EXtendedAnalysis for Cancer Treatment

NCT02999750 | Unknown

• 1 other identifier: EXACT
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to prospectively validate treatment benefit of an individualized treatment concept based on molecular profiling (MP) from paraffin-embedded tumor tissue sections obtained before the start of treatment (real time biopsy).

Conditions

Malignant Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Use of real time biopsy to establish an individual molecular profile by using next generation sequencing

  pathological examination (includes genetic and target expression profiling, and drug sensitivity screening) to rank treatment options and the potential correlation between treatment response and progression free survival

  2 years

Study Arms (1)

individual therapy

OTHER

individual therapy

Other: individual therapy

Interventions

individual therapy OTHER

Patient will be treated with individual therapy.

individual therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

AKH Vienna

Vienna, Vienna, 1090, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr.

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 21, 2016
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: October 1, 2017
• Last Updated: December 21, 2016

Record last verified: 2016-12

Locations

AU (1)