STOMP: Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme

Phase 2

Completed

• Conditions: Small cell lung cancer; Malignant neoplasm of lung; Cancer

• Registration Number: ISRCTN73164486
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Brief Summary

2017 Abstract results in https://doi.org/10.1016/j.jtho.2016.11.926 abstract (added 23/01/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35872530/ (added 26/07/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-13
• Study Completion: 2015-09-19
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified