Additional identifiers
EudraCT number
2010-021165-76
ClinicalTrials.gov number
Protocol/serial number
LU2006
Study information
Scientific title
Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial
Acronym
STOMP
Study hypothesis
The use of Olaparib as a maintenance therapy in patients with chemoresponsive small cell lung cancer (SCLC) prolongs the period of progression free survival beyond that of using a placebo.
Ethics approval
Added 08/10/2013: York and Humber Leeds East, 31/08/2011, ref: 11/YH/0290
Study design
Multicentre double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Small cell lung cancer
Intervention
Patients will be randomised to receive either Olaparib or placebo 200mg orally (per os [po]) twice a day (bis in die [bd]) for up to 2 years.
Intervention type
Drug
Phase
Phase II
Drug names
Olaparib (AZD2281)
Primary outcome measure
Current primary outcome as of 23/01/2019:
Progression-free survival time
Previous primary outcome:
Progression-free survival rate at 4 months from randomisation
Secondary outcome measures
Current secondary outcomes as of 23/01/2019:
1. Progression-free survival rate at 4 months from randomisation
2. Overall survival time
3. Overall survival rate at 6 months
4. Changes in performance status
5. Quality of life
6. Adverse events
7. Biomarkers: blood and biopsy samples will be collected for analysis of PARP and DNA repair pathways
Previous secondary outcomes:
1. Progression-free survival time
2. Overall survival time
3. Overall survival rate at 6 months
4. Changes in performance status
5. Quality of life
6. Adverse events
7. Biomarkers: blood and biopsy samples will be collected for analysis of PARP and DNA repair pathways
Overall trial start date
06/01/2011
Overall trial end date
19/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 23/01/2019:
1. Pathologically confirmed SCLC (limited or extensive stage)
2. Completed at least 3 cycles of first line chemotherapy or chemo-radiotherapy with cisplatin + etoposide or carboplatin + etoposide
3. Complete Response (CR) or Partial Response (PR) to first line chemotherapy (RECIST criteria)
4. ECOG performance status 0-2
5. Resolution of all treatment toxicity to grade 1 or better
6. Adequate physiological function:
6.1. Renal:
6.1.1. Calculated or measured creatinine clearance ≥ 50 ml/min
6.1.2. Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
6.2. Haematological:
6.2.1. Haemoglobin ≥ 9.0 g/dL
6.2.2. White blood cells (WBC) ≥ 3x109/L
6.2.3. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
6.2.4. Platelet count ≥ 100 x 109/L
6.2.5. International Normalized Ratio (INR) ≤ 1.2
6.3. Hepatic:
6.3.1. Aspartate Aminoransferase (AST)/ Alanine Aminotransferase (ALT) ≤ 2.5 x institutional ULN unless liver metastases are present in which case it must be ≤ 5x ULN
6.3.2. Bilirubin within normal range
7. Negative pregnancy test and agrees to comply with contraceptive measures
8. Provision of written informed consent
9. Able to swallow oral medication
10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
Previous inclusion criteria:
1. Pathologically confirmed SCLC (limited or extensive stage)
2. Completed at least 3 cycles of first line chemotherapy with cisplatin or carbopatin + etoposide
3. Complete Response (CR) or Partial Response (PR) to first line chemotherapy (RECIST criteria)
4. ECOG performance status 0-2
5. Resolution of all treatment toxicity to grade 1 or better
6. Adequate physiological function:
6.1. Renal:
6.1.1. Calculated or measured creatinine clearance ≥ 50 ml/min
6.1.2. Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
6.2. Haematological:
6.2.1. Haemoglobin ≥ 9.0 g/dL
6.2.2. White blood cells (WBC) ≥ 3x109/L
6.2.3. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
6.2.4. Platelet count ≥ 100 x 109/L
6.2.5. International Normalized Ratio (INR) ≤ 1.2
6.3. Hepatic:
6.3.1. Aspartate Aminoransferase (AST)/ Alanine Aminotransferase (ALT) ≤ 2.5 x institutional ULN unless liver metastases are present in which case it must be ≤ 5x ULN
6.3.2. Bilirubin within normal range
7. Negative pregnancy test and agrees to comply with contraceptive measures
8. Provision of written informed consent
9. Able to swallow oral medication
10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128
Participant exclusion criteria
Current exclusion criteria as of 23/01/2019:
1. Age ≤18 years
2. Interval from last anticancer treatment to start of study treatment:
2.1. Radiotherapy ≥ 21 days
2.2. Chemotherapy ≥ 42 days
3. Symptomatic brain metastases
4. Interstitial lung disease
5. Previous malignancies (except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or breast) within the past 3 years
6. History of malabsorption or major gastrointestinal tract resection likely to affect study drug absorption.
7. Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
8. Any previous treatment with a PARP inhibitor, including Olaparib
9. Patients receiving the following classes of inhibitors of CYP3A4; Azole antifungals; Macrolide antibioticsProtease inhibitors
10. 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, or any psychiatric disorder that prohibits obtaining informed consent.
11. Breast feeding women
12. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
13. Patients with known active hepatic disease (i.e., Hepatitis B or C)
14. Patients with a known hypersensitivity to Olaparib or any of the excipients of the product
15. Patients with uncontrolled seizures
16. Patients with myelodysplastic syndrome (MDS) / acute myeloid leukaemia (AML)
17. Major surgery within 14 days of starting trial treatment and patients must have recovered from any effects of any major surgery
Previous exclusion criteria:
1. Age ≤18 years
2. Interval from last anticancer treatment to start of study treatment:
2.1. Radiotherapy ≥ 21 days
2.2. Chemotherapy ≥ 42 days
3. Symptomatic brain metastases
4. Active infection on day of enrollment
5. Interstitial lung disease
6. Previous malignancies (except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or breast) within the past 3 years
7. History of malabsorption or major gastrointestinal tract resection likely to affect study drug absorption.
8. Treatment with any investigational product during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
9. Any previous treatment with a PARP inhibitor, including Olaparib
10. Patients receiving the following classes of inhibitors of CYP3A4; Azole antifungals; Macrolide antibioticsProtease inhibitors
11. 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, or any psychiatric disorder that prohibits obtaining informed consent.
12. Breast feeding women
13. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
14. Patients with known active hepatic disease (i.e., Hepatitis B or C)
15. Patients with a known hypersensitivity to Olaparib or any of the excipients of the product
16. Patients with uncontrolled seizures
Recruitment start date
06/01/2011
Recruitment end date
19/09/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Sheffield
Sheffield
S10 2SJ
United Kingdom
Funders
Funder type
Research council
Funder name
Clinical Trials Advisory and Awards Committee (CTAAC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AstraZeneca (UK)
Alternative name(s)
AstraZeneca PLC
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2017 abstract in https://doi.org/10.1016/j.jtho.2016.11.926 (added 23/01/2019)