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EXtendedAnalysis for Cancer Treatment

NCT ID: NCT02999750

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-10-31

Brief Summary

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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).

Detailed Description

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The treatment concept will be considered to be of clinical benefit for the individual patient if a progression-free survival (PFS) ratio (PFS on MP-based therapy / best PFS achieved by prior therapy) will be \> 1.0 thus generating a patient cohort with this very property. Thereby, the null hypothesis (that ≤ 40 % of this patient population would have a PFS ratio of \> 1.0) will be evaluated with each patient being his own control. For tumor types with high numbers of patients per cohort, the overall response rate (ORR) will be evaluated.

Conditions

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Malignant Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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individual therapy

individual therapy

Group Type OTHER

individual therapy

Intervention Type OTHER

Patient will be treated with individual therapy.

Interventions

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individual therapy

Patient will be treated with individual therapy.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerald Prager

Univ. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AKH Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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EXACT

Identifier Type: -

Identifier Source: org_study_id