Pancreatic CancerPhase 210NCT02511223
Efficacy and Safety of PARPi to Treat Pancreatic Cancer
A Phase 2 study testing OLAPARIB in people with Pancreatic Cancer, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This is an open label, single arm, phase II trial of Olaparib for (PDAC) pancreatic ductal adenocarcinoma patients with BRCAness (breast cancer gene). All study subjects will receive Olaparib in a dose of 300 mg p.o twice daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- OLAPARIB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to 18 Apr 2021
- 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
- • Patients must be male or female ≥18 years of age
- Patients with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
- Patients must have tested negative for BRCA 1 or 2 germline deleterious mutation or be ineligible for BRCA testing [as determined by their insurer]
- Patients with previously identified Loss of ATM by IHC OR
- Family history of BRCA-associated cancers: breast, ovarian, pancreatic, gastric or prostate must be present in 2 or more first-degree relatives OR
- Patients with previously identified genetic aberrations that are associated with HRD will be eligible [e.g. somatic BRCA mutation, Fanconi Anemia gene or RAD51 mutations].
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- Patients must have received at least one prior therapy for metastatic disease or have refused chemotherapy to be eligible
- Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in this study. RECIST 1.1 has been modified to allow the assessment of progression due to new lesions in patients with no evidence of disease at baseline
- (ECOG) Eastern Cooperative Oncology Group: A performance status using scales and criteria to assess how a patient's disease is progressing)Performance Status 0-1 (Karnofsky >70).
- Patients must have adequate organ and marrow function as defined below:
- Leukocytes >3,000 cells/mm3
- Absolute neutrophil count >1,500 cells/mm3
- Platelets >100,000 cells/mm3
- Hemoglobin >9 g/dl (no blood transfusions within 4 weeks prior to enrolment)
- Total bilirubin <1.5 X institutional upper limit of normal (IULN)
- (AST) aspartate aminotransferase (SGOT)/(ALT) Alanine transaminase(SGPT) <2.5 X IULN without liver metastasis <5 X IULN for patients with liver metastasis
- Creatinine within normal institutional limits OR
- Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- (INR)international normalized ratio <1.5
- Women of childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use adequate contraception for the duration of study participation. Male subjects must agree to refrain from sperm donation during the study and for 30 days after the last dose of study drugs.
- Ability to understand and the willingness to sign a written informed consent document. Signed informed consent form must be obtained prior to initiation of study evaluations and/or activities.
Who cannot join
- Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and myocardial infarction (MI) within 3 months of initiation of therapy.
- Pregnancy or lactation
- Patient has active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Patient has undergone major surgical resection within 4 weeks prior to enrollment.
- Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to study entry.
- Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug
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- Serious psychiatric or medical conditions that could interfere with treatment
- History of prior malignancy unless the malignancy has been treated with no evidence of active disease and more than 2 years from initial diagnosis
- Major bleeding in the last 4 weeks prior to study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PHASE II Study - EFFICACY AND SAFETY OF (PARPi )Polyadenosine Diphosphoribose [Poly Polymerisation inhibitorTO TREAT PANCREATIC CANCER
This is an open label, single arm, phase II trial of Olaparib for (PDAC) pancreatic ductal adenocarcinoma patients with BRCAness (breast cancer gene). All study subjects will receive Olaparib in a dose of 300 mg p.o twice daily. Treatment will continue until progression, intolerable toxicity or as per patient preference.
Primary objective:
To determine the efficacy of Olaparib monotherapy in stage IV pancreatic ductal adenocarcinoma (PDAC)with (BRCAness) BRCA -Breast Cancer susceptibility gene.
Read the detailed description
An open label, single arm, phase II trial of Olaparib for PDAC patients with BRCAness (BRCA-Breast Cancer susceptibility gene).
Patients with previously identified Loss of ATM (ATM serine/threonine kinase)by (IHC) Immunohistochemistry OR (overall survival) - Family history of BRCA (Brest Cancer gene)-associated cancers: breast, ovarian, pancreatic, gastric or prostate must be present in 2 or more first-degree relatives OR- Patients with previously identified genetic aberrations that are associated with (HRD) Homologous recombination deficiency will be eligible [e.g. somatic BRCA mutation, Fanconi Anemia gene or RAD51(eukaryote gene) mutations].
All patients will be retrospectively investigated for (HRD)Homologous recombination repair deficiencies signature using transcriptome profiling and ATM expression and the results correlated with (PARPi) (Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerization INHIBITOR) response rates.
Eligible patients will receive treatment with Olaparib tablets p.o 300 (mg) milligram twice daily until progression. Each treatment cycle is described as 28 days long. Patients will have tumor assessments according to RECIST 1.1(Response Evaluation Criteria In Solid Tumors) at baseline. Patients will then be followed for the final analysis of (OS) overall survival.
Eligible patients will be those patients with stage IV pancreas cancer previously treated for metastatic disease. Patients must have received one prior therapy for the treatment of metastatic disease or refused chemotherapy.
Following study entry, patients will attend clinic visits every two weeks for the first 4 weeks of treatment (Days 1 and 15,). Patients will then attend clinic visits every 4 weeks whilst on study treatment.
Patients should continue to receive study treatment until objective radiological disease progression as per RECIST as assessed by the investigator and as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.
Following discontinuation of study treatment, patients should be seen at 30 days post discontinuation for the evaluations outlined in the study schedule. Patients will be contacted in the 7 days following a specified date (data cut-off date) to capture survival status at that point for each survival analysis.
Patients will have tumor assessments according to RECIST at baseline and every 8 weeks (±1week) up to 40 weeks and then every 12 weeks (±1 week) relative to date of enrolment until objective radiological disease progression according to modified RECIST criteria. Ongoing collection of site review tumor assessment is required and must be recorded in the electronic case report form (eCRF).
Any patient who discontinues study treatment for reasons other than objective radiological progression should continue to undergo scheduled objective tumor assessments according to the study schedule, in order to assess objective radiological progression of disease. Failure to do so may result in bias to the study results.
- Conditions
- Pancreatic Cancer
- Being tested
- OLAPARIB
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLAPARIBDrug
Also called PARPi
Olaparib 300 (mg) twice a day per os given every day until disease progression or toxicity
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Only one Arm,All patients will receive Olaparib 300 (mg) milligram bid p.o till disease progression Receives: Drug: OLAPARIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) by using RECIST 1.1
Due to lack of results, study has been early terminated
Measured: approximately- 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJul 2016
- Primary completion18 Apr 2021
- Study completion18 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Talia Golan, MD, Principal investigator, Sheba Medical Centre, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511223
- Sponsor's protocol ID
- SHEBA-14-2358-TG-CTIL
- Acronym
- 10
- Status last verified
- Mar 2017
- First submitted
- 1 Jul 2015
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II Study - EFFICACY AND SAFETY OF (PARPi )Polyadenosine Diphosphoribose [Poly Polymerisation inhibitorTO TREAT PANCREATIC CANCER
- ClinicalTrials.gov ID
- NCT02511223
- Acronym / sponsor ID
- 10 / SHEBA-14-2358-TG-CTIL
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2016 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 18 Apr 2021 (actual)
- First posted
- 29 Jul 2015 (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 an open label, single arm, phase II trial of Olaparib for (PDAC) pancreatic ductal adenocarcinoma patients with BRCAness (breast cancer gene). All study subjects will receive Olaparib in a dose of 300 mg p.o twice daily. Treatment will continue until progression, intolerable toxicity or as per patient preference.
Primary objective:
To determine the efficacy of Olaparib monotherapy in stage IV pancreatic ductal adenocarcinoma (PDAC)with (BRCAness) BRCA -Breast Cancer susceptibility gene.
Detailed description
An open label, single arm, phase II trial of Olaparib for PDAC patients with BRCAness (BRCA-Breast Cancer susceptibility gene).
Patients with previously identified Loss of ATM (ATM serine/threonine kinase)by (IHC) Immunohistochemistry OR (overall survival) - Family history of BRCA (Brest Cancer gene)-associated cancers: breast, ovarian, pancreatic, gastric or prostate must be present in 2 or more first-degree relatives OR- Patients with previously identified genetic aberrations that are associated with (HRD) Homologous recombination deficiency will be eligible [e.g. somatic BRCA mutation, Fanconi Anemia gene or RAD51(eukaryote gene) mutations].
All patients will be retrospectively investigated for (HRD)Homologous recombination repair deficiencies signature using transcriptome profiling and ATM expression and the results correlated with (PARPi) (Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerization INHIBITOR) response rates.
Eligible patients will receive treatment with Olaparib tablets p.o 300 (mg) milligram twice daily until progression. Each treatment cycle is described as 28 days long. Patients will have tumor assessments according to RECIST 1.1(Response Evaluation Criteria In Solid Tumors) at baseline. Patients will then be followed for the final analysis of (OS) overall survival.
Eligible patients will be those patients with stage IV pancreas cancer previously treated for metastatic disease. Patients must have received one prior therapy for the treatment of metastatic disease or refused chemotherapy.
Following study entry, patients will attend clinic visits every two weeks for the first 4 weeks of treatment (Days 1 and 15,). Patients will then attend clinic visits every 4 weeks whilst on study treatment.
Patients should continue to receive study treatment until objective radiological disease progression as per RECIST as assessed by the investigator and as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.
Following discontinuation of study treatment, patients should be seen at 30 days post discontinuation for the evaluations outlined in the study schedule. Patients will be contacted in the 7 days following a specified date (data cut-off date) to capture survival status at that point for each survival analysis.
Patients will have tumor assessments according to RECIST at baseline and every 8 weeks (±1week) up to 40 weeks and then every 12 weeks (±1 week) relative to date of enrolment until objective radiological disease progression according to modified RECIST criteria. Ongoing collection of site review tumor assessment is required and must be recorded in the electronic case report form (eCRF).
Any patient who discontinues study treatment for reasons other than objective radiological progression should continue to undergo scheduled objective tumor assessments according to the study schedule, in order to assess objective radiological progression of disease. Failure to do so may result in bias to the study results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: OLAPARIBOnly one Arm,All patients will receive Olaparib 300 (mg) milligram bid p.o till disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- • Patients must be male or female ≥18 years of age
- Leukocytes >3,000 cells/mm3
- Absolute neutrophil count >1,500 cells/mm3
- Platelets >100,000 cells/mm3
- Hemoglobin >9 g/dl (no blood transfusions within 4 weeks prior to enrolment)
Key exclusion criteria (9 listed)
- Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and myocardial infarction (MI) within 3 months of initiation of therapy.
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 |
|---|---|---|
| OLAPARIBAlso: PARPiOlaparib 300 (mg) twice a day per os given every day until disease progression or toxicity | Drug | Single Arm |
Primary outcome
Objective Response Rate (ORR) by using RECIST 1.1
Time frame: approximately- 24 months
Due to lack of results, study has been early terminated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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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.
Talia Golan, MD principal investigator
Sheba Medical Centre, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OLAPARIB in people with Pancreatic Cancer, run by Sheba Medical Center at 1 site in Israel.
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 21 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: finished, as of the sponsor's last update on 19 Apr 2023. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective Response Rate (ORR) by using RECIST 1.1 (time frame: approximately- 24 months). 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 19 Apr 2023.