A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04425876
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 32.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer, and establish a maximum tolerated dose and recommended phase II dose of the combination and

1. assess the efficacy of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Fluzoparib	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 74 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study to Assess the Tolerability, Safety and Efficacy of Fluzoparib in Combination With mFOLFIRINOX as Neoadjuvant and Adjuvant Therapy in Patients With Resectable Pancreatic Cancer
• Actual Study Start Date: Dec 17, 2020
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluzoparib+mFOLFIRINOX Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy	Drug: Fluzoparib; Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy; Other Names: SHR3162

Outcome Measures

Primary Outcome Measures

1. Number of participants with a dose limited toxicity [28 Days (first and second cycle)]

   Number of participants with a dose limited toxicity

2. Maximum tolerated dose [Up to 8 months]

   Maximum tolerated dose

3. RP2D [Up to 8 months]

   Recommended Phase 2 Dose

4. R0 resection rate [Up to 2 years]

   R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer

Secondary Outcome Measures

1. AEs [From the first drug administration to within 30 days for the last drug dose]

   Incidence of adverse events and associated dose of Fluzoparib

2. Resection Rate [Up to 2 years]

   Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer

3. MPR Rate [Up to 2 years]

   Major pathological response rate based on central review

4. Objective response rate [Up to 2 years]

   Objective response rate

5. Disease-free-survival [Up to 2 years]

   Disease-free-survival

6. Event-Free-Survival [Up to 2 years]

   Event-Free-Survival

7. Overall-Survival [Up to 2 years]

   Overall-Survival

8. Minimum concentration (Cmin) [Up to 2 years]

   Minimum observed plasma concentration for Fluzoparib

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Aged 18-79 years.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1

• Expected survival ≥ 6 months.

• Histologically or cytologically confirmed pancreas adenocarcinoma.

• Resectable or borderline resectable pancreatic cancer.

• Adequate organ performance based on laboratory blood tests.

• Presence of at least of one measurable lesion in agreement to RECIST criteria.

• Ability to understand and the willingness to receive a needle biopsy.

• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients who have had any chemotherapy or radiotherapy prior to entering the study.

• Patients with metastasis disease.

• Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan, 5-Fluorouracil or other agents used in the study.

• Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks.

• Significant cardiovascular disease such as New York Heart Associate Class III/IV, cardiac failure, myocardial infarction, unstable arrhythmia, or evidence of ischemia on ECG within 6 months prior to enrolment.

• Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.

• Patients with myelodysplastic syndrome/acute myeloid leukaemia.

• Patients with second primary cancer except curatively treated in-situ cancer or slowly progressing malignancy.

• Known active hepatitis B or C infection.

• History of immunodeficiency (including HIV infection) or organ transplantation.

• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

• Principal Investigator: Boyong Shen, M.D., Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04425876
• Other Study ID Numbers: SHR3162-I-116
• First Posted: Jun 11, 2020
• Last Update Posted: Dec 31, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms

Study Results

No Results Posted as of Dec 31, 2020