STOMP: Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme
| ISRCTN | ISRCTN73164486 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73164486 |
| EudraCT/CTIS number | 2010-021165-76 |
| Secondary identifying numbers | LU2006 |
- Submission date
- 03/08/2010
- Registration date
- 13/09/2010
- Last edited
- 07/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Penella Woll
Scientific
Scientific
University of Sheffield
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
Study information
| Study design | Multicentre double-blind randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial |
| Study acronym | STOMP |
| Study objectives | 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(s) | Added 08/10/2013: York and Humber - Leeds East, 31/08/2011, ref: 11/YH/0290 |
| Health condition(s) or problem(s) studied | Small cell lung cancer |
| Intervention | Patients will be randomised to receive either olaparib or placebo 200 mg orally (per os [po]) twice a day (bis in die [bd]) for up to 2 years. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 06/01/2011 |
| Completion date | 19/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 128 |
| Total final enrolment | 220 |
| Key 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 Aminotransferase (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) ≥3 x 10e9/L 6.2.3. Absolute Neutrophil Count (ANC) ≥ 1.5 x 10e9/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 |
| Key exclusion criteria | Current exclusion criteria as of 23/01/2019: 1. Age ≤18 years 2. Interval from last anticancer treatment to the start of the 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 antibiotics; protease 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. Breastfeeding 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 the start of the study treatment: 2.1. Radiotherapy ≥21 days 2.2. Chemotherapy ≥42 days 3. Symptomatic brain metastases 4. Active infection on the 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 antibiotics; protease 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. Breastfeeding 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 |
| Date of first enrolment | 06/01/2011 |
| Date of final enrolment | 19/09/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Sheffield
Sheffield
S10 2SJ
United Kingdom
S10 2SJ
United Kingdom
Sponsor information
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research Department
11 Broomfield Lane
Sheffield
S10 2SE
England
United Kingdom
"ROR" |
https://ror.org/018hjpz25 |
|---|
Funders
Funder type
Research council
Clinical Trials Advisory and Awards Committee (CTAAC) (UK)
No information available
AstraZeneca (UK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | abstract | 01/01/2017 | 23/01/2019 | No | No |
| Basic results | version 1.0 | 08/12/2021 | 20/12/2021 | No | No |
| Results article | 15/07/2022 | 26/07/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Plain English results | 07/10/2024 | No | Yes |
Additional files
Editorial Notes
07/10/2024: Cancer Research UK plain English results added.
26/07/2022: Publication reference added.
20/12/2021: The following changes have been made:
1. The basic results of this trial have been uploaded as an additional file.
2. The total final enrolment number has been added.
15/10/2020: No publications found.
23/01/2019: The following changes have been made to the trial record:
1. Publication reference has been added
2. The participant inclusion criteria have been changed
3. The participant exclusion criteria have been changed
4. The primary outcome measure has been changed
5. The secondary outcome measures have been changed
09/11/2017: No publications found, verifying study status with principal investigator.
08/10/2013: The overall trial end date was changed from 06/01/2013 to 19/09/2015.
