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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Hanmi Pharmaceutical Company Limited
Sponsor:
Collaborator:
National OncoVenture
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01746771
First received: December 3, 2012
Last updated: June 20, 2013
Last verified: June 2013
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 48
Study Start Date: November 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HM781-36B(Poziotinib), Paclitaxel, Trastuzumab Drug: HM781-36B(Poziotinib)
Other Names:
  • NOV120101
  • Poziotinib
Drug: Paclitaxel Drug: Trastuzumab

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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 hitory 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746771

Contacts
Contact: Kyung-Mi Park kmpark@hanmi.co.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yung-Jue Bang       bangyj@snu.ac.kr   
Principal Investigator: Yung-Jue Bang         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
National OncoVenture
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01746771     History of Changes
Other Study ID Numbers: HM-PHI-A201
Study First Received: December 3, 2012
Last Updated: June 20, 2013
Health Authority: Korea: Food and Drug Administration

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
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014