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Recurrent/Metastatic Gastric CancerPhase 1/2NCT04888663

Study of Ramucirumab, Trastuzumab and Paclitaxel in Patients With HER2-positive Recurrent/Metastatic Gastric Cancer (HER-RAM Study)

A Phase 1/2 study testing Trastuzumab + Ramucirumab + Paclitaxel in people with Recurrent/Metastatic Gastric Cancer, run by Yonsei University at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Human epidermal growth factor receptor 2 (HER2) is overexpressed or amplified in 10-20% of gastric or gastroesophageal junction cancer. Trastuzumab combined with fluorouracil and platinum has been established as first-line treatment for patients with HER2-positive gastric cancer. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Recurrent/Metastatic Gastric Cancer
What is being tested?
Trastuzumab + Ramucirumab + Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSouth Korea
Study dates
13 Feb 2018to 2 Sep 2021
Phase
Phase 1/2
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 proven metastatic or locally advanced HER2-positive gastric cancer
  • Documented disease progression after receiving prior line of trastuzumab-containing chemotherapy for gastric cancer
  • Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
  • Eligible male and female subjects aged ≥19 years.
  • Has measurable disease as determined by RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
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  • Has baseline left ventricular ejection fraction (LVEF) ≥ 55%.
  • Adequate organ function as demonstrated by laboratory test results within 14 days prior to first dose of study treatment.
  • Have urinary protein that is <2 on dipstick or routine urinalysis.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to first dose of study treatment.
  • Female subjects of childbearing potential and male subjects should be willing to use methods of birth control for the course of the study and up to 120 days after the last dose of study treatment.

Who cannot join

  • Received prior anticancer treatment with targeted agents, chemotherapy, or radiotherapy within 14 days, with monoclonal antibodies within 28 days, has previously received treatment with ramucirumab, or has participated in another clinical trial within 14 days prior to start of study treatment.
  • Has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to treatment.
  • Has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 3 months prior to treatment.
  • Has history of severe thromboembolism, including deep vein thrombosis and pulmonary embolism within 6 months prior to treatment.
  • Has an active or ongoing infection, symptomatic congestive heart failure, uncontrolled angina pectoris, symptomatic or poorly controlled arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.
  • Has ongoing or active psychiatric illness or social situation that would limit compliance with study requirements.
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  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has evidence of active, non-infectious pneumonitis.
  • Has a known history of Human Immunodeficiency Virus (HIV).
  • Has known active hepatitis B or hepatitis C.
  • Have an elective or a planned major surgery during the course of the trial or has undergone major surgery within 4 weeks prior to enrollment.
  • Has history of GI perforation and/or fistula within 6 months prior to treatment.
  • Is pregnant or breastfeeding, or possibly pregnant.
  • Has history of Child-Pugh Class B or more of liver cirrhosis or hepatic encephalopathy, or cirrhosis with clinically meaningful ascites.
  • Is undergoing long-term antiplatelet therapy within 7 days prior to treatment.
  • Has known history of hypersensitivity to one or more of the study treatments or their substances, or known severe hypersensitivity to monoclonal antibodies.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Health System, Severance Hospital

    Seoul, Seodaemun-gu, 03722

Other trials in South Korea

About this study

Official title: An Open-label, Multicenter Phase Ib/II Study of Ramucirumab in Combination With Trastuzumab and Weekly Paclitaxel in Patients With HER2-positive Recurrent/Metastatic Gastric Cancer

Human epidermal growth factor receptor 2 (HER2) is overexpressed or amplified in 10-20% of gastric or gastroesophageal junction cancer. Trastuzumab combined with fluorouracil and platinum has been established as first-line treatment for patients with HER2-positive gastric cancer. The role of trastuzumab in second-line treatment for HER2-positive gastric cancer has not yet been addressed. Here, we evaluated the safety and efficacy of adding trastuzumab to ramucirumab and paclitaxel combination as a second-line treatment in HER2-positive gastric cancer progressed after trastuzumab-containing chemotherapy.

Being tested
Trastuzumab + Ramucirumab + 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.

  • Trastuzumab + Ramucirumab + PaclitaxelDrug

    For both Phase Ib and II: Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg on Days 1, 8, 15 and 22, and ramucirumab 8 mg/kg on Days 1 and 15, as well as paclitaxel will be administered intravenously in a 4-week cycle (every 28 days) For Phase Ib, Paclitaxel 80 or 70 mg/m2 (according to dose level) will be administered on Days 1, 8, 15 For Phase II, paclitaxel at RP2D (80 or 70 mg/m2) will be administered on Days 1, 8, 15 of each cycle

Study groups in NCT04888663
Study groupRoleWhat they receive
Study treatmentExperimental(Phase Ib part) Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg IV, ramucirumab 8 mg/kg IV, and paclitaxel 80 or 70 mg/m2 IV (according to dose level) (Phase II part) Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg IV, ramucirumab 8 mg/kg IV, and paclitaxel at RP2D (80 or 70 mg/m2 IV)
Receives: Drug: Trastuzumab + Ramucirumab + Paclitaxel

What is being measured

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

  1. Phase 1b: Maximum tolerated dose of trastuzumab, ramucirumab, and paclitaxel combination treatment in patients with HER2-positive gastric cancer

    Measured: Phase 1b: During the first 4 weeks of treatment

  2. Phase 2: Progression-free survival in patients with HER2-positive gastric cancer receiving trastuzumab, ramucirumab, and paclitaxel combination treatment

    Measured: Phase 2: At 24 weeks after start of treatment

Secondary outcomes (4)

  1. Overall survival

    Measured: through study completion, an average of 2 years

  2. Objective response rate according to RECIST 1.1

    Measured: through study completion, an average of 2 years

  3. Disease control rate according to RECIST 1.1

    Measured: through study completion, an average of 2 years

  4. Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE v4.02

    Measured: Throughout the overall study period as well as up to 3 months after the last dose study treatment for each subject

Timeline

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

  1. First posted17 May 2021
  2. Study start13 Feb 2018
  3. Primary completion2 Sep 2021 (estimated)
  4. Study completion2 Sep 2021 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04888663
Sponsor's protocol ID
4-2017-0275
Status last verified
May 2021
First submitted
9 May 2021
Last updated
21 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim CG, Jung M, Kim HS, Lee CK, Jeung HC, Koo DH, Bae WK, Zang DY, Kim BJ, Kim H, Yun UJ, Che J, Park S, Kim TS, Kwon WS, Park J, Cho SW, Nam CM, Chung HC, Rha SY. Trastuzumab Combined With Ramucirumab and Paclitaxel in Patients With Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Advanced Gastric or Gastroesophageal Junction Cancer. J Clin Oncol. 2023 Sep 20;41(27):4394-4405. doi: 10.1200/JCO.22.02122. Epub 2023 Jun 26.

    PubMed 37364218

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Trastuzumab + Ramucirumab + Paclitaxel in people with Recurrent/Metastatic Gastric 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 11 inclusion and 17 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 21 May 2021. 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 combined 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.

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?

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?

Phase 1b: Maximum tolerated dose of trastuzumab, ramucirumab, and paclitaxel combination treatment in patients with HER2-positive gastric cancer (time frame: Phase 1b: During the first 4 weeks of treatment). 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 NCT04888663, 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 21 May 2021.

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