AdenocarcinomaPhase 2AVATARNCT02795650
Personalised Therapy for Metastatic ADPC Determined by Genetic Testing and Avatar Model Generation
A Phase 2 study testing Personalised treatment and Treatment chosen per investigator´s judge in people with Adenocarcinoma, run by Hospital Universitario de Fuenlabrada at 5 sites in Spain.
Trial summary
This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas. Patients randomised to the experimental arm will undergone tumoral biopsy before starting first line of treatment and will be administered personalised therapy as second or third line. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Personalised treatment and Treatment chosen per investigator´s judge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 5 sitesSpain
- Study dates
- May 2016to Sep 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas.
- ECOG performance status 0 or 1
- Age ≥ 18 years old.
- Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study.
- One or more sites of metastasis with one of the susceptible of biopsy.
- Measurable or evaluable disease
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- No prior treatment with radiotherapy, surgery, chemotherapy or investigational treatment for the metastatic disease or no more than the three cycles of first line chemotherapy. Palliative radiotherapy for bone metastasis is allowed. Adjuvant or neoadjuvant radiotherapy or chemotherapy are allowed if they finished more that 6 months ago and the patient has no remaining toxicities.
- Bone marrow function as follows, no more than 14 days prior to randomisation:
- ANC > 1,500 cells/mm3 Platelets > 100,000 cells/mm3 Hemoglobin ≥9 g/dl
- Adequate liver, renal and bone marrow functions.
- AST (SGOT), ALT (SGPT) ≤ 2.5 × ULN and ≤ 5 x ULN if liver metastases.
- Bilirubin ≤ 1,5 x ULN
- Albumin total ≥ 0,75 ULN
- Creatinine ≤ 1,5 x ULN
- Ability to sign informed consent
- Patients will be allowed to be randomised just once.
Who cannot join
- Brain metastases, unless they have been previously treated and stable for 3 months at least (defined as no oedema, no need of steroids and stable disease in two CT scans separated by a minimum of 4 weeks).
- Locally advanced disease.
- Malignancies other than pancreatic cancer diagnosed within 5 years prior to randomization, except for adequately treated carcinoma in situ or basal or squamous cell skin cancer.
- Bacterial, viral or fungal active infection that require systemic treatment.
- Any contraindication for tumor biopsy.
- Past or present HIV or hepatitis B or C infection.
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- Severe medical problems affecting organs or psychiatric illnesses that could interfere with the safety of the patient in the trial.
- Pregnancy or breastfeeding women.
- Patient will need to be informed and agree to undergo tumoral biopsy in the experimental arm.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario de la Paz
Madrid, 28046
Hospital Miguel Servet
Zaragoza, 50009
About this study
Official title: Personalised Therapy for Patients With Metastatic Adenocarcinoma of the Pancreas Determined by Genetic Testing and Avatar Model Generation
This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas. Patients randomised to the experimental arm will undergone tumoral biopsy before starting first line of treatment and will be administered personalised therapy as second or third line.
Read the detailed description
This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas.
Patients with metastatic disease will be randomised to the experimental or control arms. Those in the experimental arm will undergone a tumoral biopsy in order to perform exome sequencing, bioinformatic report, and avatar mouse models for drug testing. This information will allow the expertise panel to elaborate a treatment recommendation as second or third lines of treatment. Patients in the control arm will receive treatment as per investigator´s judge. The main objective of the trial is to determine whether personalised treatments achieve improved 1-year overall survival.
- Conditions
- Adenocarcinoma
- Being tested
- Personalised treatment, Treatment chosen per investigator´s judge
- Keywords
- Metastatic, Pancreas
- Medical subject headings
- Adenocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised treatmentDrug
Personalised treatments include chemotherapy, targeted therapy, immunotherapy or others based on the previous test results, chosen from a database that include more than 2000 different drugs.
Treatment chosen per investigator´s judgeDrug
Investigators are allowed to chose what they consider the best standard treatment option for their patients.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Personalised treatment will be chosen for patients based on the results of tumor sequencing, bioinformatics and avatar model drug testing. Receives: Drug: Personalised treatment |
| Control | Active comparator | Investigators are allowed to chose the best option of standard treatment for patients. Receives: Drug: Treatment chosen per investigator´s judge |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year overall survival
Efficacy. 1-year overall survival
Measured: 1-year overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Fuenlabrada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Hidalgo, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795650
- Sponsor's protocol ID
- 2015-004860-12
- Other IDs
- 2015
- Acronym
- AVATAR
- Status last verified
- Feb 2021
- First submitted
- 1 Jun 2016
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Huebner A, Black JRM, Sarno F, Pazo R, Juez I, Medina L, Garcia-Carbonero R, Guillen C, Feliu J, Alonso C, Arenillas C, Moreno-Cardenas AB, Verdaguer H, Macarulla T, Hidalgo M, McGranahan N, Toledo RA. ACT-Discover: identifying karyotype heterogeneity in pancreatic cancer evolution using ctDNA. Genome Med. 2023 Apr 20;15(1):27. doi: 10.1186/s13073-023-01171-w.
PubMed 37081523
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Therapy for Patients With Metastatic Adenocarcinoma of the Pancreas Determined by Genetic Testing and Avatar Model Generation
- ClinicalTrials.gov ID
- NCT02795650
- Acronym / sponsor ID
- AVATAR / 2015-004860-12
- Conditions
- Adenocarcinoma
- Keywords
- Metastatic, Pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Hospital Universitario de FuenlabradaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 10 Jun 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.
This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas. Patients randomised to the experimental arm will undergone tumoral biopsy before starting first line of treatment and will be administered personalised therapy as second or third line.
Detailed description
This is a multicenter, open label, randomised phase II clinical trial for patients with metastatic adenocarcinoma of the pancreas.
Patients with metastatic disease will be randomised to the experimental or control arms. Those in the experimental arm will undergone a tumoral biopsy in order to perform exome sequencing, bioinformatic report, and avatar mouse models for drug testing. This information will allow the expertise panel to elaborate a treatment recommendation as second or third lines of treatment. Patients in the control arm will receive treatment as per investigator´s judge. The main objective of the trial is to determine whether personalised treatments achieve improved 1-year overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Personalised treatmentPersonalised treatment will be chosen for patients based on the results of tumor sequencing, bioinformatics and avatar model drug testing. |
| Control | Active comparator | Drug: Treatment chosen per investigator´s judgeInvestigators are allowed to chose the best option of standard treatment for patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas.
- ECOG performance status 0 or 1
- Age ≥ 18 years old.
- Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study.
- One or more sites of metastasis with one of the susceptible of biopsy.
Key exclusion criteria (9 listed)
- Brain metastases, unless they have been previously treated and stable for 3 months at least (defined as no oedema, no need of steroids and stable disease in two CT scans separated by a minimum of 4 weeks).
- Locally advanced disease.
- Malignancies other than pancreatic cancer diagnosed within 5 years prior to randomization, except for adequately treated carcinoma in situ or basal or squamous cell skin cancer.
- Bacterial, viral or fungal active infection that require systemic treatment.
- Any contraindication for tumor biopsy.
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 |
|---|---|---|
| Personalised treatmentPersonalised treatments include chemotherapy, targeted therapy, immunotherapy or others based on the previous test results, chosen from a database that include more than 2000 different drugs. | Drug | Experimental arm |
| Treatment chosen per investigator´s judgeInvestigators are allowed to chose what they consider the best standard treatment option for their patients. | Drug | Control |
Primary outcome
1-year overall survival
Time frame: 1-year overall survival
Efficacy. 1-year overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Derived from this study: PubMed 37081523Huebner A, Black JRM, Sarno F, Pazo R, Juez I, Medina L, Garcia-Carbonero R, Guillen C, Feliu J, Alonso C, Arenillas C, Moreno-Cardenas AB, Verdaguer H, Macarulla T, Hidalgo M, McGranahan N, Toledo RA. ACT-Discover: identifying karyotype heterogeneity in pancreatic cancer evolution using ctDNA. Genome Med. 2023 Apr 20;15(1):27. doi: 10.1186/s13073-023-01171-w.
- Individual participant dataSharing planned: Undecided
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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.
Manuel Hidalgo, PhD principal investigator
Beth Israel Deaconess Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Personalised treatment and Treatment chosen per investigator´s judge in people with Adenocarcinoma, run by Hospital Universitario de Fuenlabrada at 5 sites in Spain.
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 16 inclusion and 9 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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
1-year overall survival (time frame: 1-year overall survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795650, which also lists 1 linked publication.
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 26 Feb 2021.