Trial · NCT03880019
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
NCT03880019, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma. Trials, record NCT03880019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03880019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
- NCT number
- NCT03880019
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Stage III Uterine Corpus Leiomyosarcoma AJCC v8, Stage IV Uterine Corpus Leiomyosarcoma AJCC v8, Uterine Corpus Leiomyosarcoma
- Interventions
- Computed Tomography, Core Biopsy, Magnetic Resonance Imaging, Olaparib, Temozolomide
- First posted
- 2019-03-19
- Last updated
- 2026-07-31
- Results first posted
- 2023-09-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Objective Response Rate (ORR) (Complete Response + Partial Response) | 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 uterine leiomyosarcoma (LMS) treated with at least one prior systemic regimen. A response rate of 35% for the temozolomide (TMZ) + poly(adenosine diphosphate\[ADP\]-ribose) polymerase inhibitor (PARPi) combination would also be suggestive of superior efficacy over TMZ monotherapy in sarcoma. Will be reported with a 95% confidence interval. |
| Secondary | Number of Patients Experiencing Adverse Events | 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. |
| Secondary | Progression-free Survival (PFS) | Time from first treatment with the study drug to the earliest of either disease progression or death from any cause, assessed up to 2 years | The Kaplan-Meier method will be used to evaluate time to event endpoints. Median PFS will be reported with a 95% confidence interval. |
| Secondary | Proportion of Uterine LMS Tumors Exhibit Homologous Recombination (HR) Deficiency | Up to 2 years | Will be measured by genomic alterations in HR components at baseline and deoxyribonucleic acid (DNA) repair protein RAD51 homolog (RAD51) foci formation. The two integrated assays are genomics for alterations in HR genes and RAD51 foci formation. Both of these assays report binary results. The rate of response will be compared between binary variables using the Fisher's exact test. The log-rank test will be used to compare PFS between binary variables. Additional results from whole exome sequencing and ribonucleic acid sequencing (RNAseq) analysis on study samples will be reported in a descriptive fashion. |
| Secondary | Schlafen Family Member Number 11(SLFN11) Protein Expression | Up to 2 years | Will be assessed by immunohistochemistry (ICH). Macro ribonucleic acid (mRNA) expression may also be performed. Expression are reported as a continuous variable. Logistic regression will be used to estimate the odds of response for every unit increase in protein expression. Cox-regression will be used to evaluate the association between PFS and protein expression. Graphical displays such as box plots and Kaplan-Meier plots will be used to visualize the data. Evaluate for any association between presence of HR deficiency and increased clinical benefit from study treatment. |
| Secondary | Proportion of MGMT Protein Expression in Uterine LMS Tumors | Up to 2 years | Will be assessed by ICH. mRNA expression may also be performed. Expression are reported as a continuous variable. Logistic regression will be used to estimate the odds of response for every unit increase in protein expression. Cox-regression will be used to evaluate the association between PFS and protein expression. Graphical displays such as box plots and Kaplan-Meier plots will be used to visualize the data. Evaluate for any association between MGMT expression and increased clinical benefit from the study treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Objective Response Rate (ORR) (Complete Response + Partial Response) | Within first 6 months of study treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Experiencing Adverse Events | Up to 2 years after study treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) | Time from first treatment with the study drug to the earliest of either disease progression or death from any cause, assessed up to 2 years | |||
| SECONDARY | Proportion of Uterine LMS Tumors Exhibit Homologous Recombination (HR) Deficiency | Up to 2 years | |||
| SECONDARY | Schlafen Family Member Number 11(SLFN11) Protein Expression | Up to 2 years | |||
| SECONDARY | Proportion of MGMT Protein Expression in Uterine LMS Tumors | Up to 2 years |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Objective Response Rate (ORR) (Complete Response + Partial Response) | Treatment (Olaparib, Temozolomide) | 5 | Participants | ||
| Number of Patients Experiencing Adverse Events | Treatment (Olaparib, Temozolomide) | 20 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Olaparib, Temozolomide) | 23 | |
| Overall Study | COMPLETED | Treatment (Olaparib, Temozolomide) | 22 | |
| Overall Study | NOT COMPLETED | Treatment (Olaparib, Temozolomide) | 1 |
Source ClinicalTrials.gov
Adverse events136
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Olaparib, Temozolomide) | 6 | 22 | 26 |
| other | Abdominal tenderness near umbilicus | Gastrointestinal disorders | Treatment (Olaparib, Temozolomide) | 1 | 22 | 4 |
| other | Activated partial thromboplastin time prolonged | Investigations | Treatment (Olaparib, Temozolomide) | 1 | 22 | 8 |
| other | Alanine aminotransferase increased | Investigations | Treatment (Olaparib, Temozolomide) | 2 | 22 | 7 |
| other | Alkaline phosphatase increased | Investigations | Treatment (Olaparib, Temozolomide) | 5 | 22 | 24 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Treatment (Olaparib, Temozolomide) | 1 | 22 | 17 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Treatment (Olaparib, Temozolomide) | 1 | 22 | 21 |
| other | Anal fissure | Gastrointestinal disorders | Treatment (Olaparib, Temozolomide) | 1 | 22 | 18 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Olaparib, Temozolomide) | 16 | 22 | 188 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Olaparib, Temozolomide) | 6 | 22 | 22 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Olaparib, Temozolomide) | 8 | 22 |
| Total, other adverse events | Treatment (Olaparib, Temozolomide) | 22 | 22 |
| Total, serious adverse events | Treatment (Olaparib, Temozolomide) | 19 | 22 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186686 | NCI Experimental Therapeutics-Clinical Trials Network with Phase 1 Emphasis | ADJEI, ALEX A. | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 2014 to 2019 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03880019
GET https://conductscience.org/api/trials/v1/NCT03880019/events?page=2