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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.
Must not have
History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or TMZ
Concomitant use of known strong or moderate CYP3A inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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
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I am 18 years old or older.
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My cancer is a type of uterine sarcoma confirmed by tissue analysis.
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My advanced LMS has worsened or not tolerated previous treatment.
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I am 18 years old or older.
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My cancer cannot be removed by surgery and has spread.
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I am not pregnant.
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My cancer is a type of uterine cancer confirmed by tissue analysis.
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I am postmenopausal or cannot have children.
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My kidney function is normal or only mildly reduced.
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I am using two reliable birth control methods if I can have children and am sexually active.
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My cancer cannot be removed by surgery and has spread.
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I can receive temozolomide as a standard treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I can take care of myself but might not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to medications similar to olaparib or TMZ.
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I am not taking strong or moderate drugs that affect liver enzyme CYP3A.
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I am not taking any strong or moderate drugs that affect liver enzymes.
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I do not have any unmanaged ongoing illnesses.
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I do not have stomach or bowel problems affecting medicine absorption.
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I have not had major surgery in the last 2 weeks.
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My diagnosis is MDS, AML, or my tests show I might have these.
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I have not been treated with PARP inhibitors or drugs like dacarbazine/temozolomide.
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I currently have cancer that has spread to my brain or spinal cord.
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I have side effects from previous cancer treatments that are not severe.
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I had another cancer but have been free of it for 5 years or more.

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%
Anemia
9%
Aspartate aminotransferase increased
9%
Vomiting
9%
Mucositis oral
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%
Typhlitis
5%
Anxiety
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%
Syncope
3%
Lymphocyte count decreased
3%
Wound infection
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%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
2%
Thromboembolic event
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%
Anaphylaxis
1%
Soft tissue infection
1%
Ascites
1%
Vascular disorders - Other, specify
1%
Vasovagal reaction
1%
Esophageal pain
1%
Seizure
1%
Heart failure
1%
Penile pain
1%
Gastrointestinal disorders - Other, specify
1%
Bone marrow hypocellular
1%
Delirium
1%
Sore throat
1%
Tracheitis
1%
Menorrhagia
1%
Hepatobiliary disorders - Other, specify
1%
Anal mucositis
1%
Anal hemorrhage
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
~2720
Core Biopsy
2013
N/A
~130
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Olaparib
2007
Completed Phase 4
~2210
Temozolomide
2010
Completed Phase 3
~1930

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Uterine Leiomyosarcoma (LMS) include PARP inhibitors like Olaparib and chemotherapy agents like Temozolomide. Olaparib works by inhibiting the PARP enzyme, which is crucial for repairing DNA mutations in cancer cells, thereby leading to cell death. Temozolomide, on the other hand, damages the DNA of cancer cells, preventing them from dividing and spreading. This combination is significant for LMS patients as it targets the cancer cells through different mechanisms, potentially improving treatment efficacy and patient outcomes.
Integrating Precision Medicine into the Contemporary Management of Gynecologic Cancers.Treatment of Pediatric Glioblastoma with Combination Olaparib and Temozolomide Demonstrates 2-Year Durable Response.PARP Inhibition Elicits STING-Dependent Antitumor Immunity in Brca1-Deficient Ovarian Cancer.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,378 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
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