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Gastric AdenocarcinomaPhase 1NCT03244774

Phase I Study of the Combination of Apatinib and POF

A Phase 1 study testing Apatinib and POF in people with Gastric Adenocarcinoma, run by Fujian Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
Apatinib and POF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
1 Jan 2018to 30 Jun 2019
Phase
Phase 1
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

  • Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
  • No previous treatment with chemotherapy or radiation therapy.
  • Ability to take medications orally.
  • With or without measurable lesions.
  • Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
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  • Life expectancy ≥3 months.
  • With normal electrocardiogram results and no history of congestive heart failure.
  • Without bleeding and thrombosis disease.
  • With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
  • Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug
  • With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
  • With good compliance and agree to accept follow-up of disease progression and adverse events.

Who cannot join

  • Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
  • Patients with brain or central nervous system metastases, including leptomeningeal disease.
  • Pregnant (positive pregnancy test) or breast feeding.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
  • History of a stroke or CVA within 6 months.
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  • Clinically significant peripheral vascular disease.
  • Inability to comply with study and/or follow-up procedures.
  • Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.

Trial locations and contacts

1 site in 1 country.

Rongbo Lin contact

008613705919382

rongbo_lin@163.com

China1 site, 1 recruiting

  • Rongbo Lin

    Fuzhou, Fujian, 350014

    Rongbo Lin, MD, 86+13705919382, rongbo_lin@163.com

    Recruiting

Other trials in China

About this study

Official title: Phase I Study of the Combination of Apatinib and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)

In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators initialize this dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer. Investigators will analyze the maximum tolerated dose (MDT) and dose-limiting toxicity (DLT) of apatinib in this study.

Being tested
Apatinib, POF

What participants receive

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

  • ApatinibDrug

    Also called YN968D1

    Apatinib 250mg p.o. qd in first cohort (3 subjects). 375mg p.o. qd in second cohort (3 subjects). 500mg p.o. qd in third cohort (3 subjects). 625mg p.o. qd in forth cohort (3 subjects); 750mg p.o. qd in fifth cohort (3 subjects).

    Other Name:

  • POFDrug

    Also called Paclitaxel plus Oxaliplatin plus Luecovorin plus 5-Fluorouracil

    The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.

Study groups in NCT03244774
Study groupRoleWhat they receive
Apatinib plus POFExperimentalThis study will include a sequential evaluation of 3 subjects per cohort. Cohort 1: apatinib 250 mg per day and POF. Cohort 2: apatinib 375 mg per day and POF. Cohort 3: apatinib 500 mg per day and POF. Cohort 4: apatinib 625 mg per day and POF. Cohort 5: apatinib 750 mg per day and POF. A dose limiting toxicity (DLT) event is defined as any of the following events in the first 4-week period: 1. CTCAE Grade 4 event (except for neutropenia lasting for ≤ 5 days); 2. Grade 3 non-hematologic toxicity (except for nausea and vomiting that could be improved with optimal supportive care, escalation of alkaline phosphatase) If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If 2 DLTs are experienced in any cohort, the dose escalation ceased. The MTD was defined as the dose having at most two out of six patients experience DLT.
Receives: Drug: Apatinib; Drug: POF

What is being measured

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

  1. Dose limiting toxicity

    Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteria

    Measured: From enrollment to completion of study. Estimated about 12 months.

  2. Maximum tolerance dose

    Maximum tolerance dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DTL reported.

    Measured: From enrollment to completion of study. Estimated about 12 months.

Secondary outcomes (3)

  1. Objective response rate

    Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).

    Measured: From enrollment to 3 months after treatment

  2. Progression-free survival

    The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

    Measured: From enrollment to progression of disease. Estimated about 6 months.

  3. Overall survival

    The length of time from enrollment until the time of death (OS, overall survival).

    Measured: From enrollment to death of patients. Estimated about 1 year.

Timeline

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

  1. First posted10 Aug 2017
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 2018 (estimated)
  4. Study completion30 Jun 2019 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03244774
Sponsor's protocol ID
FNF 007
Status last verified
Jan 2018
First submitted
29 Jul 2017
Last updated
26 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apatinib and POF in people with Gastric Adenocarcinoma, run by Fujian Cancer Hospital 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 13 inclusion and 9 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 26 Jan 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Rongbo Lin (008613705919382, rongbo_lin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (time frame: From enrollment to completion of study. Estimated about 12 months.). 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 NCT03244774.

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 26 Jan 2018.

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