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PARP Inhibitor

Olaparib + Radiotherapy for Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Andreas Rimner, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postmenopausal or evidence of non-childbearing status for women of childbearing potential
Documented extensive disease, including ipsilateral lung metastases and malignant pleural effusion
Must not have
Untreated brain metastases
Pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing the safety of a new drug, Olaparib, given with radiation therapy to people with small cell lung cancer.

Who is the study for?
This trial is for adults with small cell lung cancer who've finished at least 4 cycles of specific chemotherapy without disease progression. They must be postmenopausal or not able to bear children, have a good performance status, and recovered from previous treatments. No recent investigational drugs, systemic chemo, or radiotherapy are allowed.Check my eligibility
What is being tested?
The study tests different doses of Olaparib pills (ranging from 50 mg to 300 mg) combined with low dose radiotherapy on patients with small cell lung cancer. The goal is to determine the safety and effectiveness of this combination treatment.See study design
What are the potential side effects?
Olaparib may cause side effects like nausea, vomiting, fatigue, anemia (low red blood cells), neutropenia (low white blood cells), thrombocytopenia (low platelets), indigestion, diarrhea, headache, taste changes and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am postmenopausal or cannot become pregnant.
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My cancer has spread within my lung and to the surrounding fluid.
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My cancer did not worsen after finishing chemotherapy.
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I am 18 years old or older.
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I am fully active or have some restrictions but can take care of myself.
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My small cell lung cancer diagnosis was confirmed by a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases that have not been treated.
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I have inflammation in my lungs.
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My heart's electrical activity is irregular, or I have a family history of long QT syndrome.
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I have lasting side effects from cancer treatment, but not hair loss.
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I do not have any serious, uncontrolled health issues or active infections.
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I haven't had chemotherapy or chest radiation in the last 3 weeks.
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I haven't taken any experimental drugs within the last 30 days or 5 half-lives.
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I am not taking strong or moderate CYP3A inhibitors.
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I have been diagnosed with myelodysplastic syndrome or acute leukemia.
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I cannot swallow pills or have stomach issues affecting medication absorption.
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I have had a bone marrow or double cord blood transplant.
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I do not have symptoms from brain metastases.
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I have been treated with a PARP inhibitor for small cell lung cancer.
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I am not undergoing or have chosen not to undergo chest radiation therapy.
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I have active hepatitis.
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I have not had major surgery in the last 2 weeks or have fully recovered from one.
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I haven't had any other cancer in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) of olaparib in combination with low dose thoracic radiotherapy
Safety of olaparib in combination with low dose thoracic radiotherapy by evaluating participant toxicities and adverse events

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Dysphagia-esophageal radiation
8%
Hypoglycemia
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Small Cell Lung CancerExperimental Treatment7 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,725 Total Patients Enrolled
Andreas Rimner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
386 Total Patients Enrolled
Abraham Wu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
68 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03532880 — Phase 1
Small Cell Lung Cancer Research Study Groups: Participants with Small Cell Lung Cancer
Small Cell Lung Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03532880 — Phase 1
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03532880 — Phase 1
~4 spots leftby Jul 2025
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