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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 1/Phase 2
19 Years
N/A
Open (Enrolling)
Both
HER-2 Positive Advanced Gastric Cancer

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Trial Information

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


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)


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety evaluation(phase I)

Outcome Description:

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

Outcome Time Frame:

DLT will be evaluated on Day 21 during cycle 1

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

HM-PHI-A201

NCT ID:

NCT01746771

Start Date:

November 2012

Completion Date:

February 2015

Related Keywords:

  • HER-2 Positive Advanced Gastric Cancer
  • HM781-36B, Paclitaxel, Trastuzumab
  • Stomach Neoplasms

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