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Advanced Pancreatic CarcinomaPhase 2NCT05257122

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

A Phase 2 study testing Fruquintinib in people with Advanced Pancreatic Carcinoma, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Pancreatic Carcinoma
What is being tested?
Fruquintinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
Feb 2022to Feb 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 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;
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  • 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.

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

Jieyun Zhang contact

+8618801735823

Dr_JYZ@outlook.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Weijian Guo, PHD

Other trials in China

About this study

Official title: 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

Read the 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.

Being tested
Fruquintinib
Keywords
advanced pancreatic carcinoma, fruquintinib, target therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FruquintinibDrug

    Also called F

    Fruquintinib 5mg qd, d1-21, q28d

Study groups in NCT05257122
Study groupRoleWhat they receive
Arm AExperimentalMonotherapy of Fruquintinib
Receives: Drug: Fruquintinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival (PFS)

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

    Measured: up to 24 months

Secondary outcomes (5)

  1. overall survival (OS)

    The time from randomization to death from any cause, whichever came first

    Measured: up to 36 months

  2. objective response rate (ORR)

    The proportion of patients whose tumors shrink to a certain extent and remain constant for a certain period of time

    Measured: through study completion, an average of 2 year

  3. disease control rate (DCR)

    percentage of cases with response to treatment (PR+CR) and disease stability (SD) that can be evaluated

    Measured: through study completion, an average of 2 year

  4. duration of response (DoR)

    the length of time that a tumor continues to respond to treatment without the cancer growing or spreading

    Measured: through study completion, an average of 2 year

  5. safety: the potential side effects

    the potential side effects

    Measured: through study completion, an average of 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study startFeb 2022 (estimated)
  3. Primary completionSep 2023 (estimated)
  4. Study completionFeb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study is an open Label, non-randomized, single-arm and multi-centered phase II clinical trial.
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05257122
Sponsor's protocol ID
FDZL-FPcT
Status last verified
Feb 2022
First submitted
16 Feb 2022
Last updated
25 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29946728

  • 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.

    PubMed 22767582

  • 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.

    PubMed 23642329

  • 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.

    PubMed 27299749

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fruquintinib in people with Advanced Pancreatic Carcinoma, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jieyun Zhang (+8618801735823, Dr_JYZ@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (PFS) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05257122, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.

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