Olaparib in PALB2 Advanced Pancreatic Cancer

NCT06078787 | Recruiting Phase 2

• 1 other identifier: D0817L00067
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Pancreatic Cancer; Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2-3 years

Secondary Outcomes (5)

• To evaluate the PFS according to RECIST 1.1 following Olaparib administration

  2-3 years

• To evaluate the Incidence of Treatment-Emergent Adverse Events of Olaparib

  2-3 years

• To evaluate the DOR according to RECIST 1.1 following Olaparib

  2-3 years

• To evaluate the DRC according to RECIST 1.1 following Olaparib

  2-3 years

• To evaluate the OS according to RECIST 1.1 following Olaparib

  2-3 years

Study Arms (1)

Olaparb

EXPERIMENTAL

Drug: Olaparib 150 MG

Interventions

Olaparib 150 MG DRUG

Olaparib should be dosed 2 x 150 mg tablets (300 BID)

Olaparb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• \. 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
• 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.

You may not qualify if:

• 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.
• \. 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.
• \. 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.
• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

Aou Modena

Modena, 41125, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

LAURA CORTESI, MD

CONTACT

+390594224334; hbc@unimore.it

FEDERICA CAGGIA

CONTACT

0594223134; federica.caggia@unimore.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: October 12, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2026
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

IT (1)