Condition category
Cancer
Date applied
03/08/2010
Date assigned
13/09/2010
Last edited
04/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Penella Woll

ORCID ID

Contact details

University of Sheffield
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom

Additional identifiers

EudraCT number

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.

On 08/10/2013, the anticipated end date was changed from 06/01/2013 to 19/09/2015.

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 below 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 measures

Progression free survival rate at 4 months from randomisation

Secondary outcome measures

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

Eligibility

Participant 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

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

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

Research Department
11 Broomfield Lane
Sheffield
S10 2SE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes