A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
Active, enrolledPhase 2Results postedLast updated 3 December 2025
What this trial tests
Phase 2 trial testing Computed Tomography in Stage III Uterine Corpus Leiomyosarcoma AJCC v8 in 23 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, female only, with Stage III Uterine Corpus Leiomyosarcoma AJCC v8 or Stage IV Uterine Corpus Leiomyosarcoma AJCC v8. 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.
Confirmed Objective Response Rate (ORR) (Complete Response + Partial Response)Primary· Within first 6 months of study treatment
Will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria assessed by MRI: Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm); Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. A response rate of 10% is considered inactive and unworthy of further study. A response rate of 35% would be promising for further study among patients with advanced uter
Group
Value
95% CI
Treatment (Olaparib, Temozolomide)
5
Number of Patients Experiencing Adverse EventsSecondary· Up to 2 years after study treatment
Recorded at each clinical visit and will be categorized according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Number of patients experiencing a grade 3 or greater adverse event will be reported.
Group
Value
95% CI
Treatment (Olaparib, Temozolomide)
20
Adverse events — posted to ClinicalTrials.gov
Time frame: 34 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Olaparib, Temozolomide)
Serious: 19/22 (86%)
Deaths: 8/22
Serious adverse events (15 terms)
Reaction
System
Treatment (Olaparib, Temoz…
Neutrophil count decreased
Investigations
—
Platelet count decreased
Investigations
—
White blood cell decreased
Investigations
—
Lymphocyte count decreased
Investigations
—
Abdominal pain
Gastrointestinal disorders
—
Activated partial thromboplastin time prolonged
Investigations
—
Acute kidney injury
Renal and urinary disorders
—
Allergic reaction
Immune system disorders
—
Atrial fibrillation
Cardiac disorders
—
Diarrhea
Gastrointestinal disorders
—
HYDRONEPHROSIS
Renal and urinary disorders
—
Hematoma
Vascular disorders
—
Hematuria
Renal and urinary disorders
—
Hypotension
Vascular disorders
—
Sinus tachycardia
Cardiac disorders
—
Other adverse events (121 terms — click to expand)
This phase II trial studies olaparib and temozolomide in treating patients with uterine leiomyosarcoma (LMS) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that has spread from where it first started to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving olaparib and temozolomide may work better than giving either drug alone in treating patients with LMS.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer
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NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive
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NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant
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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
Other recruiting trials for Stage III Uterine Corpus Leiomyosarcoma AJCC v8
Currently open trials in the same condition.
NCT05432791 — Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped W
· Phase 2, PHASE3
· active not recruiting
NCT04200443 — Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcom
· Phase 2
· active not 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: 3 December 2025
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/NCT03880019.