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PARP Inhibitor

Olaparib + Temozolomide for Neuroendocrine Cancer

Phase 2
Recruiting
Led By Jaydira Del Rivero
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
No prior treatment with temozolomide, dacarbazine, or a poly ADP ribose polymerase (PARP) inhibitor
No history of myelodysplastic syndrome (MDS) (or any dysplastic leukocyte morphology suggestive of MDS) or acute myeloid leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to the first documentation of disease progression (per response evaluation criteria in solid tumors [recist] version 1.1) or death, assessed up to 5 years
Awards & highlights

Study Summary

This trial is studying how well adding olaparib to temozolomide works in treating patients with neuroendocrine cancer.

Who is the study for?
Adults with advanced neuroendocrine cancer (pheochromocytoma or paraganglioma) that's spread or can't be surgically removed. Must not have had certain prior treatments, no known allergies to PARP inhibitors, and must agree to contraception. Pregnant/nursing women are excluded.Check my eligibility
What is being tested?
The trial is testing if adding Olaparib, a drug that prevents tumor cells from repairing DNA damage, to the usual chemotherapy Temozolomide helps more in treating advanced neuroendocrine cancers than chemotherapy alone.See study design
What are the potential side effects?
Olaparib may cause nausea, fatigue, blood cell count changes leading to infections or bleeding problems, and potential allergic reactions. Temozolomide can cause similar side effects including hair loss and constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not been treated with temozolomide, dacarbazine, or PARP inhibitors.
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I have never had myelodysplastic syndrome or acute myeloid leukemia.
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My bilirubin levels are normal, except for high levels due to Gilbert's syndrome.
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I do not have severe lung disease affecting both lungs.
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I do not have any stomach or intestine problems that affect medication absorption.
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My organs and bone marrow are functioning normally.
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I can swallow pills without any issues.
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My cancer can be measured and is at least 1 cm in size, or 1.5 cm if it's in the lymph nodes.
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My tumor is a confirmed advanced pheochromocytoma or paraganglioma that cannot be surgically removed.
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I have no allergies to PARP inhibitors or similar drugs.
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I have not had a bone marrow or cord blood transplant.
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I am not pregnant or breastfeeding and, if capable of bearing children, I have a recent negative pregnancy test.
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I will use protection during sex and avoid donating sperm while on the study drug and for 3 months after.
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I finished any cancer treatments or surgeries at least 28 days ago and have recovered.
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My heart condition is stable and I don't have long QT syndrome.
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I finished my antibiotics at least 7 days ago.
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My kidney function, measured by creatinine levels or clearance, is within the normal range.
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I do not have any current infections.
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My tumor is confirmed to be pheochromocytoma or paraganglioma.
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My scans show my cancer has grown in the last year.
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I have stopped taking certain strong medications that affect liver enzymes at least 21 days ago.
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I am 18 years old or older.
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I had MIBG therapy over 12 weeks ago and received less than 36 mCi/kg in total.
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My cancer has spread and cannot be removed by surgery.
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I am able to get out of my bed or chair and move around.
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I am not currently on combination antiretroviral therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to the first documentation of disease progression (per response evaluation criteria in solid tumors [recist] version 1.1) or death, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the first documentation of disease progression (per response evaluation criteria in solid tumors [recist] version 1.1) or death, assessed up to 5 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
Progression-free survival (PFS)
Secondary outcome measures
Incidence of adverse events
Objective response
Overall survival (OS)
Other outcome measures
Biochemical response
Biomolecular markers associated with clinical outcome

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%
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%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
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%
Gastrointestinal disorders - Other, specify
1%
Heart failure
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

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (temozolomide, olaparib)Experimental Treatment6 Interventions
Patients receive temozolomide PO QD and olaparib PO BID on days 1-7. Treatment with temozolomide repeats every 21 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Cycles of olaparib repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT with contrast or MRI throughout the study and undergo mandatory collection of blood samples prior to treatment. Patients may optionally undergo collection of blood samples at the time of progression.
Group II: Arm II (temozolomide)Active Control5 Interventions
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT with contrast or MRI throughout the study and undergo mandatory collection of blood samples prior to treatment. Patients may optionally undergo collection of blood samples at the time of progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Biospecimen Collection
2004
Completed Phase 2
~1920
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
13,626 Previous Clinical Trials
40,927,572 Total Patients Enrolled
14 Trials studying Paraganglioma
1,249 Patients Enrolled for Paraganglioma
Jaydira Del RiveroPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04394858 — Phase 2
Paraganglioma Research Study Groups: Arm II (temozolomide), Arm I (temozolomide, olaparib)
Paraganglioma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04394858 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04394858 — Phase 2

Frequently Asked Questions

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

Is this an innovative research project?

"Temozolomide research has been conducted since 2002, when the drug was sponsored by Schering-Plough. After a successful pilot study with 60 participants that same year, it received Phase 2 approval and is now being researched in 1707 cities across 59 nations - 386 studies are currently active."

Answered by AI

Could you elucidate the potential hazards of Temozolomide for patients?

"With Phase 2 clinical trials providing some evidence of safety but no data on efficacy, our team at Power assigned Temozolomide a score of 2."

Answered by AI

Have any past experiments incorporated Temozolomide?

"Presently, there are 386 ongoing trials investigating the efficacy of Temozolomide with 51 in late-stage development. Of these clinical sites, Phoenix Arizona holds a substantial number however 13805 other medical centres globally offer this research opportunity."

Answered by AI

What is the maximum capacity for recruitment into this trail?

"This medical investigation demands that 76 individuals, who meet the eligibility requirements, enroll. There are several sites allowing patients to join this trial including Memorial Sloan Kettering Basking Ridge in New jersey and Commack in New york."

Answered by AI

How many centers are actively administering this research?

"This particular clinical trial is being conducted at a total of 77 medical centres across the US, including but not limited to Memorial Sloan Kettering Basking Ridge in Basking Ridge, Memorial Sloan Kettering Commack in Commack and Memorial Sloan Kettering Bergen in Montvale."

Answered by AI

What diseases does Temozolomide typically target?

"Temozolomide is used to treat end-stage conditions such as relapse following chemo, progression of illness, and exposure to nitrosoureas."

Answered by AI

Is the recruitment phase of this research project still underway?

"That is correct - as of 11/2/2022, clinicaltrials.gov states that this medical research project is actively recruiting for 76 participants across 77 sites. The trial was initially posted on November 2nd 2020."

Answered by AI
~18 spots leftby Feb 2025