A Phase II Clinical Trial of Fruquintinib as Third Line Treatment in Advanced Pancreatic Cancer

February 16, 2022 updated by: Weijian Guo, Fudan University

A Phase II Clinical Trial of the Safety and Efficacy of Fruquintinib in Advanced Pancreatic Cancer Patients Who Failed Second-line Gemcitabine or 5-FU Based Chemotherapy

A Phase II Clinical Trial of the Safety and Efficacy of Fruquintinib in Advanced Pancreatic Cancer Patients Who Failed Second-line Gemcitabine or 5-FU Based Chemotherapy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an open Label, non-randomized, single-arm and multi-centered phase II clinical trial. It plans to evaluate the safety and efficacy of fruquintinib in advanced pancreatic cancer patients who failed second-line gemcitabine or 5-FU based chemotherapy.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-80 years old;
  2. Locally advanced or recurrent/metastatic pancreatic adenocarcinoma confirmed by cytological or histopathological examination;
  3. Have failed second-line chemotherapy (gemcitabine or 5-FU-based regiments) (the definition of treatment failure is: toxic and side effects are intolerable, disease progression during treatment, recurrence within six months after the end of adjuvant chemotherapy, or progression within three months after the end of palliative chemotherapy); prior chemotherapy are required to include gemcitabine or 5-FU or its derivatives;
  4. With one or more measurable lesions, the longest diameter should be at least 10 mm measured by spiral CT scan, or at least 20 mm by conventional CT scan should be(RECIST standard, version 1.1);
  5. ECOG score was 0-2;
  6. Life expectancy ≥12 weeks;
  7. The damage was recovered from other antitumor treatments, including the interval from nitroso or mitomycin to enrollment was ≥6 weeks, and the interval from other cytotoxic drugs, radiotherapy or surgery to enrollment was ≥4 weeks, and the wound was completely healed;
  8. Acceptable hematologic, hepatic, and renal function within 7 days from screenin: absolute neutrophil count (ANC) ≥1.5x109 /L; Hemoglobin ≥ 9.0g/dL; Platelet count ≥80 x109 /L; Total bilirubin < 1.5 times upper limit of normal (ULN); ALT and AST< 2.5 x ULN (with liver metastasis <5x ULN); Serum creatinine ≤1 x ULN, endogenous creatinine clearance rate >50ml/min;
  9. Women of reproductive age need to take effective contraceptive measures;
  10. Participate in this study is voluntarily and sign informed consent. With good compliance to cooperate with the follow-up, participate should understand the purpose of this study and the necessary procedures.

Exclusion Criteria:

  1. A history of other malignant tumors in the past 5 year: however, localized tumor cured in the study is excluded, including cervical carcinoma in situ and skin basal cell carcinoma.
  2. Patients with hypertension that could not be controlled by antihypertensive drug therapy (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg), coronary heart disease of grade 1 or above, arrhythmia of grade 1 or above (including prolonged QTc interval > 450ms in males and > 470ms in females) and cardiac dysfunction of grade 1 or above;
  3. Symptomatic brain or meningeal metastases (except those with stable brain metastases for more than one month after treatment);
  4. Have a history of uncontrolled epileptic seizures, central nervous system dysfunction, or mental disorders;
  5. Uncontrolled pleural or abdominal effusion;
  6. Undergoing kidney dialysis;
  7. Severe or uncontrolled infection;
  8. With multiple factors affecting oral medication (inability to swallow, chronic diarrhea and intestinal obstruction);
  9. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg< 2g/L), bleeding tendency, receiving thrombolytic or anticoagulant treatment, and a history of thrombosis or embolism within six months;
  10. Patients at risk of gastrointestinal bleeding should not be enrolled, including: (1) patients with active digestive ulcer lesions and fecal occult blood (2+ or above); (2) patients with history of black stools and hematemesis within 3 months; (3) Patients with gastrointestinal fistula or perforation.
  11. Participated in other medicine clinical trials within four weeks.
  12. Weight less than 40kg.
  13. Urine protein ≥2+ by urine routine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Monotherapy of Fruquintinib
Drug: Fruquintinib
Fruquintinib 5mg qd, d1-21, q28d
Other Names:
  • F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival (PFS)
Time Frame: up to 24 months
The time from confirmation of enrollment to tumor progression or death from any cause, whichever came first
up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: through study completion, an average of 2 year
The proportion of patients whose tumors shrink to a certain extent and remain constant for a certain period of time
through study completion, an average of 2 year
overall survival (OS)
Time Frame: up to 36 months
The time from randomization to death from any cause, whichever came first
up to 36 months
disease control rate (DCR)
Time Frame: through study completion, an average of 2 year
percentage of cases with response to treatment (PR+CR) and disease stability (SD) that can be evaluated
through study completion, an average of 2 year
duration of response (DoR)
Time Frame: through study completion, an average of 2 year
the length of time that a tumor continues to respond to treatment without the cancer growing or spreading
through study completion, an average of 2 year
safety: the potential side effects
Time Frame: through study completion, an average of 2 year
the potential side effects
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Zhejiang Provincial People's Hospital

Investigators

  • Principal Investigator: Weijian Guo, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDZL-FPcT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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