CompletedPhase 1

A Clinical Study to Determine the Pharmacokinetics of Oraxol in Breast Cancer Patients

Taiwan28 participantsStarted 2017-05-09

Plain-language summary

This is a multicenter, open-label, single-arm PK study in patients for whom paclitaxel treatment is indicated.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed written informed consent
✓. Women ≥18 years of age on day of consent
✓. Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
✓. Measurable disease as per RECIST v1.1 criteria
✓. Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) maintain:
✓. Adequate liver function
✓. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

✕. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
✕. If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
✕. Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
✕. Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
✕. Known CNS metastasis, including leptomeningeal involvement
✕. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
✕. Are currently receiving other medications intended for the treatment of their malignancy
✕. Women who are pregnant or breastfeeding

What they're measuring

PK Parameters for paclitaxel_AUC (0-52)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Cmax

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Ctrough(24)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Ctrough(48)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Cmax(0-24)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Cmax(24-48)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Cmax(48-52)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

Trial details

NCT IDNCT03165955

SponsorHealth Hope Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-22

Results submitted2020-05-14

View on ClinicalTrials.gov More Breastcancer trials

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed written informed consent
✓. Women ≥18 years of age on day of consent
✓. Breast cancer in patients for whom treatment with IV paclitaxel at 80 mg/m2 as monotherapy has been recommended by their oncologist
✓. Measurable disease as per RECIST v1.1 criteria
✓. Adequate hematological status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) maintain:
✓. Adequate liver function
✓. Adequate renal function as demonstrated by serum creatinine ≤1.5 x ULN
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

✕. Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs)
✕. If previously treated with a taxane (paclitaxel or docetaxel) as part of anthracycline-based adjuvant chemotherapy or for metastatic disease, the subject relapsed less than 1 year following treatment
✕. Subjects unable to swallow study medication in its intact form or have clinically significant malabsorption syndrome
✕. Only site of metastatic disease is unmeasurable according to RECIST v1.1 criteria
✕. Known CNS metastasis, including leptomeningeal involvement
✕. Received IPs within 14 days or 5 half-lives of the first study dosing day, whichever is longer
✕. Are currently receiving other medications intended for the treatment of their malignancy
✕. Women who are pregnant or breastfeeding

What they're measuring

PK Parameters for paclitaxel_AUC (0-52)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Cmax

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Ctrough(24)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Ctrough(48)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Cmax(0-24)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Cmax(24-48)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4

PK Parameters for paclitaxel_Cmax(48-52)

Timeframe: PK sampling timepoints: predose, and at 1, 2, 3, and 4 hours after dosing of Day 1, 2, 3 at Week 1 and 4