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RUCAPARIB for Pancreatic Cancer

Phase 2

Waitlist Available

Led By Kim Reiss Binder, MD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing an experimental drug to see if it's effective, safe, and can prevent pancreatic cancer growth.

Eligible Conditions

Pancreatic Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS) at 6 Months (PFS6)

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response (DOR)

Overall Response Rate (ORR)

+2 more

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213

76%

Nausea

70%

Combined Asthenia/Fatigue

52%

Fatigue

39%

Combined Anaemia and/or decreased hemoglobin

38%

Constipation

38%

Vomiting

37%

Anaemia

35%

Diarrhoea

35%

Alanine aminotransferase increased

34%

Combined ALT/AST increased

33%

Abdominal pain

31%

Dysgeusia

29%

Combined Thrombocytopenia and/or decreased platelets

27%

Aspartate aminotransferase increased

25%

Decreased appetite

23%

Asthenia

22%

Arthralgia

20%

Headache

19%

Combined Neutropenia and/or decreased ANC

19%

Photosensitivity reaction

18%

Cough

17%

Thrombocytopenia

17%

Blood creatinine increased

16%

Dyspepsia

16%

Insomnia

16%

Dizziness

15%

Pruritus

15%

Rash

15%

Dyspnoea

15%

Abdominal pain upper

15%

Back pain

15%

Pyrexia

14%

Platelet count decreased

14%

Neutropenia

13%

Abdominal distension

13%

Upper respiratory tract infection

12%

Hypertension

12%

Oedema peripheral

12%

Hypomagnesaemia

10%

Nasopharyngitis

10%

Alopecia

10%

Taste disorder

10%

Dry skin

10%

Urinary tract infection

Mucosal inflammation

Influenza

Depression

Stomatitis

Erythema

Anxiety

Neutrophil count decreased

Hypercholesterolaemia

Dry mouth

Weight decreased

Myalgia

Oropharyngeal pain

White blood cell count decreased

Gastrooesophageal reflux disease

Influenza like illness

Hot flush

Neck pain

Pain in extremity

Blood alkaline phosphatase increased

Muscle spasms

Sinusitis

Combined Anemia and/or low hemoglobin

Incarcerated hernia

General physical health deterioration

Intestinal obstruction

Sepsis

Muscular weakness

Combined Thrombocytopenia and/or low platelets

Osteoarthritis

Gastrointestinal pain

Pulmonary embolism

Febrile neutropenia

Pancytopenia

Small intestinal obstruction

Dehydration

Combined Netropenia and/or low ANC

Malignant melanoma

Malignant neoplasm progression

Myelodysplastic syndrome

Seizure

Acute kidney injury

Renal failure

100%

80%

60%

40%

20%

Study treatment Arm

Rucaparib 600 mg Tablets

Placebo Tablets

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,649 Total Patients Enrolled

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

105,049 Total Patients Enrolled

Kim Reiss Binder, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine

2 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are willing to take part in this experiment?

"This particular clinical trial is no longer searching for new participants. The original posting was on June 30th, 2017 and the most recent edit was on November 10th, 2021. However, there are presently 726 other trials actively recruiting patients with cancer of the pancreas and 35 studies for RUCAPARIB that still need participants."

Answered by AI

Could you please explain the potential risks associated with RUCAPARIB?

"There is some clinical data supporting RUCAPARIB's safety, but none for efficacy, so it received a score of 2."

Answered by AI

Have other investigators looked into this sort of treatment before?

"At present, 35 clinical trials for RUCAPARIB are ongoing in 861 cities and 34 countries. The very first trial was conducted back in 2014 by Clovis Oncology, Inc. That original study completed its Phase 3 drug approval stage with 564 participants. In the years since 2014, an additional 15 studies have been completed."

Answered by AI

Are researchers actively working to enroll new participants for this trial?

"Currently, this study is not enrolling patients. Although the trial was first posted on June 30th, 2017 and last updated November 10th, 2021, there are 761 other clinical trials actively recruiting patients."

Answered by AI

Recent research and studies

brca1Journal

Phase II Study of Maintenance Rucaparib in Patients with Platinum-sensitive Advanced Pancreatic Cancer and a Pathogenic Germline or Somatic Variant in brca1, brca2, or palb2

Reiss, Kim A., Rosemarie Mick, Mark H. O'Hara, Ursina Teitelbaum, Thomas B. Karasic, Charles Schneider, Stacy Cowden, et al.. 2021. “Phase II Study of Maintenance Rucaparib in Patients with Platinum-sensitive Advanced Pancreatic Cancer and a Pathogenic Germline or Somatic Variant in brca1, brca2, or palb2”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.00003.

clinicaltrials.govStudy

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

2017. "Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03140670.