AzTrials
AzTrials

Gastric CarcinomaPhase 2/3NCT00970138

Apatinib Versus Placebo as a Third Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

A Phase 2/3 study testing apatinib tablet in people with Gastric Carcinoma, run by Fudan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Carcinoma
What is being tested?
apatinib tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
141 participants
Where
1 siteChina
Study dates
Jun 2009to Dec 2010
Phase
Phase 2/3
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
  • Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
  • Have failed for 2 lines of chemotherapy
  • Life expectancy of more than 3 months
  • ECOG performance scale ≤ 2
  • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
Show all 10Show fewer
  • Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
  • More than 4 weeks for operation or radiotherapy
  • More than 4 weeks for cytotoxic agents or growth inhibitors
  • Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 × 109/L, neutrophil > 2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN).

Who cannot join

  • Pregnant or lactating women
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Any factors that influence the usage of oral administration; Evidence of CNS metastasis
  • History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
  • Receiving the therapy of thrombolysis or anticoagulation
Show all 10Show fewer
  • Abuse of alcohol or drugs
  • Allergy to the ingredient of the agent or more than two kinds of food and drug
  • Less than 4 weeks from the last clinical trial
  • Disability of serious uncontrolled intercurrence infection.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Randomized Phase 2/3 Study of Apatinib as Third Line Treatment in Patients With Metastatic Gastric Carcinoma

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Read the detailed description

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, the efficacy of these treatment is still unsatisfied for their toxicity and limitation in prolonging survival. Based on the promising results of apatinib in the phase I study, this clinical trial has been designed to evaluate whether apatinib can improve progression free survival in patients with metastatic gastric carcinoma who failed two lines of chemotherapy compared with placebo. Patients will be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg qd, one group patients will receive apatinib 425mg bid, and the other group will receive placebo.

Being tested
apatinib tablet
Keywords
Progress free survival, Toxicity, Response rate, Overall survival, Quality of live
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • apatinib tabletDrug

    A850: apatinib 850 mg qd p.o. plus placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

    B425: apatinib 425 mg bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

    Cpla: placebo bid p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

Study groups in NCT00970138
Study groupRoleWhat they receive
A 850Experimentalapatinib 850 mg qd, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: apatinib tablet
B 425Experimentalapatinib 425 mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: apatinib tablet
C plaPlacebo comparatorplacebo bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: apatinib tablet

What is being measured

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

  1. Progression free survival

    Measured: 8 weeks

Secondary outcomes (5)

  1. Overall survival safety

    Measured: 8 weeks

  2. DCR (Disease control rate)

    Measured: 8 weeks

  3. ORR (Objective response rate)

    Measured: 8 weeks

  4. QoL (Quality of life)

    Measured: 8 weeks

  5. Toxicity

    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 posted2 Sep 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionOct 2010
  4. Study completionDec 2010

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00970138
Sponsor's protocol ID
2009APA-MGC
Status last verified
Sep 2010
First submitted
1 Sep 2009
Last updated
12 Jul 2011
Results posted
No
Data monitoring committee
No

Publications

  • Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.

    PubMed 23918952

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing apatinib tablet in people with Gastric 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 10 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: finished, as of the sponsor's last update on 12 Jul 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 8 weeks). 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 NCT00970138, which also lists 1 linked publication.

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 12 Jul 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in