed
- NCT03297359 — WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism · Phase 2 · terminated
- NCT03139487 — A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral · Phase 2 · unknown
Other recruiting trials for Clear Cell Sarcoma of the Kidney
Currently open trials in the same condition.
- NCT00898365 — Study of Kidney Tumors in Younger Patients · active not recruiting
Other Roswell Park Cancer Institute trials
Trials by the same sponsor.
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- NCT06943664 — Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-I · Phase 2 · not yet recruiting
- NCT06827054 — Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids · Phase 2 · not yet recruiting
- NCT06334016 — Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream · EARLY_PHASE1 · not yet recruiting
- NCT06670976 — Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01061411 (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 Roswell Park Cancer Institute
- Last refreshed: 5 August 2022
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