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

NCT05257122 | Unknown Phase 2

• 1 other identifier: FDZL-FPcT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Pancreatic Carcinoma

Keywords

advanced pancreatic carcinoma; fruquintinib; target therapy

Outcome Measures

Primary Outcomes (1)

• progression free survival (PFS)

  The time from confirmation of enrollment to tumor progression or death from any cause, whichever came first

  up to 24 months

Secondary Outcomes (5)

• overall survival (OS)

  up to 36 months

• objective response rate (ORR)

  through study completion, an average of 2 year

• disease control rate (DCR)

  through study completion, an average of 2 year

• duration of response (DoR)

  through study completion, an average of 2 year

• safety: the potential side effects

  through study completion, an average of 2 year

Study Arms (1)

Arm A

EXPERIMENTAL

Monotherapy of Fruquintinib

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

Fruquintinib 5mg qd, d1-21, q28d

Also known as: F

Arm A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• Locally advanced or recurrent/metastatic pancreatic adenocarcinoma confirmed by cytological or histopathological examination;
• 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;
• 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);
• ECOG score was 0-2;
• Life expectancy ≥12 weeks;
• 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;
• 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;
• Women of reproductive age need to take effective contraceptive measures;
• 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.

You may not qualify if:

• 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.
• 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;
• Symptomatic brain or meningeal metastases (except those with stable brain metastases for more than one month after treatment);
• Have a history of uncontrolled epileptic seizures, central nervous system dysfunction, or mental disorders;
• Uncontrolled pleural or abdominal effusion;
• Undergoing kidney dialysis;
• Severe or uncontrolled infection;
• With multiple factors affecting oral medication (inability to swallow, chronic diarrhea and intestinal obstruction);
• 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;
• 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.
• Participated in other medicine clinical trials within four weeks.
• Weight less than 40kg.
• Urine protein ≥2+ by urine routine

Sponsors & Collaborators

• Fudan University: lead
• Zhejiang Provincial People's Hospital: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (4)

• Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Fan S, Hua Y, Su W. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018 Jun 26;319(24):2486-2496. doi: 10.1001/jama.2018.7855.

  PMID: 29946728 RESULT

• Martin LK, Li X, Kleiber B, Ellison EC, Bloomston M, Zalupski M, Bekaii-Saab TS. VEGF remains an interesting target in advanced pancreas cancer (APCA): results of a multi-institutional phase II study of bevacizumab, gemcitabine, and infusional 5-fluorouracil in patients with APCA. Ann Oncol. 2012 Nov;23(11):2812-2820. doi: 10.1093/annonc/mds134. Epub 2012 Jul 5.

  PMID: 22767582 RESULT

• Rougier P, Riess H, Manges R, Karasek P, Humblet Y, Barone C, Santoro A, Assadourian S, Hatteville L, Philip PA. Randomised, placebo-controlled, double-blind, parallel-group phase III study evaluating aflibercept in patients receiving first-line treatment with gemcitabine for metastatic pancreatic cancer. Eur J Cancer. 2013 Aug;49(12):2633-42. doi: 10.1016/j.ejca.2013.04.002. Epub 2013 Apr 30.

  PMID: 23642329 RESULT

• Cao J, Zhang J, Peng W, Chen Z, Fan S, Su W, Li K, Li J. A Phase I study of safety and pharmacokinetics of fruquintinib, a novel selective inhibitor of vascular endothelial growth factor receptor-1, -2, and -3 tyrosine kinases in Chinese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2016 Aug;78(2):259-69. doi: 10.1007/s00280-016-3069-8. Epub 2016 Jun 14.

  PMID: 27299749 RESULT

MeSH Terms

Interventions

HMPL-013

Study Officials

• Weijian Guo

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieyun Zhang

CONTACT

+8618801735823; Dr_JYZ@outlook.com

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: Proferssor

Model Details: This study is an open Label, non-randomized, single-arm and multi-centered phase II clinical trial.

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 25, 2022
• Study Start: February 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: February 1, 2024
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)