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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Solid Tumor, Stage IV Gastric Cancer

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHP107(Oral paclitaxel)<br>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<br>* Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed consent.<br>* Other names: DHP107;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 |  | every 8 weeks (±1 week) | 
| PK parameters for DHP107 derived from determining their plasma concentrations using validated assays. |  | First cycle of treatment (4-week) |