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PARP Inhibitor

Olaparib + Temozolomide for Leiomyosarcoma

Phase 2
Waitlist Available
Led By Matthew Ingham
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be >= 18 years of age. Uterine LMS affects older adults and is rarely encountered in children and adolescents.
Patients must have histologically documented LMS of uterine origin. Pathology review and confirmation of diagnosis will occur at the site enrolling the patient on this study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying olaparib and temozolomide to see how well they work in treating patients with uterine leiomyosarcoma.

Who is the study for?
Adults with advanced uterine leiomyosarcoma that's spread or can't be surgically removed, who've had prior treatment failure or intolerance. Must be able to swallow pills, have adequate organ function, use effective contraception if needed, and agree to study procedures.Check my eligibility
What is being tested?
The trial tests a combination of Olaparib (a PARP inhibitor preventing tumor DNA repair) and Temozolomide (chemotherapy), aiming to see if they're more effective together against this cancer than when used separately.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver function alterations, and allergic reactions related to the drugs' components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My cancer is a type of uterine sarcoma confirmed by tissue analysis.
Select...
My advanced LMS has worsened or not tolerated previous treatment.
Select...
I am 18 years old or older.
Select...
My cancer cannot be removed by surgery and has spread.
Select...
I am not pregnant.
Select...
My cancer can be measured and safely biopsied according to specific guidelines.
Select...
My cancer is a type of uterine cancer confirmed by tissue analysis.
Select...
I am postmenopausal or cannot have children.
Select...
My hemoglobin level is at least 9 g/dL without recent blood transfusions.
Select...
My kidney function is normal or only mildly reduced.
Select...
I have LMS and it got worse or I couldn't tolerate at least one treatment.
Select...
I am using two reliable birth control methods if I can have children and am sexually active.
Select...
My cancer cannot be removed by surgery and has spread.
Select...
I can receive temozolomide as a standard treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I can take care of myself but might not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed Objective Response Rate (ORR) (Complete Response + Partial Response)
Secondary outcome measures
Number of Patients Experiencing Adverse Events
Progression-free Survival (PFS)
Proportion of MGMT Protein Expression in Uterine LMS Tumors
+2 more

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314
36%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Mucositis oral
9%
Vomiting
9%
Anemia
9%
Aspartate aminotransferase increased
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
White blood cell decreased
6%
Hypotension
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Anxiety
5%
Typhlitis
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Wound infection
3%
Lymphocyte count decreased
3%
Syncope
3%
Blood bilirubin increased
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Vulval infection
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Esophageal pain
1%
Heart failure
1%
Gastrointestinal disorders - Other, specify
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Menorrhagia
1%
Vascular disorders - Other, specify
1%
Anal hemorrhage
1%
Seizure
1%
Ascites
1%
Anal mucositis
1%
Tracheitis
1%
Vasovagal reaction
1%
Delirium
1%
Bone marrow hypocellular
1%
Sore throat
1%
Anaphylaxis
1%
Soft tissue infection
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib, temozolomide)Experimental Treatment5 Interventions
Patients receive olaparib PO BID and temozolomide PO QD on days 1-7 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI throughout the trial and undergo tumor biopsy at screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2790
Core Biopsy
2013
N/A
~130
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Olaparib
2007
Completed Phase 4
~2140
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,623 Total Patients Enrolled
4 Trials studying Uterine Leiomyosarcoma
271 Patients Enrolled for Uterine Leiomyosarcoma
Matthew InghamPrincipal InvestigatorYale University Cancer Center LAO
3 Previous Clinical Trials
263 Total Patients Enrolled
Brian Van TinePrincipal InvestigatorYale University Cancer Center LAO
2 Previous Clinical Trials
231 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03880019 — Phase 2
Uterine Leiomyosarcoma Research Study Groups: Treatment (olaparib, temozolomide)
Uterine Leiomyosarcoma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03880019 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03880019 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this type of clinical trial been done before?

"As of right now, 407 ongoing Temozolomide trials are taking place in 59 different nations and 1709 cities. The first-ever Temozolomide study was completed in 2002 by Schering-Plough. Only 60 patients were involved in the Phase 2 drug approval process. In the 19 years since that initial research project, 445 more studies have been conducted."

Answered by AI

Are there any other clinical trials that explore Temozolomide's effects?

"Currently, 407 studies are ongoing that involve Temozolomide. 52 of those live clinical trials are in Phase 3. Although the many trials for Temozolomide originated in Rochester, Minnesota, there are now 13,942 locations running studies for this treatment worldwide."

Answered by AI

Are we still recruiting volunteers for this research project?

"This study is not open for recruitment at the moment. The trial was first posted on June 7th, 2019 and was last updated on November 8th, 2022. There are presently 44 other studies actively recruiting participants with stage iva uterine corpus leiomyosarcoma ajcc v8 and 407 trials for Temozolomide that are looking for candidates."

Answered by AI

What health conditions does Temozolomide usually treat?

"Temozolomide is indicated for patients with advance directives. This medication can also help those who have received nitrosourea treatment, as well as those experiencing disease progression or chemotherapy resistance."

Answered by AI

What are some possible dangers associated with Temozolomide?

"Temozolomide is still in Phase 2 of clinical trials, so there is not yet enough evidence to support its efficacy. However, it has been shown to be safe and was given a score of 2."

Answered by AI

How many participants are being asked to join this clinical trial?

"As of now, this particular clinical trial is not looking for more participants. Although, it's worth mentioning that the trial was first posted on 6/7/2019 and last updated on 11/8/2022. If you're interested in other studies, there are currently 44 trials actively searching for patients with stage iva uterine corpus leiomyosarcoma ajcc v8 and 407 trials for Temozolomide admitting new participants."

Answered by AI

Are there many facilities conducting this research in North America?

"There are 15 sites conducting this trial, with locations in Gainesville, Aurora, Rochester and other cities. If you choose to participate in the trial, it is best to select the location nearest you to avoid any unnecessary travel."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Michigan
Arizona
How old are they?
65+
What site did they apply to?
Weisberg Cancer Treatment Center
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
0
~4 spots leftby Mar 2025