Appropriate Dosing to Optimise Personalised Cancer Treatments

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    25
  • sponsor
    University of Dundee
Updated on 25 January 2021
cancer
carcinoma
BRAF
KIT
advanced renal cell carcinoma
ovarian carcinoma
ovarian epithelial carcinoma
cancer of the ovary
lung carcinoma

Summary

This is a pilot study to assess feasibility of dried blood spot (DBS) samples for pharmacokinetic measurements of targeted anti-cancer drugs in oncology patients such as patients with BRAF-mutant melanoma receiving targeted treatment with BRAF and MEK inhibitors.

Description

In the pharmacology laboratory, we have developed a method for measuring drug concentrations in animals using dried blood spots (DBS). DBS is a simple method that could be easily carried out by patients at home, using either filter paper-based DBS cards (e.g. Whatman 903, FTA DMPK-C) or small sponges (www.neoteryx.com).

The routine use of DBS to clinically test blood was first used in the 1960s as a safe and simple method of testing for inherited metabolic disorders in new born babies. However, in recent years there has been increasing use of DBS to test blood for other things, including for drugs as a way to monitor the drug level in the blood.

This method has great potential application in testing blood for drug levels in cancer patients. We wish to establish if this DBS technique is feasible in real-life practice for cancer patients on targeted anti-cancer therapies as should this be the case this innovation could herald a new era in personalised treatment of advanced human cancers allowing doctors to more safely use combinations of targeted therapies. These combinations of targeted therapies have been shown to inhibit development of drug resistance and are increasingly being used in clinical practice. However, targeted therapies often fail (especially combinations of targeted therapies) because of unacceptable toxicities making them intolerable for the patient. With an easy and acceptable method for monitoring the drug level in blood, as could be provided by DBS, the right amount of drug could be given to each individual patient and this 'personalised' drug dosing as standard of care might result in much greater success with combinations of anti-cancer drugs.

This drug monitoring is especially important for targeted anti-cancer therapies because many of these (such as Dabrafenib, used for many cases of advanced melanoma) have profound affects on the liver enzymes that metabolise (get rid of) most medications. Dabrafenib is a potent inducer of P450 liver enzymes and this induction means that other drugs metabolised by the same liver pathway (the great majority of drugs are metabolised by the same pathways) will have significantly reduced blood levels if the patient is on Dabrafenib. So it is especially important to be able to monitor blood levels of both Dabrafenib and of other co-medications that the patient may be taking. The DBS sampling method would allow this and would provide a safe, convenient and cheap test that could be conducted in the patient's home and posted back to the laboratory.

Details
Condition Non-Small Cell Lung Cancer, Ovarian disorder, Ovarian Cancer, Metastatic Melanoma, Ovarian Function, Stage IV Renal Cell Cancer, Stage IV Melanoma, Stage III Melanoma, Recurrent Ovarian Cancer, Melanoma Stage III, Melanoma Stage Iv, Renal Cancer Stage III, Renal Cancer Stage IV, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, nsclc, ovarian tumors, stage iv kidney cancer
Treatment Venous blood sampling, Dried blood Spot (DBS)
Clinical Study IdentifierNCT04154163
SponsorUniversity of Dundee
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Melanoma Stage Iv or Renal Cancer Stage IV or Non-Small Cell Lung Cancer or Recurrent Ovarian Cancer or Ovarian Cancer or Ovarian Function or Renal Ca...?
Do you have any of these conditions: cancer of the ovary or ovarian tumors or Recurrent Ovarian Cancer or cancer, ovarian or nsclc or Stage IV Melanoma or Non-Small Cell Lung Cancer or Me...?
Male or female participants
Age 18 years and over
Confirmed diagnosis of stage 4 or stage 3 unresectable cancers; BRAF+ melanoma, c-KIT+ melanoma, advanced renal cell carcinoma, non-small cell lung carcinoma and ovarian carcinoma
Able to perform study assessments
Individuals who are participating in the follow-up phase of another interventional trial/study, or who are enrolled in an observational study, will be co-enrolled where the CIs of each study agree that it is appropriate

Exclusion Criteria

Inability to give informed consent
World Health Organisation (WHO) performance status 3-4
Known allergy or intolerance to Dabrafenib +/- Trametinib, Prazopanib, Erlotinib, Gefitinib, Imatinib, Osimertinib or Olaparib
Unstable co-morbidities; cardiovascular disease e.g. severe congestive cardiac failure, end stage renal failure, hepatic impairment, vasculopathy, inflammatory arthritis or interstitial lung disease/ pneumonitis which, in the opinion of the CI, would make the patient unsuitable to be enrolled in the study
Language barrier preventing adequate understanding of the study and a lack of suitable translator service to overcome this barrier
Pregnancy
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