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Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy

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ClinicalTrials.gov Identifier: NCT03140670
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
The main purpose of this study is to look at the effectiveness, safety, and antitumor activity (preventing growth of the tumor) of the experimental study drug rucaparib (also known as CO-338) on subjects and on their pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: RUCAPARIB Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open Label Study of Rucaparib in Patients With Advanced Pancreatic Cancer and a Known Deleterious Germline or Somatic BRCA or PALB2 Mutation
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rucaparib

Arm Intervention/treatment
Experimental: Single Arm Drug: RUCAPARIB
Rucaparib is a PARP inhibitor used as an anti-cancer agent. Rucaparib is a first-in-class pharmaceutical drug targeting the DNA repair enzyme poly-ADP ribose polymerase-1.




Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with locally advanced or metastatic disease
  • ≥18 years of age.
  • Eastern Cooperative Oncology (ECOG) performance status of 0 to 1.
  • Patients may have previously failed non-platinum containing therapy or may never have previously progressed on treatment.
  • Patients must be on treatment with platinum-based (cisplatin, oxaliplatin or carboplatin) treatment for locally advanced or metastatic pancreatic cancer and have received a minimum of 16 weeks of therapy without evidence of disease progression based on the investigator's opinion.
  • Discontinuation of the platinum component of the regimen for chemotherapy-related toxicity is permissible provided the patient has previously received at least 16 weeks of platinum-based therapy without evidence of disease progression ≤8 weeks after treatment with the platinum agent
  • Documented deleterious BRCA1/2 or PALB2 mutation (germline or somatic) as assessed by CLIA certified laboratory. Variants that are considered to be non-detrimental ("Variants of uncertain significance", "Variants of unknown significance", "Variant, favor polymorphism" or "benign polymorphism" etc) are not sufficient for study entry.
  • Measurable disease is not required for enrollment.
  • Adequate organ function confirmed by the following laboratory values obtained ≤7 days prior to the first day of rucaparib:

    1. Absolute neutrophil count (ANC) ≥1.5 x 109/L
    2. Platelets>100 x 109/L
    3. Hemoglobin≥9g/dL
    4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN)
    5. Total bilirubin ≤1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert's syndrome, then ≤2.5 x ULN.
    6. Serum creatinine ≤1.5 x ULN or estimated glomerular filtration rate (GFR) ≥45 mL/min using Cockcroft Gault formula.

Exclusion Criteria

  • Prior treatment with a PARP inhibitor
  • Patients who have demonstrated resistance to platinum agents (e.g. oxaliplatin, cisplatin) are not eligible to participate in this study
  • Clinical evidence of uncontrolled malabsorption and/or any other gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with the absorption of rucaparib
  • Acute infection requiring intravenous antibiotics, antiviral or antifungal agents during the 14 days prior to first dose of rucaparib
  • Symptomatic or untreated CNS metastases.
  • Expected life expectancy of <12 weeks as determined by the investigator.
  • For fertile patient (female able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial and for 6 months after the last dose of rucaparib.
  • Received any systemic treatment for pancreatic cancer ≤14 days prior to first dose of rucaparib.
  • Non-study related minor surgical procedure ≤5 days, or major surgical procedure ≤21 days, prior to the first dose of rucaparib; in all cases, patients must be sufficiently recovered and stable before treatment administration.
  • Active drug or alcohol use or dependence that would interfere with study compliance.
  • Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140670


Contacts
Contact: Colleen Redlinger 215-220-9693 colleen.redlinger@uphs.upenn.edu

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Colleen Redlinger    215-220-9693    colleen.redlinger@uphs.upenn.edu   
Principal Investigator: Kim Reiss Binder, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Kim Reiss Binder, MD Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03140670     History of Changes
Other Study ID Numbers: UPCC 05217
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents