Colon CancerPhase 1CapecitabineNCT03435666

A Bioequivalence Study of Capecitabine Tablets 500 mg in Adult Cancer Patients Under Fed Condition

A Phase 1 study testing Capecitabine and XELODA in people with Colon Cancer and Breast Cancer, run by Qilu Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Purpose: To demonstrate the bioequivalence between Capecitabine Tablets 500 mg of Qilu Pharmaceutical Co., Ltd, China in comparison with XELODA® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA, Inc. Design: two treatment, three period, three sequence, reference replicate crossover, single dose. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Colon Cancer, Breast Cancer
What is being tested?: Capecitabine and XELODA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: No sites listed yet
Study dates: May 2018to Nov 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or non-pregnant, non-lactating female patient of age between 18 to 60 years (both inclusive).
Patients with have histopathologically /cytologically confirmed Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
Or Patients with histopathologically /cytologically confirmed colorectal carcinoma with evidence of metastasis when treatment with fluoropyrimidine therapy alone is preferred Or Patients with histopathologically /cytologically confirmed breast cancer with evidence of metastasis
Resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents). Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
Cancer patients already receiving a stable twice-daily dosing regimen of capecitabine (who have completed at least one cycle of chemotherapy) as prescribed by the reference product label (i.e. 1250 mg/m2, twice daily, equivalent to 2500 mg/m2 total daily dose, for two-weeks followed by a one-week rest period given as three-week cycles)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Show all 18Show fewer

Adequate cardiac function [left ventricular ejection fraction (LVEF) ≥ 50 %]
Patient with adequate bone marrow(ANC ≥ 1500/mm3, Platelet count ≥ 100,000/mm3 , Hemoglobin ≥ 9.0 g/ dL); renal (Serum Creatinine ≤ 1.5 times ULN and creatinine clearance ≥ 51 to 80 mL/min [Cockroft and Gault]) and hepatic function (Bilirubin ≤ 1.5 times ULN, ALT/AST ≤ 3 times ULN (≤ 5 x ULN if liver metastases present)) .
Patient willing and able to give written informed consent for participation in the study and comply with the study protocol.
No persistent clinically significant toxicities from prior medications at screening.
Subject with clinically acceptable chest X-Ray (P/A view) whose X-Ray was taken not more than 3 months prior to screening.
Females of child-bearing potential (FOCP) must agree to use an acceptable method of birth control such as sexual abstinence or at least 2 reliable modes of contraception, one of which must be a double-barrier method (e.g., condom with spermicidal gel or diaphragm with spermicidal gel) or IUD or vaginal spermicidal suppository from screening until 6 months after last dose of study drug. [Note: Use of hormonal contraception (pills/hormonal intrauterine device etc,) is not allowed].
OR Post-menopausal females defined as at least 12 consecutive months with no menses without an alternative medical cause OR Surgically sterilized females with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy. Females without documented evidence of surgery and those who have undergone tubal ligation will be considered of child bearing potential.
Male patient must agree to use an acceptable method of birth control such as sexual abstinence or barrier method of contraception (i.e. condom) from screening until 3 months after last dose of study drug. Subject agrees to accept the risk that pregnancy in female partner could still result despite using birth control devices.
Cancer patients should preferably be on monotherapy. However, cancer patients receiving concomitant drug(s) are allowed to participate, provided:
The concomitant medication is the same for all the study period and clearly documented.
Patients do not require any change their concurrent medications during the study period
The concurrent medications do not interfere with the assay for measuring the drug in plasma.

Who cannot join

Known hypersensitivity or contraindication to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or
Patients with known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
Prior unanticipated severe reaction to Capecitabine or metabolites and to fluoropyrimidine therapy
Patients with a prior history of coronary artery disease,
Patients receiving phenytoin, warferin, other coumarin-derivative anticoagulants, leucoverin, CYP2C9 at the time of screening or anticipated use of these drugs during the study period. [If the subject was on any of these drugs before screening, a wash out period of at least 5 half-lives must have elapsed since the last dose of such drug.]
Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (> 6 months of screening) CNS metastases and are now stable and asymptomatic are allowed.

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Presence of active infections
Any of the following cardiac conditions:
Unstable angina
Myocardial infarction within the past 6 months
NYHA (New York State Heart Association) class II-IV heart failure
Severe uncontrolled ventricular arrhythmias
Clinically significant pericardial disease
Electrocardiographic evidence of acute ischemic or active conduction system abnormalities
Any other cardiac illness that could lead to a safety risk to the patient in case of enrolment in the study
Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
Patients who have had experienced a severe mucocutaneous reaction during prior capecitabine treatment.
Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI CTCAE criteria.
Known, existing uncontrolled coagulopathy.
Subject with positive human immunodeficiency virus (HIV) infection, a positive hepatitis screen including hepatitis B surface antigen, HCV and HAV antibodies.
Subject with clinically significant active infection and symptoms of noninfectious pneumonitis as judged by investigator.
Use of any recreational drugs or history of drug addiction.
Have a history of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to Screening
Positive test results for urine drug scan (except for prescribed benzodiazepines) or breath alcohol test at baseline
Subject with a history of difficulty in donating blood or difficulty in accessibility of veins.
An unusual or abnormal diet, for two weeks prior to receiving any medication and throughout subject's participation in the study, for whatever reason e.g. because of fasting due to religious reasons.
Receipt of any Investigational Medicinal Product within the past 30 days of randomization or has less than 5 half life from previous IMP receipt.
History of donation of blood/loss of blood (without replenishment) (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study.
History of administration of live vaccines within the past 4 weeks of screening or scheduled to receive a live vaccine during the study period until end study assessments.
Subject with any factor/condition preventing oral consumption of tablet.
Subject with post-major surgery (major surgery is defined as a procedure requiring general anesthesia), open biopsy, or significant traumatic injury or with unhealed wound or not recovered from prior major surgery within 4 weeks from screening.
Any severe, acute, or chronic medical, psychiatric or social condition; or laboratory abnormality that may increase the risk of trial participation or investigational agent administration, may interfere with the informed consent process and/or with compliance with the requirements of the trial, or may interfere with the interpretation of the trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.

About this study

Official title: A Multicenter, Open Label, Randomized, Balanced, Two Treatment, Three Period, Three Sequence, Reference Replicate Crossover, Single Dose, Bioequivalence Fed Study of Capecitabine Tablets in Comparison With XELODA in Adult Cancer Patients

Design: two treatment, three period, three sequence, reference replicate crossover, single dose.

Test Drug: Capecitabine Tablets; Reference drug: XELODA Sample size: Around 45 patients will be enrolled to have at least 39 evaluable patients in the study.

Read the detailed description

Objectives:

Primary Objective: To demonstrate the bioequivalence between Capecitabine Tablets 500 mg of Qilu Pharmaceutical Co., Ltd, China in comparison with XELODA® (Capecitabine) Tablets 500 mg, Distributed by Genentech USA, Inc. following a single oral dose administration in adult cancer patients under fed condition.

Secondary Objective: To monitor the safety and tolerability profile of the subjects exposed to the Investigational Medicinal Product.

Study Design: a randomized, multicenter, open label, balanced, two treatment, three period, three sequence, reference replicate crossover, single dose, bioequivalence study under fed conditions.

Number of subjects: at least 39 evaluable patients Mode of Administration for Test and Reference product: Patient will be randomized to one of the three treatment sequences i.e. TRR, RTR or RRT. Where T-Test drug and R-Reference drug. The study medication will be administered in the morning of Day 1 (Period I of the study), Day 2(Period II of the study) and Day 3 (Period III of the study).

Since, the patients are on a twice daily dosing regimen the patients should receive their usual dose of capecitabine as per their dosing regimen between each subsequent study periods. The drug product used to administer the dose between the study periods can be the same or any approved product as that used by the patients for their current dosing regimen. The morning and evening doses will be based on BSA.

Blood collection times: pre-dose blood sample of 03 mL (00.00) will be collected within 5 minutes before dosing in each period of the study. After dosing in each period (Day 1, Day 2 and Day 3), the post-dose blood samples of 03mL each will be drawn at 0.17 (10min), 0.33 (20min), 0.50 (30 min),0.67 (40min), 0.83 (50min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours following drug administration.

Bioequivalence Criteria:

For Capecitabine, the bioequivalence will be concluded based on within-subject standard deviation of reference formulation, termed as SWR.

Reference - Scale Average Bioequivalence Approach:

When SWR ≥ 0.294 for any of the primary pharmacokinetic parameters, below mentioned both the criteria must be satisfied: The 95% upper confidence bound for (μT- μR)2/S2WR determined must be ≤ θ, or equivalently, a 95% upper confidence bound for (μT- μR)2-θ*S2WR must be ≤ 0; and the point estimate (test/reference geometric mean ratio) must fall within [0.80, 1.25].

Conventional Average Bioequivalence Approach:

When SWR < 0.294 for any of the primary pharmacokinetic parameters, 90% confidence interval for the geometric least square means ratio (T/R) of that parameter must be fall within the acceptance range of 80.00% to 125.00%.

Conditions: Colon Cancer, Breast Cancer
Being tested: Capecitabine, XELODA
Medical subject headings: Colonic Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CapecitabineDrug
Single oral dose (1250mg/m2) Capecitabine or XELODA in each period.
XELODADrug
Single oral dose (1250mg/m2) Capecitabine or XELODA in each period.

Study groups in NCT03435666
Study group	Role	What they receive
Capecitabine	Experimental	Capecitabine is the test product.In period 1, period 2 and period 3, 13 of 39 Subjects were given Single oral dose (1250 mg/m2) Capecitabine. Receives: Drug: Capecitabine; Drug: XELODA
XELODA	Active comparator	XELODA is the reference product.In period 1, period 2 and period 3, 13 of 39 Subjects were given Single oral dose (1250 mg/m2) XELODA. Receives: Drug: Capecitabine; Drug: XELODA

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Maximum plasma Capecitabine concentration.
Measured: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
AUC0-t
The area under the plasma concentration time curve from zero to the last measurable concentration.
Measured: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours

Secondary outcomes (5)

AUC0-∞
The area under the plasma concentration time curve from zero to infinity.
Measured: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
Tmax
Time of the maximum measured plasma concentration.
Measured: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
Kel
The elimination rate constant associated with the terminal (log-linear) portion of the curve. Estimated by linear regression of time vs. log concentration.
Measured: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
t½
The terminal elimination half-life calculated by 0.693/Kel.
Measured: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
AUC_%Extrap_obs
Percentage of AUC0-∞ to extrapolation from Tlast to infinity
Measured: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2018Nov 2018

First posted19 Feb 2018
Study startMay 2018 (estimated)
Primary completionOct 2018 (estimated)
Study completionNov 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colon CancerStudies of the same condition, open and under way.
More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 45 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03435666
Sponsor's protocol ID: 17-VIN-0855
Acronym: Capecitabine
Status last verified: Feb 2018
First submitted: 10 Feb 2018
Last updated: 19 Feb 2018
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open Label, Randomized, Balanced, Two Treatment, Three Period, Three Sequence, Reference Replicate Crossover, Single Dose, Bioequivalence Fed Study of Capecitabine Tablets in Comparison With XELODA in Adult Cancer Patients
ClinicalTrials.gov ID: NCT03435666
Acronym / sponsor ID: Capecitabine / 17-VIN-0855
Conditions: Colon Cancer, Breast Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 45 participants (estimated)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2018 (estimated)
Primary completion: Oct 2018 (estimated)
Study completion: Nov 2018 (estimated)
First posted: 19 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Design: two treatment, three period, three sequence, reference replicate crossover, single dose.

Test Drug: Capecitabine Tablets; Reference drug: XELODA Sample size: Around 45 patients will be enrolled to have at least 39 evaluable patients in the study.

Detailed description

Objectives:

Secondary Objective: To monitor the safety and tolerability profile of the subjects exposed to the Investigational Medicinal Product.

Study Design: a randomized, multicenter, open label, balanced, two treatment, three period, three sequence, reference replicate crossover, single dose, bioequivalence study under fed conditions.

Bioequivalence Criteria:

For Capecitabine, the bioequivalence will be concluded based on within-subject standard deviation of reference formulation, termed as SWR.

Reference - Scale Average Bioequivalence Approach:

Conventional Average Bioequivalence Approach:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Capecitabine	Experimental	Drug: Capecitabine, Drug: XELODACapecitabine is the test product.In period 1, period 2 and period 3, 13 of 39 Subjects were given Single oral dose (1250 mg/m2) Capecitabine.
XELODA	Active comparator	Drug: Capecitabine, Drug: XELODAXELODA is the reference product.In period 1, period 2 and period 3, 13 of 39 Subjects were given Single oral dose (1250 mg/m2) XELODA.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (18 listed)

Male or non-pregnant, non-lactating female patient of age between 18 to 60 years (both inclusive).
Patients with have histopathologically /cytologically confirmed Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
Or Patients with histopathologically /cytologically confirmed colorectal carcinoma with evidence of metastasis when treatment with fluoropyrimidine therapy alone is preferred Or Patients with histopathologically /cytologically confirmed breast cancer with evidence of metastasis
Resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents). Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
Cancer patients already receiving a stable twice-daily dosing regimen of capecitabine (who have completed at least one cycle of chemotherapy) as prescribed by the reference product label (i.e. 1250 mg/m2, twice daily, equivalent to 2500 mg/m2 total daily dose, for two-weeks followed by a one-week rest period given as three-week cycles)

Key exclusion criteria (32 listed)

Known hypersensitivity or contraindication to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or
Patients with known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
Prior unanticipated severe reaction to Capecitabine or metabolites and to fluoropyrimidine therapy
Patients with a prior history of coronary artery disease,
Patients receiving phenytoin, warferin, other coumarin-derivative anticoagulants, leucoverin, CYP2C9 at the time of screening or anticipated use of these drugs during the study period. [If the subject was on any of these drugs before screening, a wash out period of at least 5 half-lives must have elapsed since the last dose of such drug.]

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CapecitabineSingle oral dose (1250mg/m2) Capecitabine or XELODA in each period.	Drug	Capecitabine, XELODA
XELODASingle oral dose (1250mg/m2) Capecitabine or XELODA in each period.	Drug	Capecitabine, XELODA

Primary outcome

Cmax
Time frame: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
Maximum plasma Capecitabine concentration.
AUC0-t
Time frame: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
The area under the plasma concentration time curve from zero to the last measurable concentration.

5 secondary outcomes

AUC0-∞
Time frame: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
Tmax
Time frame: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
Kel
Time frame: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
t½
Time frame: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours
AUC_%Extrap_obs
Time frame: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capecitabine and XELODA in people with Colon Cancer and Breast Cancer, run by Qilu Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Pre-dose, 0.17 (10 min), 0.33 (20 min), 0.50 (30 min), 0.67 (40 min), 0.83 (50 min), 1.00, 1.25 (1h15min), 1.50 (1h30min), 1.75 (1h45min), 2, 2.25 (2h15min), 2.5 (2h30min), 2.75 (2h45min), 3.00, 3.50 (3h30min), 4.00, 5.00, 6.00, 7.00, and 8.00 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03435666.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.