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Pancreatic NeoplasmsPhase 2ApslpancNCT02726854

Apatinib as Second-line Treatment of Advanced Pancreatic Cancer

A Phase 2 study testing Apatinib in people with Pancreatic Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The main research purpose Evaluation of objective response Apatinib second-line treatment of advanced pancreatic cancer (ORR) and the rate of progression free survival (PFS). Objective to study the objective and exploratory secondary research To observe the Apatinib in second line treatment of advanced pancreatic… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Apr 2016to Dec 2017
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 and ≤ 70 years of age,Male or female;
  • The advanced pancreatic cancer pathology, with measurable lesions (spiral CT scan is more than 10mm, according to the standard of RECIST 1.1);
  • Locally advanced, unresectable recurrent or metastatic pancreatic cancer;
  • According to CTCAE 4.0 and patient complaints, the researchers determine second-line chemotherapy should not be tolerated by the patients or patients want to receive second-line chemotherapy.
  • ECOG performance scale 0-1;
  • Baseline blood routine and biochemical indexes meet the following criteria:
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  • Hemoglobin ≥ 80g/L,
  • The absolute neutrophil count (ANC) ≥ 1.5 ×109/L,
  • Blood platelet ≥ 90 ×109/L
  • Alanine aminotransferase(ALT),Aspartate transaminase (AST) less than 2.5 times the upper limit of normal value, equal to or less than 5 times the upper limit of normal (liver metastasis),
  • the serum total bilirubin is less than 1.5 times the upper limit of normal value,
  • Serum creatinine. Less than 1.5 times the upper limit of normal value,
  • Serum albumin is more than 30g/L;
  • Life expectancy ≥ 3 months.
  • women of childbearing age to within 7 days before entering the group of serum or urine pregnancy test and the results were negative. And be willing to give drug test during the test and the last 8 weeks using an appropriate method of contraception. For men, for sterilization, or agreed to during the period of the experiment and at the end of the given experimental drugs for 8 weeks by appropriate methods of contraception;
  • In this study, volunteer subjects signed the informed consent, good compliance with follow-up.

Who cannot join

  • It is confirmed that of apatinib and / or its accessories allergy;
  • Have high blood pressure and antihypertensive drug treatment can not drop to normal range(systolic pressure >140 mmHg, diastolic blood pressure 90>mmHg), suffering from coronary artery disease above grade I, grade I arrhythmia (including corrected QT interval prolongation male > 450 ms, women > 470 MS) and grade I heart insufficiency; urine protein positive patients.
  • Has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
  • Coagulant function abnormality (INR>1.5, activated partial thromboplastin time(APTT)>1.5, ULN) with bleeding tendency;
  • patients with central nervous system metastasis;
  • pregnant or lactating women;
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  • Patients with other malignant tumors within five years;
  • Has a history of psychiatric drugs abuse and can't quit or patients with mental disorders;
  • 4 weeks participated in other clinical trials of patients;
  • received VEGFR inhibitors, such as sorafenib, chougny for treatment;
  • According to the researcher's judgment, there is serious to endanger the safety of patients or affect patients with disease to do the research;
  • The researchers think that the person doesn't fit into.

Trial locations and contacts

1 site in 1 country.

Danfeng Dong, MD contact

008615349257340

qiwudanfeng@sina.com

China1 site, 1 recruiting

  • First affiliate hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    2982655038

    China, 2982655038

    Recruiting

Other trials in China

About this study

Official title: Apatinib as Second-line Treatment of Advanced Pancreatic Cancer, Phase II Clinical Study of Open Arm

The main research purpose Evaluation of objective response Apatinib second-line treatment of advanced pancreatic cancer (ORR) and the rate of progression free survival (PFS).

Objective to study the objective and exploratory secondary research To observe the Apatinib in second line treatment of advanced pancreatic cancer disease control rate (DCR), patients with overall survival (OS) benefit, treatment effects on quality of life (QOL) score and drug safety evaluation, To investigate the relationship of apatinib as second-line treatment of advanced pancreatic cancer and the expression of vascular endothelial growth factor receptor(VEGFR) in the serum

Read the detailed description

The purpose of this study is to determine what effects apatinib has on advanced pancreatic cancer patients after failure of first-line chemotherapy cannot tolerate second-line chemotherapy or unwilling to receive second-line chemotherapy of pancreatic cancer patients.To investigate the relationship between apatinib as second-line treatment of advanced pancreatic cancer and the expression of vascular endothelial growth factor receptor(VEGFR) in the serum.

This study choose the First Affiliated Hospital of Xi'an JiaoTong University were unable to tolerate the failure of first-line chemotherapy for second-line chemotherapy or unwilling to receive second-line chemotherapy of pancreatic cancer patients as the research object, the clinical data of clinical subjects age and sex, Eastern Cooperative Oncology Group （ECOG） score, tumor stage, pathological type, pathological grading, giving apatinib treatment, during the treatment of blood monitoring in patients with CA199 levels, imaging findings, assessment of tumor related symptoms and adverse events, and the expression of VEGFR in blood was measured by ELISA method, the curative effect evaluation of the end of the 2 cycle of treatment, patients with effective evaluation to oral apatinib, through the statistical analysis of the data of complete remission (CR) or partial remission (PR), the rate of progression free survival (PFS) expression of CA199 content in serum and serum VEGFR levels of the relevant indicators,. Explore Apatinib for the curative effect and safety of the second-line treatment of advanced pancreatic cancer, and to explore the relationship between the serum VEGF expression level.

Being tested
Apatinib
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • ApatinibDrug

    Also called YN968D1

    Patients with pancreatic cancer who are failed of receiving first-line chemotherapy and cannot tolerate second-line chemotherapy or unwilling to receive second-line chemotherapy will receive Apatinib Tablets (850mg once daily, orally) 30 minutes after meal with warm water. Take 28 days as a cycle, patients will receive this treatment until they have got disease progressed.

Study groups in NCT02726854
Study groupRoleWhat they receive
ApatinibExperimentalPatients will be offered with Apatinib (850mg daily,orally)until their disease have progressed.
Receives: Drug: Apatinib

What is being measured

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

  1. PFS(Progression free survival)

    Measured: 8 Weeks

  2. ORR (Objective response rate)

    Measured: 8 Weeks

Secondary outcomes (4)

  1. DCR(disease control rate)

    Measured: 8 Weeks

  2. OS (Overall survival)

    Measured: 8 Weeks

  3. QoL (Quality of life as assessed by EORTC QLQ-C30）

    Measured: 8 Weeks

  4. Number of participants with treatment-related adverse events as assessed by NCI-CTC（V3.0）

    Measured: 8 Weeks

Timeline

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

  1. First posted4 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (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
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02726854
Sponsor's protocol ID
XJTU1AF-CRF-2015-024
Acronym
Apslpanc
Status last verified
Nov 2016
First submitted
16 Mar 2016
Last updated
2 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Pancreatic Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong 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 16 inclusion and 12 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 2 Dec 2016. 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 Danfeng Dong, MD (008615349257340, qiwudanfeng@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS(Progression free survival) (time frame: 8 Weeks). The study lists 2 primary outcomes in all. 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 NCT02726854.

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 2 Dec 2016.

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