Malignant Solid TumorNCT02999750
EXtendedAnalysis for Cancer Treatment
A study testing individual therapy in people with Malignant Solid Tumor, run by Medical University of Vienna at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- individual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2013to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the detailed description
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
- Malignant Solid Tumor
- Being tested
- individual therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual therapyOther
Patient will be treated with individual therapy.
| Study group | Role | What they receive |
|---|---|---|
| individual therapy | Other | individual therapy Receives: Other: individual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald Prager, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999750
- Sponsor's protocol ID
- EXACT
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02999750
- Acronym / sponsor ID
- EXACT
- Conditions
- Malignant Solid Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Oct 2017 (estimated)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| individual therapy | Other | Other: individual therapyindividual therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individual therapyPatient will be treated with individual therapy. | Other | individual therapy |
Primary outcome
Use of real time biopsy to establish an individual molecular profile by using next generation sequencing
Time frame: 2 years
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual therapy in people with Malignant Solid Tumor, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of real time biopsy to establish an individual molecular profile by using next generation sequencing (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016; AzTrials last refreshed its copy on 30 Oct 2026.