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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746771
First Posted: December 11, 2012
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National OncoVenture
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  Purpose

[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


Condition Intervention Phase
HER-2 Positive Advanced Gastric Cancer Drug: HM781-36B(Poziotinib) Drug: Paclitaxel Drug: Trastuzumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

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


Secondary Outcome Measures:
  • 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)


Enrollment: 44
Study Start Date: November 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Herceptin

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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746771


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
National OncoVenture
Investigators
Study Director: YoHan Kim, M.D. Hanmi Pharmaceutical Company Limited
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01746771     History of Changes
Other Study ID Numbers: HM-PHI-A201
First Submitted: December 3, 2012
First Posted: December 11, 2012
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by Hanmi Pharmaceutical Company Limited:
HM781-36B, Paclitaxel, Trastuzumab

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action