18 and older, female only, with Endometrial Adenocarcinoma or Endometrial Endometrioid Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response RatePrimary· Up to 7 years
Objective response rate, defined as the rate of complete or partial response as defined by the Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance
Group
Value
95% CI
Treatment (Sunitinib Malate)
6
Treatment (Sunitinib Malate)
6
Treatment (Sunitinib Malate)
16
Treatment (Sunitinib Malate)
5
Number of Participants With Prolonged Stable DiseaseSecondary· Up to 7 years
Described as the best response of stable disease that is maintained for atleast 6 months
Group
Value
95% CI
Treatment (Sunitinib Malate)
0
Overall SurvivalSecondary· Up to 7 years
Estimated using the Kaplan-Meier method.
Group
Value
95% CI
Treatment (Sunitinib Malate)
19.4
6.2 – 60
Number of Participants With Adverse Effects Assessed by CTCAE Version 3.0Secondary· Up to 7 years
Number of participants that experience at east 1 adverse event while on trial, according to the CTCAE.
Group
Value
95% CI
Treatment (Sunitinib Malate)
30
Time to ProgressionSecondary· Up to 7 years
The length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body. Assessed by Kaplan and Meier method
Group
Value
95% CI
Treatment (Sunitinib Malate)
3
2.5 – 5.3
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from baseline, onward to end of treatment up to 5 years total..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well sunitinib malate works in treating patients with endometrial cancer that has come back after a period of improvement (recurrent) or has spread to other places in the body (metastatic). Sunitinib 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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05687123 — Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors
· Phase 1
· recruiting
NCT03909724 — Pulsatile High-dose Sunitinib Versus TAS-102 in Patients With Metastatic Colorectal Carcinoma (mCRC)
· Phase 2, PHASE3
· unknown
NCT03463460 — Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer
· Phase 2
· active not recruiting
NCT03541902 — Cabozantinib or Sunitinib Malate in Treating Participants With Metastatic Variant Histology Renal Cell Carcinoma
· Phase 2
· active not recruiting
NCT02761057 — Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed
· Phase 2
· completed
Other recruiting trials for Endometrial Adenocarcinoma
Currently open trials in the same condition.
NCT07077876 — Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Tre
· recruiting
NCT06917092 — QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer
· Phase 2
· recruiting
NCT05824481 — Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer
· Phase 2
· active not recruiting
NCT05548296 — A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
· Phase 2
· recruiting
NCT05112601 — Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
· Phase 2
· recruiting
Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem
· Phase 1, PHASE2
· recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After
· Phase 1
· not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel
· Phase 2
· not yet recruiting
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 National Cancer Institute (NCI)
Last refreshed: 17 February 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/NCT00478426.