EXtendedAnalysis for Cancer Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02999750
• Date of registration: 07/12/2016
• Prospective Registration: No
• Primary sponsor: Medical University of Vienna
• Public title: EXtendedAnalysis for Cancer Treatment
• Scientific title: EXACT: EXtendedAnalysis for Cancer Treatment A Prospective Investigator-initiated Translational Study Evaluating Individualized Treatment Regiments Based on Respective Biomarker Analyses for Refractory Cancer Patients
• Date of first enrolment: October 2013
• Target sample size: 55
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02999750
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion Criteria:

Consenting patients of >19 years with advanced cancer fulfilling the criteria of having:

- an advanced malignancy with metastatic spread refractory to conventional treatment

- a life expectancy of >4 months,

- the possibility to access and biopsy tumour material within 4 weeks before onset of
individualized treatment,

- a malignancy amenable to further treatment options with either cytotoxic drugs,
tyrosine kinase inhibitors, monoclonal antibodies or related molecules with
anti-proliferative potential to cancer cells, as assessed by the ex vivo analysis and
a likelihood of treatment response according to the mathematical model (all outlined
in detail above),

- agreed to participate by their signature on an informed consent form are eligible.

Exclusion Criteria:

- Presence of further treatment options, as defined by NCCN guidelines which are
available in Austria representing a possible further treatment-related response by
conventional therapies according to generally accepted medical evidence.

- No fresh and viable tumor material available.

- Current use of therapeutic warfarin.

- Unresolved toxicity of National Cancer Institute Common Terminology Criteria for
Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous
anti-cancer therapy, except alopecia.

- Presence of active gastrointestinal disease or other condition that will interfere
significantly with the absorption of drugs.

- A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or
Hepatitis C Virus (HCV) infection.

- A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.

- History of other malignancy. Subjects who have been disease-free for 5 years or those
with a history of completely resected non-melanoma skin cancer or successfully
treated in situ carcinoma are eligible.

- Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc),
psychological, familial, sociological, or geographical conditions that do not permit
compliance with the protocol)

- unwillingness or inability to follow the procedures required in the protocol.

- pregnant or lactating females.

- History of alcohol or drug abuse within 6 months prior to screening.

- No informed consent available.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Malignant Solid Tumor

Intervention(s)

Other: individual therapy

Primary Outcome(s)

Use of real time biopsy to establish an individual molecular profile by using next generation sequencing [Time Frame: 2 years]

Secondary ID(s)

EXACT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors