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HER-2 Positive Advanced Gastric CancerPhase 1/2NCT01746771

A Phase I-II Study of HM781-36B Combined With Paclitaxel and Trastuzumab in HER-2 Positive Advanced Gastric Cancer

A Phase 1/2 study testing HM781-36B(Poziotinib), Paclitaxel and Trastuzumab in people with HER-2 Positive Advanced Gastric Cancer, run by Hanmi Pharmaceutical Company Limited 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

[Phase I] The main objective of this study is to evaluate the safety, tolerability and determine the Recommended Dose (RD) of HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab [Phase II] The main objective of this study is to evaluate anticancer activity through determination of response rate of… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
HER-2 Positive Advanced Gastric Cancer
What is being tested?
HM781-36B(Poziotinib), Paclitaxel and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSouth Korea
Study dates
Nov 2012to Aug 2015
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 confirmed advanced gastric cancer including gastroesophageal junction adenocarcinoma
  • At least one measurable lesion defined by RECIST(v1.1)
  • FISH+ or IHC3+ (regardless of FISH results)
  • Age≥19
  • ECOG ≤ 2
  • Life expectancy ≥ 12 weeks
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  • Adequate bone marrow and no abnormal heart and lung function
  • No radiotherapy, other anticancer drugs or immunotherapy is allowed during this study
  • Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Who cannot join

  • Patients with a history of hypersensitivity to Trastuzumab and who have been treated with medicine including Cremophor EL
  • Patients who have a current active malignancy other than gastric adenocarcinoma (with exception of non-melanoma skin cancer or cervical cancer in situ)
  • Patients who have previously received taxane-based chemotherapy
  • The presence of central nervous system metastases
  • Patients who have a blood tumor such as leukemia, or who had previously received, or are planning to receive, the bone marrow transplant
  • Patients with uncontrolled infection
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  • Patients who have GI malabsorption or difficulty taking oral medication
  • Patients with following diseases are excluded:
  • Patients with psychiatric or congenital disorder which can affect adherence or make hard to follow the requirements of the protocol
  • Pregnant or breastfeeding women or women of childbearing who do not use an appropriate method of contraception (male patient should also use an appropriate method of contraception)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Phase I-II Study to Assess the Safety, Efficacy and Pharmacokinetic Profile of HM781-36B Combined With Paclitaxel and Trastuzumab in Patients With HER-2 Positive Advanced Gastric Cancer

[Phase I] The main objective of this study is to evaluate the safety, tolerability and determine the Recommended Dose (RD) of HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab

[Phase II] The main objective of this study is to evaluate anticancer activity through determination of response rate of HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab in patients with HER-2 positive advanced gastric cancer

Read the detailed description

Besides the main objectives, there are other objectives as follows:

[Phase I]

  1. To assess the pharmacokinetic profile of HM781-36B(Poziotinib) combined with Paclitaxel and Trastuzumab
  2. To evaluate anticancer activity of HM781-36B(Poziotinib) combined with Paclitaxel and Trastuzumab in patients with HER-2 positive advanced gastric cancer
  3. To evaluate PFS(Progression-Free Survival), TTP (Time To Tumor Progression), and DOR (Duration of Overall Response)

[Phase II]

  1. To assess the safety, tolerability of HM781-36B(Poziotinib) combined with Paclitaxel and Trastuzumab
  2. To evaluate tumor response through determination of disease control rate , PFS(Progression-Free Survival), TTP (Time To Tumor Progression), and DOR (Duration of Overall Response)
Being tested
HM781-36B(Poziotinib), Paclitaxel, Trastuzumab
Keywords
HM781-36B, Paclitaxel, Trastuzumab

What participants receive

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

  • HM781-36B(Poziotinib)Drug

    Also called NOV120101, Poziotinib

    QD*2weeks/3weeks

  • PaclitaxelDrug

    175mg/m2

  • TrastuzumabDrug

    Also called Herceptin

    8mg/kg

Study groups in NCT01746771
Study groupRoleWhat they receive
HM781-36B, Paclitaxel, TrastuzumabExperimentalHM781-36B(Poziotinib): QD*2weeks/3weeks Paclitaxel: 175mg/m2 Trastuzumab(Herceptin): 8mg/kg
Receives: Drug: HM781-36B(Poziotinib); Drug: Paclitaxel; Drug: Trastuzumab

What is being measured

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

  1. Safety evaluation(phase I)

    Dose limiting toxicity (DLT), Maximum tolerance dose (MTD)

    Measured: DLT will be evaluated on Day 21 during cycle 1

Secondary outcomes (1)

  1. Efficacy evaluation(Phase II)

    Efficacy evaluation; phase II (Simon's two-stage minimax design): Disease Control Rate (CR, PR, SD), PFS(Progression-Free Survival), TTP (Time To Tumor Progression), and DOR (Duration of Overall Response)

    Measured: Efficacy will be evaluated every 6 weeks or 9 weeks

Timeline

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

  1. First posted11 Dec 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionAug 2015
  4. Study completionAug 2015

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
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746771
Sponsor's protocol ID
HM-PHI-A201
Status last verified
Mar 2016
First submitted
3 Dec 2012
Last updated
3 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HM781-36B(Poziotinib), Paclitaxel and Trastuzumab in people with HER-2 Positive Advanced Gastric Cancer, run by Hanmi Pharmaceutical Company Limited 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 9 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 3 Mar 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 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?

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?

Safety evaluation(phase I) (time frame: DLT will be evaluated on Day 21 during cycle 1). 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 NCT01746771.

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 3 Mar 2016.

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