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Oesophageal CancerPhase 2SOLARNCT03829345

A Translational Study of Single Agent Olaparib in the Treatment of Advanced Oesophagogastric Cancer

A Phase 2 study testing Olaparib in people with Oesophageal Cancer and Gastro-Oesophageal Junction Cancer, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

SOlar is a multi-centre phase II clinical trial of single agent olaparib in advanced oesophagogastric cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Olaparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesUnited Kingdom
Study dates
2 Jul 2019to 14 Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced or metastatic oesophageal, gastro-oesophageal junction or gastric adenocarcinoma that has progressed during or within 6 months of first or subsequent line treatment
  • Patients with HER2-positive oesophageal, gastro-oesophageal, or gastric adenocarcinoma must have received previous treatment with trastuzumab
  • Male and female patients ≥18 years of age
  • Availability of tissue sample (resection or biopsy) confirming oesophageal, gastro-oesophageal junction, or gastric adenocarcinoma. If the patient does not have prior histological diagnosis, then the planned baseline fresh tumour biopsy may be used for both the purpose of confirming the histological diagnosis and subsequent biomarker analysis. All patients must be willing to have a fresh tumour biopsy to obtain tumour tissue for biomarker analysis at baseline and on progression
  • Disease amenable to safe biopsy
  • At least one lesion, not previously irradiated, that can be accurately measured as per RECIST criteria 1.1
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  • Able to give informed consent
  • Adequate organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below: Hb 10.0 g/dL independent of blood transfusions for 28 days, Absolute neutrophil count (ANC) 1.5 x 109/L, Platelet count ≥ 100 x 109/L, INR < 1.5, Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), AST/ ALT ≤ 2.5 x institutional ULN (unless liver metastases are present in which case it must be ≤ 5x ULN), Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) or a calculated creatinine clearance >51 mL/min for patients with creatinine levels above institutional normal. For GFR estimation, the Cockcroft and Gault equation should be used: GFR = CrCl (ml/min) = (140 - age [years]) × weight (kg) (xF)a /(serum creatinine [mg/dL]× 72)awhere F =0.85 for females and F=1 for males, Albumin >33 g/L
  • WHO ECOG performance status 0-1
  • Life expectancy of 16 weeks or more
  • Negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1) or postmenopausal status Postmenopausal status is defined as: Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments, LH and FSH levels in the postmenopausal range for women under 50, Radiation induced oophorectomy with last menses >1 year ago, Chemotherapy-induced menopause with >1 year interval since last menses, Or surgical sterilisation (bilateral oophorectomy or hysterectomy)
  • Patient is willing and able to comply with the protocol for the duration of the study including having examinations, undergoing treatment, and attending scheduled visits (including follow up)
  • Patients of child bearing potential and their partners, who are sexually active, must agree to the use of TWO acceptable effective birth control methods in combination throughout their participation in the study and for at least 1 month after the last dose of study drug. For example, condom with spermicide and oral contraceptive/hormonal therapy or condom with spermicide and placement of an intra-uterine device.

Who cannot join

  • Any previous treatment with a PARP inhibitor, including olaparib
  • Any second primary cancer (except adequately treated non-melanoma skin cancer, curatively treated cervical carcinoma-in-situ and curatively treated other solid tumours with no evidence of disease for 5 years or more)
  • Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons) or investigational product within 4 weeks from the last dose prior to starting treatment (or a longer period depending on the defined characteristics of the agents used). A stable dose of bisphosphonates is permitted for bone metastases before and during the study as long as they were started at least 4 weeks prior to starting treatment
  • Clinically significant heart disease such as uncontrolled symptomatic arrhythmias, congestive heart failure, or myocardial infarction within the previous 3 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
  • Interstitial pneumonia or symptomatic fibrosis of the lungs
  • Active brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with known brain metastases are eligible if they have been treated and there is no evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. Patients can take a stable dose of corticosteroids before and during the study as long as these were started 4 or more weeks prior to treatment
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  • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any previous major surgery
  • Pregnant and breastfeeding women
  • 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 major seizure disorder, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on 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 study medication absorption
  • Persistent toxicities (of CTCAE grade 2 or above) with the exception of alopecia, caused by previous cancer therapy
  • Immunocompromised patients e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV)
  • Patients with known active hepatic disease (i.e. Hepatitis B or C)
  • Patients with intestinal obstruction or patients with CTCAE grade ≥ 3 upper GI bleeding within 4 weeks of study entry
  • Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
  • Concomitant use of known strong (e.g. 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 study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents
  • 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
  • Resting ECG with QTc of over 500 msec on 2 or more time points within a 24 hour period or a family history of long QT syndrome.
  • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or features suggestive of MDS/AML
  • Patients with known hypersensitivity to olaparib or any of the excipients of the products
  • Vaccinated with live, attenuated vaccines within 4 weeks of enrolment
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)

Trial locations and contacts

2 sites in 1 country.

Claire Saffery contact

02086613637

claire.saffery@rmh.nhs.uk

United Kingdom2 sites, 2 recruiting

  • Claire Saffery

    Sutton, Surrey, SM2 5PT

    Claire Saffery, 02086613637, claire.saffery@rmh.nhs.uk

    Naureen Dr Starling

    Recruiting

  • Claire Saffery

    Sutton, SM2 5PT

    Claire Saffery, 02086613637, claire.saffery@rmh.nhs.uk

    Naureen Dr Starling

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Translational Phase II Study of Single Agent Olaparib in the Treatment of Advanced Oesophagogastric Cancer

SOlar is a multi-centre phase II clinical trial of single agent olaparib in advanced oesophagogastric cancer.

Read the detailed description

Gastric and oesophageal cancers are a significant health burden and are a leading cause of cancer related death. Despite improvements in survival over the last 4 decades overall the outcomes remain poor. In patients with advanced disease the outlook is particularly bleak with survival rates of less than one year with first line chemotherapy. New treatments are urgently needed to improve the poor survival rates in these cancers.

Olaparib is a PARP inhibitor which blocks poly(ADP-ribose) polymerase (PARP) 1, an enzyme which is involved in repair of damaged DNA. By inhibiting PARP1 olaparib prevents repair of damaged DNA. Cells with unrepaired DNA cannot survive and die.

This trial is designed to assess the efficacy and safety/tolerability of olaparib in patients with advanced oesophagogastric cancer. It will be conducted in two stages:

  • The first stage will evaluate the efficacy of olaparib in 27 patients. If 4 or fewer patients have control of their disease at 8 weeks then the trial for the olaparib arm will stop and no further patients will be recruited to the study. If 5-13 patients have control of their disease at 8 weeks then the study will progress to stage 2. If 14 or more patients have disease control at 8 weeks then a larger study may be opened in an unselected population.
  • The second stage will evaluate disease control in a further 27 patients. This is to allow identification of potential biomarkers of response.
Being tested
Olaparib
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Patients will be administered olaparib orally twice daily (BD) at 300mg continuously for each 28 day cycle.

Study groups in NCT03829345
Study groupRoleWhat they receive
OlaparaibExperimentalOlaparib will be given 300mg bd for a 28 day cycle.
Receives: Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Control Rate

    The primary endpoint is disease control rate (DCR) defined as stable disease, partial response or complete response according to RECIST 1.1 criteria.

    Measured: 8 weeks from initiation of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2019
  2. Study start2 Jul 2019
  3. Primary completion14 Feb 2021 (estimated)
  4. Study completion14 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03829345
Sponsor's protocol ID
CCR4825
Acronym
SOLAR
Status last verified
Jul 2019
First submitted
1 Feb 2019
Last updated
8 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib in people with Oesophageal Cancer and Gastro-Oesophageal Junction Cancer, run by Royal Marsden NHS Foundation Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Claire Saffery (02086613637, claire.saffery@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Control Rate (time frame: 8 weeks from initiation of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03829345.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.

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