Title

ATOM

Chief Investigator: 

Sponsor: University of Oxford

ClinicalTrials.gov Number: NCT02628080

 

Atovaquone as Tumour HypOxia Modifier

Full title: Pre-operative window of opportunity study of the effects of atovaquone on hypoxia in non-small cell lung carcinoma

 

STUDY DESIGN

Open label window of opportunity study

STUDY POPULATION

Patients with suspected non-small cell lung cancer (NSCLC)

STUDY STATUS

Open to recruitment

Target recruitment: 30 in total, 15 in cohort 1, 15 in cohort 2

Current Recruitment: 12 patients (Apr 2017)

Site - Churchill Hospital, Oxford University Hospitals Trust

STUDY SCHEMA

 

 

INCLUSION CRITERIA

  1. Suspected NSCLC considered suitable for surgical resection by the lung MDT.
  2. At least one measurable lesion (greater than 2.5cm maximal length in any direction) that the investigators consider on routine imaging (CT or PET-CT scan performed in the 60 days prior to consent (older scans may be accepted at the discretion of the CI providing the results remain clinically significant)) likely to contain regions of hypoxia.
  3. Male or female, Age > 18 years.
  4. ECOG performance score of 0-2
  5. The patient is willing and able to comply with the protocol, scheduled follow-up visits and examinations for the duration of the study.
  6. Written (signed and dated) informed consent.
  7. Haematological and biochemical indices within the ranges shown below:
Lab Test Value Required
Haemaglobin (Hb) ≥ 9.0 g/dL
Creatinine Below 2 x upper limit of normal
ALT and bilirubin Below 2.5 x upper limit of normal range

 

EXCLUSION CRITERIA

  1. Previous systemic chemotherapy or biological therapy within 21 days of commencing atovaquone treatment.
  2. Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to enrolment.
  3. Known previous adverse reaction to atovaquone or its excipients.
  4. Active hepatitis, gallbladder disease or pancreatitis
  5. Patients with impaired gastrointestinal (GI) function or GI disease that may significantly alter absorption of atovaquone.
  6. Concurrent administration of contraindicated agents in the 14 days prior to starting atovaquone as outlined in section 9.4 and the current atovaquone SmPC.
  7. Concurrent administration of warfarin in the 14 days prior to starting atovaquone.
  8. Patients taking known inhibitors of the electron transport chain such as Metformin.
  9. Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
  10. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV (Hepatitis and HIV testing specifically for confirming eligibility for this trial are not required).
  11. Pregnant or breast-feeding women or women of childbearing potential unless highly effective methods of contraception are used.

 

PRIMARY OBJECTIVE

  • To investigate whether atovaquone reduces tumour hypoxia.

SECONDARY OBJECTIVES

  • To further investigate whether atovaquone reduces tumour hypoxia.Late SBRT toxicity (>1 month to 6 months post-surgery)
  • To determine whether atovaquone results in a change in tumour perfusion.
  • To determine whether serological markers of hypoxia may replace hyp-PET-CT imaging in future studies of hypoxia modification.
  • To determine reproducibility of hyp-PET-CT, perfusion CT, serological tests, DWI-MRI and DCE-MRI

KEY DATES

Open to recruitment: 05 May 2016

Planned accrual completion: 31 October 2018

Trial duration: 30 Months

DATA SUBMISSION

Data submission for this trial is via electronic submission of data in OpenClinica

ATOM Trial Office (OCTO)

ATOM Trial Office: Tel: +44 (0)1865 617018

ATOM Registration Service Mon-Fri 9-5 (UK Time): UK Fax: +44(0)1865 617010

General Enquiries: Tel: +44 (0)1865 227 177

Fax: +44(0)1865 617010

Email: octo-ATOM@oncology.ox.ac.uk

Website: http://www.oncology.ox.ac.uk/research/oncology-clinical-trials-office-octo

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