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Gastric CancerPhase 2NCT02501603

Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer

A Phase 2 study testing afatinib and paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Yonsei University at 1 site in South Korea.

Completed

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

Official record
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Trial summary

For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the transphosphorylation of ErbB3. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
afatinib and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteSouth Korea
Study dates
Jul 2016to 20 Dec 2022
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
  • EGFR 2+ or 3+ expression (immunohistochemistry)
  • ECOG performance status of 0 to 1
  • Male or female; ≥ 19 years of age
  • Documented disease progression after one prior therapy, in locally advanced or metastatic setting
  • patients received last adjuvant chemotherapy less than six months can be enrolled into this study
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  • Her2 positive patients must be progressed after prior trastuzumab based chemotherapy
  • Subjects with measurable lesion (using RECIST 1.1 criteria)
  • Subjects who meet the following criteria:
  • Absolute neutrophil count (ANC) ≥ 1000 /µL (*ANC = Neutrophil segs ＋ Neutrophil bands)
  • Platelet count ≥ 80,000/ µL
  • Serum creatinine < 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥50 mL/min using Cockcroft, Gault method
  • AST (SGOT) and ALT (SGPT) : 3 x upper limit of normal (ULN) (If there is Liver Metastasis : 5 x upper limit of normal (ULN))
  • Total bilirubin : 1.5 x upper limit of normal (ULN)
  • Provision of written informed consent prior to any study procedure

Who cannot join

  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
  • Any previous chemotherapy or immunotherapy within 2 weeks
  • Any major operation or irradiation within 4 weeks of baseline disease assessment
  • Two or more previous systemic cytotoxic chemotherapy (adjuvant chemotherapy is not counted)
  • Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
  • Previously taxol(paclitaxel)-exposed patients
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  • Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
  • Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
  • Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
  • Pregnant or lactating female
  • Patients with contraindicated medication
  • History of interstitial lung disease (ILD) or presence of ILD on chest X-ray
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital, Yonsei University Health System, Yonsei Cancer Center

    Seoul, 120-752

Other trials in South Korea

About this study

Official title: An Open-label, Multicenter Phase II Study of Afatinib Plus Weekly Taxol as Second Line Treatment for Advanced/Recurrent Gastric and Gastroesophageal Junction Cancer

For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for target enriched patients in gastric cancer.

Being tested
afatinib, paclitaxel
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • afatinibDrug

    Afatinib 40mg daily oral administration

  • paclitaxelDrug

    Paclitaxel 80mg/m2 IV weekly (day 1,8,15)

Study groups in NCT02501603
Study groupRoleWhat they receive
afatinib plus paclitaxelExperimentalafatinib plus paclitaxel
Receives: Drug: afatinib; Drug: paclitaxel

What is being measured

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

  1. compare progression free survival as measured by RECIST 1.1

    To identify antitumor activity of afatinib plus weekly taxol(paclitaxel) and explore predictive biomarker

    Measured: Every 6 weeks until progression, an expected average of 10 months

Secondary outcomes (2)

  1. antitumor efficacy as measured by RECIST 1.1

    Measured: every 6 weeks until progression, an expected average of 10 months

  2. safety as measured by CTCAE

    Measured: every 3 weeks until progression, an expected average of 10 months

Timeline

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

  1. First posted17 Jul 2015 (estimated)
  2. Study startJul 2016
  3. Primary completion31 Dec 2021
  4. Study completion20 Dec 2022

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
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02501603
Sponsor's protocol ID
4-2015-0244
Status last verified
Jan 2023
First submitted
8 Jul 2015
Last updated
27 Jan 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing afatinib and paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Yonsei University at 1 site in South Korea.

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 15 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: finished, as of the sponsor's last update on 27 Jan 2023. 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 South Korea. 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?

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?

compare progression free survival as measured by RECIST 1.1 (time frame: Every 6 weeks until progression, an expected average of 10 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 NCT02501603.

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 27 Jan 2023.

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