A Study DHP107, a Novel Oral Paclitaxel Formulation, in Patients With Advanced Solid Tumours or Gastric Cancer

February 9, 2017 updated by: Daehwa Pharmaceutical Co., Ltd.

A Study of DHP107, a Novel Oral Paclitaxel Formulation, to Determine Maximum Tolerated Dose and Recommended Dose for Phase II Trial in Patients With Advanced Solid Cancer

A study of DHP107, a novel oral paclitaxel formulation, to determine maximum tolerated dose and recommended dose for phase II trial in patients with advanced solid cancer and explore efficacy of DHP107 in patients with gastric cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Primary objective To determine the maximum tolerated dose and the recommended dose for phase 2 clinical trial for the repeated administration of DHP107 (oral paclitaxel) on advanced solid cancer patients

  2. Secondary objectives

    • To identify the dose limiting toxicity and the safety (toxicity) of DHP107
    • To evaluate the efficacy (tumor response rate) of DHP107
    • To assess pharmacokinetic (PK) characteristics of DHP107

Study Type

Interventional

Enrollment (Actual)

28

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, University of Ulsan College of Medicine

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients between 18 and 70 years old
  2. Patients prognosed with advanced or metastatic solid cancer by histopathology or cytology analysis who have no available standard therapy or who have failed at least once with the standard therapy
  3. Adequate bone marrow function, liver function and adequate kidney function
  4. Eastern Cooperative Oncology Group performance status ≤ 2
  5. Life expectancy of 3 month or more
  6. Written informed consent

Exclusion Criteria:

  1. Major infectious or neurological disease and bowel obstruction
  2. Brain metastasis or hematologic malignancy
  3. Patients who underwent surgery, radiation therapy, hormone or chemotherapy within 4 weeks prior to the beginning of investigational drug administration
  4. Patients with the history of failure to the taxane line of chemotherapy (with the exception of when it was used before 6 month as adjuvant therapy or when the treatment was discontinued due to docetaxel related side effect)
  5. Patients who are required to continuously take P-gp (P-glycoprotein) suppressor, immune suppressor, proton-pump inhibitor or H2-receptor antagonist during clinical trial period
  6. Patients deemed by the investigator to suffer from severe heart disease (myocardial infarction, congestive heart failure, arrythmia accompanying drastic changes on ECG, severe or unstable angina pectoris, or other severe heart disease) or accompanying other severe internal diseases (such as uncontrollable diabetes, chronic obstructive pulmonary disease)
  7. Patients with prior history of participating in a clinical trial within 30 days from registration for current clinical trial
  8. Patient with history of alcohol or drug abuse in the recent 3 months
  9. Pregnant women, nursing mothers, or patients of childbearing age who did not agree to contraception (both men and women)
  10. Patients with (or suspected to have) abnormality in bile acid secretion (e.g.,. patients with resected gallbladder)
  11. Patients who had a history of serious gastrointestinal bleeding, or with diseases that could affect the absorption of oral medication (malabsorption syndrome, active peptic ulcer)
  12. Patients with history of severe hypersensitive reaction to active ingredient and excipient of the investigational drug
  13. Patient who are in a state that is deemed inappropriate to participate in the clinical trial by the investigator

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: DHP107(Oral paclitaxel)
  • Phase I (determining MTD) The patients diagnosed with either advanced or metastatic solid cancers were enrolled. The administered dose was escalated in a step-wise manner by an increment of 2 x 50 mg/m2 at each dose level. Three patients were treated for toxicity evaluation for each dose level.
  • Phase IIa (efficacy evaluation) The safety and efficacy of the corresponding dose was investigated more closely by increasing the patient number to 6 or more patients in the dose tentatively determined as recommended dose for phase IIa clinical trial.
Drug: Paclitaxel
Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed consent.
Other Names:
  • DHP107

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with dose limiting toxicity(DLT) to determine maximum tolerated dose(MTD)
Time Frame: First cycle of treatment (4-week)
To determine the dose at which no more than one patient out of up to 6 patients at the same dose level experience a drug-related dose-limiting toxicity
First cycle of treatment (4-week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify the dose limiting toxicity(DLT) and the safety (toxicity) of DHP107
Time Frame: First cycle of treatment (4-week)
Adverse events are evaluated in the first cycle(4-week) according to NCI CTCAE v4.0
First cycle of treatment (4-week)
To evaluate efficacy(tumor response) by RECIST criteria version 1.1
Time Frame: every 8 weeks (±1 week)
every 8 weeks (±1 week)
PK parameters for DHP107 derived from determining their plasma concentrations using validated assays.
Time Frame: First cycle of treatment (4-week)
First cycle of treatment (4-week)

Collaborators and Investigators

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

Sponsor

Daehwa Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Yoon-Koo Kang, M.D., Ph.D, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107CS-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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