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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
Histological documented diagnosis of SCLC confirmed by a MSKCC pathologist
Documented extensive disease, including ipsilateral lung metastases and malignant pleural effusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Study 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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My small cell lung cancer diagnosis was confirmed by a specialist.
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My cancer has spread within my lung and to the surrounding fluid.
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I completed 4-6 cycles of specific chemotherapy within the last 8 weeks.
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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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My lung disease can be targeted with radiation according to my doctor.
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I am fully active or have some restrictions but can take care of myself.
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I have recovered from side effects of my previous cancer treatment.
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My blood tests, liver, and kidney functions are within normal ranges.
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I am postmenopausal or cannot become pregnant.
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I agree to use two effective birth control methods during and for 3 months after treatment.
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I am willing and able to follow the study's requirements, including treatments and check-ups.

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)

Awards & Highlights

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

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
1,920 Previous Clinical Trials
590,577 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

Frequently Asked Questions

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

What medical conditions are ameliorated by treatments involving radiotherapy?

"Radiotherapy is a viable form of treatment for advance directives, malignant neoplasms of the ovary, and primary peritoneal cancer."

Answered by AI

Is the research team currently enlisting participants for this experiment?

"This particular trial has ceased its recruitment efforts. Initially posted on 12th of July 2018, the study was last updated in September 2022. If you are seeking other trials to join, there are 1573 clinical studies actively enrolling patients with small cell lung carcinoma and 188 Radiotherapy related attempts which require volunteers."

Answered by AI

What is the current intake of individuals for this experiment?

"This clinical trial, posted on July 12th 2018 and last updated September 14th 2022, is no longer recruiting patients. If you are interested in similar investigations, there are 1,573 trials for small cell lung carcinoma that are currently enrolling participants as well as 188 radiotherapy studies actively recruiting."

Answered by AI

How many locations globally are partaking in this research?

"Nine medical centres are currently taking part in this trial, including Memorial Sloan Kettering Westchester located in Harrison and its two sister sites - the New york City-based Memorial Sloan Kettering Cancer Center and Commack's Memorial Sloan Kettering Commack. Additionally, 6 other treatment locations have also been recruited to take part."

Answered by AI

Has the FDA approved Radiotherapy as a viable remedy?

"Due to the initial stage of research, safety ratings for Radiotherapy were assigned a score of 1. This indicates that there is minimal data available attesting to its efficacy and security."

Answered by AI

Has there ever been a similar trial conducted before this one?

"Presently, 188 clinical trials concerning Radiotherapy are in progress across 1469 cities and 60 nations. The first study of its kind was performed by AstraZeneca in 2005 with the participation of 98 individuals; it concluded Phase 1 drug approval. Since then 205 further studies have been administered."

Answered by AI

Are there prior experiments that have employed Radiotherapy as a treatment?

"Presently, there are 188 ongoing studies that investigate the effectiveness of radiotherapy. 27 of these live trials have progressed to Phase 3. Most sites conducting this research can be found in Houston, Texas though a grand total 9255 locations are running clinical tests for Radiotherapy."

Answered by AI
~1 spots leftby Jun 2024