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 range

18 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years

Sex

FEMALE

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

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