A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer

Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:July 12, 2018
End Date:June 2021
Contact:Andreas Rimner, MD

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A Phase I Study of Olaparib and Low Dose Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer

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.

Inclusion Criteria:

- 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 by RECIST 1.1) at the completion of

- 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

- Adequate organ and marrow function, including:

1. Haemoglobin >/= 8.0 g/dL with no blood transfusion in the past 28 days.

2. Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L.

3. Platelet count >/= 100 x 10^9/L.

4. Total bilirubin
5. Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT))
/ Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT))
in which case they must be
6. Patients must have creatinine clearance estimated using the Cockcroft-Gault
equation of >/= 51 mL/min

- Patients must have a life expectancy >/= 16 weeks.

- Postmenopausal or evidence of non-childbearing status for women of childbearing
potential: negative serum pregnancy test within 28 days of study treatment and
confirmed prior to treatment on day 1.

a. Postmenopausal is defined as any one or more of the following: i. Age >/= 60 years.
ii. Age < 60 and amenorrheic for 1 year or more in the absence of chemotherapy and/or
hormonal treatment.

iii. Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post
menopausal range for women under 60.

iv. Radiation-induced oophorectomy with last menses >1 year ago v. Chemotherapy-induced
menopause with > 1 year interval since last menses. vi. Surgical sterilisation (bilateral
oophorectomy or hysterectomy).

- Men and women of childbearing potential must be willing to us two highly effective
forms of contraception while on treatment and for at least 3 months after last dose of
study drug.

- Patient is willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations.

- Written informed consent

Exclusion Criteria:

- Untreated brain metastases.

- 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.

- 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

- Major surgery within 2 weeks of study treatment initiation and patients must have
recovered from any effects of any major surgery.

- Patients considered a poor medical risk due to a serious, uncontrolled medical
disorder, non-malignant systemic disease or active/uncontrolled infection. Examples
include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3
months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal
cord compression, superior vena cava syndrome, extensive interstitial bilateral lung
disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder
that prohibits obtaining informed consent.

- Patients unable to swallow orally administered medication and patients with
gastrointestinal disorders likely to interfere with absorption of the study

- Breast feeding women.

- Immunocompromised patients, e.g., patients who are known to be serologically positive
for human immunodeficiency virus (HIV).

- Patients with a known hypersensitivity to olaparib or any of the excipients of the

- Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of
transmitting the infection through blood or other body fluids.

- Previous allogenic bone marrow transplant or double umbilical cord blood
transplantation (dUCBT).

- Whole blood transfusions in the last 120 days prior to entry to the study (packed red
blood cells and platelet transfusions are acceptable, for timing refer to inclusion
criteria number 8)

- Other malignancy within the last 5 years except: adequately treated non-melanomatous
skin cancer, curatively treated in situ cervical cancer, ductal carcinoma in situ
(DCIS), FIGO Grade 1 endometrial carcinoma, or other solid tumours including lymphomas
(without bone marrow involvement) curatively treated with no evidence of disease for
>/= 5 years. Patients with a history of localised triple negative breast cancer may be
eligible, provided they completed their adjuvant chemotherapy more than three years
prior to registration, and that the patient remains free of recurrent or metastatic

- Absence of brain metastases is not required. Patients must not have symptomatic brain
metastatic disease. The patient may be symptomatically controlled on a stable dose of
corticosteroids before and during the study as long as these were started at least 4
weeks prior to treatment.

- Patients with spinal cord compression unless considered to have received definitive
treatment for this and evidence of clinically stable disease for 28 days.
We found this trial at
225 Summit Avenue
Montvale, New Jersey 07645
Phone: 212-639-6025
Montvale, NJ
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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Basking Ridge, NJ
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Commack, New York 11725
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Commack, NY
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Harrison, New York
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Harrison, NY
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480 Red Hill Road
Middletown, New Jersey 07748
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Middletown, NJ
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1275 York Ave
New York, New York 10021
(212) 639-2000
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
New York, NY
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Rockville Centre, New York 11570
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Rockville Centre, NY
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Uniondale, New York 11553
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Uniondale, NY
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