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

NCT01746771 | Completed Phase 1

• 1 other identifier: HM-PHI-A201
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 HM781-36B(Poziotinib)combined with Paclitaxel and Trastuzumab in patients with HER-2 positive advanced gastric cancer

Conditions

HER-2 Positive Advanced Gastric Cancer

Keywords

HM781-36B, Paclitaxel, Trastuzumab

Outcome Measures

Primary Outcomes (1)

• Safety evaluation(phase I)

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

  DLT will be evaluated on Day 21 during cycle 1

Secondary Outcomes (1)

• Efficacy evaluation(Phase II)

  Efficacy will be evaluated every 6 weeks or 9 weeks

Study Arms (1)

HM781-36B, Paclitaxel, Trastuzumab

EXPERIMENTAL

HM781-36B(Poziotinib): QD\*2weeks/3weeks Paclitaxel: 175mg/m2 Trastuzumab(Herceptin): 8mg/kg

Drug: HM781-36B(Poziotinib); Drug: Paclitaxel; Drug: Trastuzumab

Interventions

HM781-36B(Poziotinib) DRUG

QD\*2weeks/3weeks

Also known as: NOV120101, Poziotinib

HM781-36B, Paclitaxel, Trastuzumab

Paclitaxel DRUG

175mg/m2

HM781-36B, Paclitaxel, Trastuzumab

Trastuzumab DRUG

8mg/kg

Also known as: Herceptin

HM781-36B, Paclitaxel, Trastuzumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead
• National OncoVenture: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

HM781-36B; Paclitaxel; Trastuzumab

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• YoHan Kim, M.D.

  Hanmi Pharmaceutical Company Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 11, 2012
• Study Start: November 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

KR (1)