Advanced Pancreatic CancerPhase 2PALBOLANCT06078787
Olaparib in PALB2 Advanced Pancreatic Cancer
A Phase 2 study testing Olaparib 150 MG in people with Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- Olaparib 150 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2023to 1 Aug 2026
- 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
- Has a histologically or cytologically confirmed pancreatic adenocarcinoma
- Has advanced (unresectable or metastatic) pancreatic cancer by American Joint Committee on Cancer 8th Edition
- Has documented mutation in PALB2 gene (germline or somatic) that is predicted to be deleterious or suspected deleterious.
- Has at least one lesion (measurable) that can be accurately assessed at baseline by CT scan (or MRI, if the subject is allergic to CT contrast media) and is suitable for repeated assessment according to RECIST Version 1.1 criteria.
- Has a life expectancy ≥16 weeks.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 3 days of the treatment initiation.
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- Has received at least one systemic treatment for advanced disease (locally advanced or metastatic disease).
- Has adequate organ function as defined in Table 2; all screening laboratory tests should be performed within 10 days prior to initiation of study intervention.
- Is male or female, who is at least 18 years of age at the time of signing the informed consent.
- Male Participants Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- A male participant must agree to use contraception ad detailed in Appendix D of this protocol during the treatment period and for at least 3 months following the last dose of Olaparib when having sexual intercourse with pregnant woman or with a WOPBP. Female partners of male patients should also use a highly effective form of contraception ([see appendix D for acceptable methods]) if they are of childbearing potential Male patients should not donate sperm throughout the period of taking olaparib and for 3 months following the last dose of olaparib.
- Female Participants Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- 11. A female participant is eligible to participate if she is not pregnant* (Appendix D), not breastfeeding and at least 1 of the following conditions applies:
- Not a WOCBP as defined in Appendix D
- OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix D during treatment period and for least one month after the last dose of study intervention.
- Postmenopausal is defined as:
- Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
- Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50
- radiation-induced oophorectomy with last menses >1 year ago
- chemotherapy-induced menopause with >1 year interval since last menses
- surgical sterilisation (bilateral oophorectomy or hysterectomy)
- evidence of non-childbearing status for women of childbearing potential is defined with negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1 (within 24 hours) and before every cycles.
- Informed Consent
- Has (or legally acceptable representative if applicable) provided written informed consent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main trial without participating in the FBR.
Who cannot join
- Has a known additional malignancy that is progressing or requires active treatment. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
- Has myelodysplastic syndrome/acute myeloid leukaemia or features suggestive of MDS/AML.
- 3. Patients with symptomatic uncontrolled brain metastases and/or carcinomatous meningitis. Subject with previously treated brain metastasis may participate proved they are stable (without evidence of progression by imaging for at leat four weeks prior to the first dose of trial treatment and any neurological symptoms have returned to baseline), no evidence of new or enlarging brain metastases. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
- 4. Has a documented weigh loss > 10% from baseline during screening and/or decline in ECOG PS to >1 between visit and within 73 hours prior to first dose of therapy.
- Has an active infection requiring systemic therapy.
- Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
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- Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia. Patients previously treated with Oxaliplatinum who experienced a ≤ G2 neuropathy can be included after consultation with the study physician
- Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
- Is unable to swallow orally administered medication or patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Is a immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Has a known active hepatitis (i.e. Hepatitis B or C).
- Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Prior/concomitant therapy
- Any previous treatment with PARP inhibitor, including Olaparib.
- Has prior systemic chemotherapy, targeted small molecule therapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
- Has received prior therapy with an anti-monoclonal antibody within 4 weeks or who has not recovered (i.e. <= G1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- 15. Bone as only site of metastatic disease from pancreatic cancer (bone only disease)
- 16. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- 17. Is currently receiving known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
- 18. Is currently receiving known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- 19. Has received previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- 20. Has received a whole blood transfusions in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable, if not performed within 28 days of the first dose of study intervention.
- Prior/concurrent clinical study experience
- 21. Patients that is currently participating or has participated in another clinical study with an investigational product administered in the last 4 weeks
- 22. Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- Diagnostic assessments
- 23. Has resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
- 24. Has a history or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Other exclusions
- Has a benign variant of PALB2 gene or variant of uncertain (or unknown) significance (VUS)
- Has a histology other than pancreatic adenocarcinoma (for example, neuroendocrine, adenosquamous etc.)
- Involvement in the planning and/or conduct of the study
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Is pregnant or breastfeeding,or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 30-90 days after the last dose of trial treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Multicentric Study of Olaparib in PALB2-related Advanced Pancreatic Cancer (PALBOLA)
This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.
Read the detailed description
This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.
After screening, 16 eligible participants with germline or somatic PALB2 mutations will be enrolled in this study. All participants will receive Olaparib 300 mg twice a daily (BID).
Study intervention will continue until documented PD, unacceptable AEs, intercurrent illness that prevents further administration of the study intervention, investigator's decision to discontinue the participant, participant withdrawal of consent, pregnancy of the participant, administrative reasons requiring cessation of study intervention.
After documented PD, each participant will be contacted by telephone every 12 weeks (+-14 days) to assess for survival status until withdrawal of consent to participate in the study, becoming lost to follow up, death or end of the study, whichever occurs first.
During treatment, efficacy will be evaluated using ORR, PFS, DOC and DCR using RECIST 1.1 Efficacy will also be evaluated by assessing OS. Participants will be evaluated with radiographic imaging to assess response to intervention at regular intervals throughout the study.
- Being tested
- Olaparib 150 MG
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaparib 150 MGDrug
Olaparib should be dosed 2 x 150 mg tablets (300 BID)
| Study group | Role | What they receive |
|---|---|---|
| Olaparb | Experimental | Not described Receives: Drug: Olaparib 150 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the ORR according to RECIST 1.1 following Olaparib administration
Objective response rate (ORR), defined as the percentage of patients with response of either Complete Response or Partial Response.
Measured: 2-3 years
Secondary outcomes (5)
To evaluate the PFS according to RECIST 1.1 following Olaparib administration
PFS, defined as the time from the date of the first dose until either disease progression or death due to any cause, whichever occurs first. .
Measured: 2-3 years
To evaluate the Incidence of Treatment-Emergent Adverse Events of Olaparib
measument of Adverse events (AEs)
Measured: 2-3 years
To evaluate the DOR according to RECIST 1.1 following Olaparib
DOR defined as the time from the date a response was first documented until either disease progression or death due to any cause, whichever occurs first.
Measured: 2-3 years
To evaluate the DRC according to RECIST 1.1 following Olaparib
DCR defined as the percentage of patients with ORR and stable disease
Measured: 2-3 years
To evaluate the OS according to RECIST 1.1 following Olaparib
OS definied as overall survival
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CORTESI LAURA, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078787
- Sponsor's protocol ID
- D0817L00067
- Acronym
- PALBOLA
- Status last verified
- May 2024
- First submitted
- 6 Jul 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicentric Study of Olaparib in PALB2-related Advanced Pancreatic Cancer (PALBOLA)
- ClinicalTrials.gov ID
- NCT06078787
- Acronym / sponsor ID
- PALBOLA / D0817L00067
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 12 Oct 2023 (actual)
- 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 Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.
Detailed description
This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.
After screening, 16 eligible participants with germline or somatic PALB2 mutations will be enrolled in this study. All participants will receive Olaparib 300 mg twice a daily (BID).
Study intervention will continue until documented PD, unacceptable AEs, intercurrent illness that prevents further administration of the study intervention, investigator's decision to discontinue the participant, participant withdrawal of consent, pregnancy of the participant, administrative reasons requiring cessation of study intervention.
After documented PD, each participant will be contacted by telephone every 12 weeks (+-14 days) to assess for survival status until withdrawal of consent to participate in the study, becoming lost to follow up, death or end of the study, whichever occurs first.
During treatment, efficacy will be evaluated using ORR, PFS, DOC and DCR using RECIST 1.1 Efficacy will also be evaluated by assessing OS. Participants will be evaluated with radiographic imaging to assess response to intervention at regular intervals throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olaparb | Experimental | Drug: Olaparib 150 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Has a histologically or cytologically confirmed pancreatic adenocarcinoma
- Has advanced (unresectable or metastatic) pancreatic cancer by American Joint Committee on Cancer 8th Edition
- Has documented mutation in PALB2 gene (germline or somatic) that is predicted to be deleterious or suspected deleterious.
- Has at least one lesion (measurable) that can be accurately assessed at baseline by CT scan (or MRI, if the subject is allergic to CT contrast media) and is suitable for repeated assessment according to RECIST Version 1.1 criteria.
- Has a life expectancy ≥16 weeks.
Key exclusion criteria (35 listed)
- Has a known additional malignancy that is progressing or requires active treatment. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
- Has myelodysplastic syndrome/acute myeloid leukaemia or features suggestive of MDS/AML.
- 3. Patients with symptomatic uncontrolled brain metastases and/or carcinomatous meningitis. Subject with previously treated brain metastasis may participate proved they are stable (without evidence of progression by imaging for at leat four weeks prior to the first dose of trial treatment and any neurological symptoms have returned to baseline), no evidence of new or enlarging brain metastases. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
- 4. Has a documented weigh loss > 10% from baseline during screening and/or decline in ECOG PS to >1 between visit and within 73 hours prior to first dose of therapy.
- Has an active infection requiring systemic 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 |
|---|---|---|
| Olaparib 150 MGOlaparib should be dosed 2 x 150 mg tablets (300 BID) | Drug | Olaparb |
Primary outcome
To evaluate the ORR according to RECIST 1.1 following Olaparib administration
Time frame: 2-3 years
Objective response rate (ORR), defined as the percentage of patients with response of either Complete Response or Partial Response.
5 secondary outcomes
To evaluate the PFS according to RECIST 1.1 following Olaparib administration
Time frame: 2-3 years
To evaluate the Incidence of Treatment-Emergent Adverse Events of Olaparib
Time frame: 2-3 years
To evaluate the DOR according to RECIST 1.1 following Olaparib
Time frame: 2-3 years
To evaluate the DRC according to RECIST 1.1 following Olaparib
Time frame: 2-3 years
To evaluate the OS according to RECIST 1.1 following Olaparib
Time frame: 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- 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.
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 150 MG in people with Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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 25 inclusion and 35 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 6 May 2024. 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 Italy. 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?
Contact LAURA CORTESI, MD (+390594224334, hbc@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the ORR according to RECIST 1.1 following Olaparib administration (time frame: 2-3 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 6 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.