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

March 1, 2016 updated by: Hanmi Pharmaceutical Company Limited

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed advanced gastric cancer including gastroesophageal junction adenocarcinoma
  2. At least one measurable lesion defined by RECIST(v1.1)
  3. FISH+ or IHC3+ (regardless of FISH results)
  4. Age≥19
  5. ECOG ≤ 2
  6. Life expectancy ≥ 12 weeks
  7. Adequate bone marrow and no abnormal heart and lung function
  8. No radiotherapy, other anticancer drugs or immunotherapy is allowed during this study
  9. 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

Exclusion Criteria:

  1. Patients with a history of hypersensitivity to Trastuzumab and who have been treated with medicine including Cremophor EL
  2. Patients who have a current active malignancy other than gastric adenocarcinoma (with exception of non-melanoma skin cancer or cervical cancer in situ)
  3. Patients who have previously received taxane-based chemotherapy
  4. The presence of central nervous system metastases
  5. Patients who have a blood tumor such as leukemia, or who had previously received, or are planning to receive, the bone marrow transplant
  6. Patients with uncontrolled infection
  7. Patients who have GI malabsorption or difficulty taking oral medication
  8. Patients with following diseases are excluded:
  9. Patients with psychiatric or congenital disorder which can affect adherence or make hard to follow the requirements of the protocol
  10. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HM781-36B, Paclitaxel, Trastuzumab
HM781-36B(Poziotinib): QD*2weeks/3weeks Paclitaxel: 175mg/m2 Trastuzumab(Herceptin): 8mg/kg
Drug: HM781-36B(Poziotinib)
QD*2weeks/3weeks
Other Names:
  • NOV120101
  • Poziotinib
Drug: Paclitaxel
175mg/m2
Drug: Trastuzumab
8mg/kg
Other Names:
  • Herceptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation(phase I)
Time Frame: DLT will be evaluated on Day 21 during cycle 1
Dose limiting toxicity (DLT), Maximum tolerance dose (MTD)
DLT will be evaluated on Day 21 during cycle 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy evaluation(Phase II)
Time Frame: Efficacy will be evaluated every 6 weeks or 9 weeks
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)
Efficacy will be evaluated every 6 weeks or 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Collaborators

National OncoVenture

Investigators

  • Study Director: YoHan Kim, M.D., Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 9, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-PHI-A201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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