Clinical Trials List
Protocol NumberKX-ORADOX-002
2019-03-01 - 2021-02-28
Phase I
Recruiting3
ICD-9185
Malignant neoplasm of prostate
An Openlabel, Pilot Pharmacokinetic Study to Determine the Bioavailability, Safety, and Tolerability of a Single Dose of Oradoxel in Metastatic Prostate Cancer Patients Treated With Intravenou s Docetaxel
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2023/03/10
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yao-Yu Hsieh Division of Hematology & Oncology
- Wei-Hong Cheng Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
- Huey-En Tzeng Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Prostate Cancer
Objectives
To determine the absolute bioavailability and pharmacokinetics of orally administered docetaxel as Oradoxel (oral HM30181 methanesulfonate monohydrate and oral docetaxel) in participants being treated with intravenous (IV) docetaxel and determine the safety and tolerability of Oradoxel.
Test Drug
Oradoxel (Docetaxel + HM30181)
Active Ingredient
Dosage Form
capsule
tablet
tablet
Dosage
30mg(Docetaxel)
15mg(HM30181)
15mg(HM30181)
Endpoints
• To determine the absolute bioavailability and pharmacokinetics of orally administered
docetaxel as Oradoxel (oral HM30181 methanesulfonate monohydrate and oral docetaxel)
in participants being treated with intravenous (IV) docetaxel
• To determine the safety and tolerability of Oradoxel
docetaxel as Oradoxel (oral HM30181 methanesulfonate monohydrate and oral docetaxel)
in participants being treated with intravenous (IV) docetaxel
• To determine the safety and tolerability of Oradoxel
Inclution Criteria
1. Signed written informed consent
2. Males ≥18 years of age
3. Metastatic prostate cancer patients who are scheduled to receive their prescribed dose of treatment with IV docetaxel. Patients may be receiving steroid treatment or ADT for prostate cancer, but other concomitant cancer chemotherapy is not permitted.
4. Adequate hematologic status as demonstrated by not requiring transfusion support or
granulocyte-colony stimulating factor (G-CSF) to maintain:
• Absolute neutrophil count (ANC) ≥1500 cells/mm^3
• Platelet count ≥100 x 10^9/L
• Hemoglobin (Hgb) ≥90 g/L
5. Adequate liver function as demonstrated by:
• Total bilirubin of < upper limit of normal (ULN)
• Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN
• Alkaline phosphatase (ALP) ≤2.5x ULN or <5x ULN if bone metastases are present
6. Adequate renal function as demonstrated by serum creatinine ≤177 μmol/L or creatinine clearance >60 mL/min as calculated by the Cockcroft and Gault formula
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
8. Life expectancy of at least 6 months.
9. Willing to fast for 8 hours before and 4 hours after Oradoxel administration.
10. Willing to abstain from alcohol consumption for 3 days prior to Study Period 1 through the Final Visit.
11. Willing to refrain from caffeine consumption for 12 hours prior to each dose of study drug through the completion of protocol-specified PK sampling on Day 4 in Study Periods 1 and 2.
12.Sexually active participants must use a double barrier method of contraception during the study and agree to continue the use of contraception for at least 6 months after the last dose of study drug.
2. Males ≥18 years of age
3. Metastatic prostate cancer patients who are scheduled to receive their prescribed dose of treatment with IV docetaxel. Patients may be receiving steroid treatment or ADT for prostate cancer, but other concomitant cancer chemotherapy is not permitted.
4. Adequate hematologic status as demonstrated by not requiring transfusion support or
granulocyte-colony stimulating factor (G-CSF) to maintain:
• Absolute neutrophil count (ANC) ≥1500 cells/mm^3
• Platelet count ≥100 x 10^9/L
• Hemoglobin (Hgb) ≥90 g/L
5. Adequate liver function as demonstrated by:
• Total bilirubin of < upper limit of normal (ULN)
• Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN
• Alkaline phosphatase (ALP) ≤2.5x ULN or <5x ULN if bone metastases are present
6. Adequate renal function as demonstrated by serum creatinine ≤177 μmol/L or creatinine clearance >60 mL/min as calculated by the Cockcroft and Gault formula
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
8. Life expectancy of at least 6 months.
9. Willing to fast for 8 hours before and 4 hours after Oradoxel administration.
10. Willing to abstain from alcohol consumption for 3 days prior to Study Period 1 through the Final Visit.
11. Willing to refrain from caffeine consumption for 12 hours prior to each dose of study drug through the completion of protocol-specified PK sampling on Day 4 in Study Periods 1 and 2.
12.Sexually active participants must use a double barrier method of contraception during the study and agree to continue the use of contraception for at least 6 months after the last dose of study drug.
Exclusion Criteria
1. Currently taking a prohibited concomitant medication, other than a premedication, that is:
• Strong inhibitors (eg, ketoconazole) or inducers (eg, rifampicin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study)
• Known P-gp inhibitors or inducers. Participants who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ≥1 week before dosing and remain off that medication through the end of PK sampling after the administration of the second study treatment
• An oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of dosing in the study
2. Unresolved toxicity from prior chemotherapy (participants must have recovered from all significant toxicity to ≤ Grade 1 CTCAE toxicity from previous anticancer treatments or previous investigational agents). This does not extend to symptoms or findings that are
attributable to the underlying disease
3. Planning to receive other medical, surgical, or radiological treatments for prostate cancer during the course of this study. However, steroids or ADT may be used as clinically indicated.
4. Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer.
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant myocardial infarction within the last 6 months, unstable angina pectoris, clinically significant cardiac arrhythmia, bleeding disorder, chronic pulmonary disease requiring oxygen, or psychiatric illness/social situations that would
limit compliance with study requirements
6. Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption
7. A known history of allergy to docetaxel, Cremophor or polysorbate 80 (Tween 80)
8. Any other condition which the Investigator believes would make participation in the study not acceptable.
• Strong inhibitors (eg, ketoconazole) or inducers (eg, rifampicin or St. John's Wort) of CYP3A4 (within 2 weeks prior to the start of dosing in the study)
• Known P-gp inhibitors or inducers. Participants who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication ≥1 week before dosing and remain off that medication through the end of PK sampling after the administration of the second study treatment
• An oral medication with a narrow therapeutic index known to be a P-gp substrate within 24 hours prior to start of dosing in the study
2. Unresolved toxicity from prior chemotherapy (participants must have recovered from all significant toxicity to ≤ Grade 1 CTCAE toxicity from previous anticancer treatments or previous investigational agents). This does not extend to symptoms or findings that are
attributable to the underlying disease
3. Planning to receive other medical, surgical, or radiological treatments for prostate cancer during the course of this study. However, steroids or ADT may be used as clinically indicated.
4. Received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer.
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant myocardial infarction within the last 6 months, unstable angina pectoris, clinically significant cardiac arrhythmia, bleeding disorder, chronic pulmonary disease requiring oxygen, or psychiatric illness/social situations that would
limit compliance with study requirements
6. Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption
7. A known history of allergy to docetaxel, Cremophor or polysorbate 80 (Tween 80)
8. Any other condition which the Investigator believes would make participation in the study not acceptable.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
20 participants
