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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
No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, olaparib and temozolomide, to treat advanced neuroendocrine cancers that have spread or can't be removed by surgery. Olaparib stops cancer cells from repairing themselves, while temozolomide kills them or stops their growth. The goal is to see if this combination works better than using temozolomide alone. Olaparib has shown activity in ovarian and other solid tumors, while temozolomide has been effective in treating various types of neuroendocrine tumors.

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.
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.
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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I do not have severe lung disease affecting both lungs.
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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 finished any cancer treatments or surgeries at least 28 days ago and have recovered.
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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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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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Incidence of adverse events
Objective response
Overall survival (OS)
Other study objectives
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%
Aspartate aminotransferase increased
9%
Mucositis oral
9%
Anemia
9%
Vomiting
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%
Hypotension
6%
White blood cell decreased
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%
Blood bilirubin increased
3%
Lymphocyte count decreased
3%
Syncope
3%
Wound infection
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Vulval infection
2%
Upper gastrointestinal hemorrhage
2%
Thromboembolic event
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%
Heart failure
1%
Ascites
1%
Vascular disorders - Other, specify
1%
Anal hemorrhage
1%
Penile pain
1%
Vasovagal reaction
1%
Gastrointestinal disorders - Other, specify
1%
Soft tissue infection
1%
Delirium
1%
Tracheitis
1%
Hepatobiliary disorders - Other, specify
1%
Seizure
1%
Esophageal pain
1%
Anal mucositis
1%
Menorrhagia
1%
Sore throat
1%
Bone marrow hypocellular
1%
Anaphylaxis
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2030
Olaparib
2007
Completed Phase 4
~2190
Temozolomide
2010
Completed Phase 3
~1880

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
Olaparib, a PARP inhibitor, works by preventing cancer cells from repairing their DNA, leading to cell death. Temozolomide, a chemotherapy drug, damages the DNA of cancer cells, stopping them from dividing and growing. For Pheochromocytoma patients, this combination is significant because it targets the cancer cells' ability to repair and proliferate, potentially reducing tumor growth and improving treatment efficacy.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,504 Total Patients Enrolled
3 Trials studying Adrenal Gland Pheochromocytoma
33,852 Patients Enrolled for Adrenal Gland Pheochromocytoma
Jaydira Del RiveroPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04394858 — Phase 2
Adrenal Gland Pheochromocytoma Research Study Groups: Arm II (temozolomide), Arm I (temozolomide, olaparib)
Adrenal Gland Pheochromocytoma 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
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