A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer
A Phase I Study of Olaparib and Low Dose Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
1 other identifier
interventional
26
1 country
9
Brief Summary
The purpose of this study is to test the safety of a new medication, Olaparib, combined with radiation therapy for participants with small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2018
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2018
CompletedFirst Posted
Study publicly available on registry
May 22, 2018
CompletedStudy Start
First participant enrolled
July 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2025
CompletedFebruary 7, 2025
January 1, 2025
6.6 years
May 9, 2018
February 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum tolerated dose (MTD) of olaparib in combination with low dose thoracic radiotherapy
1 year
Safety of olaparib in combination with low dose thoracic radiotherapy by evaluating participant toxicities and adverse events
For safety, all adverse events as determined by the investigator using CTCAE
1 year
Study Arms (1)
Participants with Small Cell Lung Cancer
EXPERIMENTALInterventions
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)
The total prescribed dose will be 30 Gy in ten daily fractions of 3 Gy each delivered during business days over 2 calendar weeks.
Eligibility Criteria
You may qualify if:
- Histological documented diagnosis of SCLC confirmed by a MSKCC pathologist.
- Documented extensive disease, defined as any tumor beyond the above limited disease definition, including ipsilateral lung metastases and malignant pleural effusion
- Completion of induction chemotherapy with a minimum of 4 and no more than 6 cycles of a platinum agent and etoposide within 8 weeks of trial initiation.
- No disease progression (i.e.SD or better response per treating physician descretion) at the completion of chemotherapy.
- Age 18 years or older.
- Intrathoracic disease should be encompassable in acceptable radiation fields per investigator clinical judgement.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnosfsky Performance Score (KPS) \>/= 70
- Patients must have adequately recovered from any adverse events associated with prior immune-chemotherapy
- Adequate organ and marrow function, including:
- Haemoglobin \>/= 8.0 g/dL with no blood transfusion in the past 28 days.
- Absolute neutrophil count (ANC) \>/= 1.5 x 10\^9/L.
- Platelet count \>/= 100 x 10\^9/L.
- Total bilirubin \</= 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) \</= 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be \</= 5x ULN.
- Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of \>/= 51 mL/min
- +8 more criteria
You may not qualify if:
- Untreated brain metastases.
- Pneumonitis
- Previous radiotherapy to thorax (prior breast RT is permitted).
- Patient is not a candidate for or declines consolidative thoracic radiotherapy.
- Patients receiving any systemic chemotherapy or thoracic radiotherapy within 3 weeks prior to study treatment.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Previous enrolment in the present study.
- Exposure to an investigational product within 30 days or 5 half lives (whichever is longer) prior to start of the current study drug.
- Any previous treatment with PARP inhibitor, including olaparib, for the treatment of small cell lung cancer
- Resting ECG with QTc \> 470 msec on 2 or more time points within a 24 hour period or a documented family history of long QT syndrome.
- Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
- Concomitant use of known strong CYP3A inducers (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- For patients who have received prior immunotherapy, treatment must be held from 10 days prior to protocol treatment until 10 days after completing protocol treatment.
- Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
- Patients with myelodysplastic syndrome/acute leukaemia or with features suggestive thereof.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Baptist Alliance Miami Cancer Institute
Miami, Florida, 33143, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abraham Wu, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2018
First Posted
May 22, 2018
Study Start
July 12, 2018
Primary Completion
February 4, 2025
Study Completion
February 4, 2025
Last Updated
February 7, 2025
Record last verified: 2025-01