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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890511
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Daehwa Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Solid Tumor Stage IV Gastric Cancer Drug: Paclitaxel Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel

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 Name: DHP107




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. To evaluate efficacy(tumor response) by RECIST criteria version 1.1 [ Time Frame: every 8 weeks (±1 week) ]
  3. PK parameters for DHP107 derived from determining their plasma concentrations using validated assays. [ Time Frame: First cycle of treatment (4-week) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890511


Locations
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Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Daehwa Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Yoon-Koo Kang, M.D., Ph.D Asan Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daehwa Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02890511    
Other Study ID Numbers: 107CS-2
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action