A Study DHP107, a Novel Oral Paclitaxel Formulation, in Patients With Advanced Solid Tumours or Gastric Cancer
Primary Purpose
Solid Tumor, Stage IV Gastric Cancer
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor
Eligibility Criteria
Inclusion Criteria:
- Patients between 18 and 70 years old
- 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
- Adequate bone marrow function, liver function and adequate kidney function
- Eastern Cooperative Oncology Group performance status ≤ 2
- Life expectancy of 3 month or more
- Written informed consent
Exclusion Criteria:
- Major infectious or neurological disease and bowel obstruction
- Brain metastasis or hematologic malignancy
- Patients who underwent surgery, radiation therapy, hormone or chemotherapy within 4 weeks prior to the beginning of investigational drug administration
- 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)
- 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
- 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)
- Patients with prior history of participating in a clinical trial within 30 days from registration for current clinical trial
- Patient with history of alcohol or drug abuse in the recent 3 months
- Pregnant women, nursing mothers, or patients of childbearing age who did not agree to contraception (both men and women)
- Patients with (or suspected to have) abnormality in bile acid secretion (e.g.,. patients with resected gallbladder)
- 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)
- Patients with history of severe hypersensitive reaction to active ingredient and excipient of the investigational drug
- Patient who are in a state that is deemed inappropriate to participate in the clinical trial by the investigator
Sites / Locations
- Asan Medical Center, University of Ulsan College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DHP107(Oral paclitaxel)
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of participants with dose limiting toxicity(DLT) to determine maximum tolerated dose(MTD)
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
Secondary Outcome Measures
To identify the dose limiting toxicity(DLT) and the safety (toxicity) of DHP107
Adverse events are evaluated in the first cycle(4-week) according to NCI CTCAE v4.0
To evaluate efficacy(tumor response) by RECIST criteria version 1.1
PK parameters for DHP107 derived from determining their plasma concentrations using validated assays.
Full Information
NCT ID
NCT02890511
First Posted
August 29, 2016
Last Updated
February 9, 2017
Sponsor
Daehwa Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02890511
Brief Title
A Study DHP107, a Novel Oral Paclitaxel Formulation, in Patients With Advanced Solid Tumours or Gastric Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daehwa Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Stage IV Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DHP107(Oral paclitaxel)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
DHP107
Intervention Description
Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed consent.
Primary Outcome Measure Information:
Title
Number of participants with dose limiting toxicity(DLT) to determine maximum tolerated dose(MTD)
Description
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
Time Frame
First cycle of treatment (4-week)
Secondary Outcome Measure Information:
Title
To identify the dose limiting toxicity(DLT) and the safety (toxicity) of DHP107
Description
Adverse events are evaluated in the first cycle(4-week) according to NCI CTCAE v4.0
Time Frame
First cycle of treatment (4-week)
Title
To evaluate efficacy(tumor response) by RECIST criteria version 1.1
Time Frame
every 8 weeks (±1 week)
Title
PK parameters for DHP107 derived from determining their plasma concentrations using validated assays.
Time Frame
First cycle of treatment (4-week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 18 and 70 years old
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
Adequate bone marrow function, liver function and adequate kidney function
Eastern Cooperative Oncology Group performance status ≤ 2
Life expectancy of 3 month or more
Written informed consent
Exclusion Criteria:
Major infectious or neurological disease and bowel obstruction
Brain metastasis or hematologic malignancy
Patients who underwent surgery, radiation therapy, hormone or chemotherapy within 4 weeks prior to the beginning of investigational drug administration
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)
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
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)
Patients with prior history of participating in a clinical trial within 30 days from registration for current clinical trial
Patient with history of alcohol or drug abuse in the recent 3 months
Pregnant women, nursing mothers, or patients of childbearing age who did not agree to contraception (both men and women)
Patients with (or suspected to have) abnormality in bile acid secretion (e.g.,. patients with resected gallbladder)
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)
Patients with history of severe hypersensitive reaction to active ingredient and excipient of the investigational drug
Patient who are in a state that is deemed inappropriate to participate in the clinical trial by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang, M.D., Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28196905
Citation
Ryu MH, Ryoo BY, Kim TW, Kim SB, Lim HS, Bae KS, Park SR, Jo YW, Cho HJ, Kang YK. A Phase I/IIa Study of DHP107, a Novel Oral Paclitaxel Formulation, in Patients with Advanced Solid Tumors or Gastric Cancer. Oncologist. 2017 Feb;22(2):129-e8. doi: 10.1634/theoncologist.2016-0273. Epub 2017 Feb 14.
Results Reference
derived
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A Study DHP107, a Novel Oral Paclitaxel Formulation, in Patients With Advanced Solid Tumours or Gastric Cancer
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