Malignant Solid TumorPhase 1IVIVCNCT03553108
A Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours.
A Phase 1 study testing Olaparib Treatment A, Olaparib Treatment B and Olaparib Treatment C in people with Malignant Solid Tumor, run by AstraZeneca at 3 sites in Belgium.
Trial summary
This is a phase 1 open label, 4 treatment, 4 sequence and 4 period crossover study in subjects with solid tumours no longer responding to, or eligible for standard therapies, and for whom there are no additional standard therapies likely to benefit the subject. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- Olaparib Treatment A, Olaparib Treatment B and Olaparib Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesBelgium
- Study dates
- 16 May 2018to 1 Jul 2020
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Female or male subject, aged > 18 years.
- Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy for which no suitable effective standard therapy is available and in the opinion of the investigator might benefit from olaparib therapy.
- Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- Haemoglobin ≥ 100 g/L with no blood transfusion in the past 28 days.
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
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- Platelet count ≥ 100 x 109/L.
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN.
- Subjects must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test:
- Estimated creatinine clearance =[(140-age [years]) x weight (kg) x 1.2] (x F)a serum creatinine (μmol/L) a where F=0.85 for females and F=1 for males
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Subjects must have a life expectancy ≥ 16 weeks.
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.
- 8 Male subjects must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male subjects should also use a highly effective form of contraception if they are of childbearing potential.
- 9 Subjects must have normal GI tract anatomy and function (see exclusion criteria for specifics).
- 10 Subjects is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Previous randomisation in the present study.
- Participation in another clinical study with an investigational product during the last 1 month.
- Any previous treatment with a PARP inhibitor, including olaparib.
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 ms, electrolyte disturbances, etc.) or subjects with congenital long QT syndrome.
- Subjects receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.
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- Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
- Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) > grade 2) caused by previous cancer therapy, excluding alopecia.
- Subjects with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
- Subjects with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The subject can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Subjects with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
- Major surgery within 2 weeks of starting study treatment and subjects must have recovered from any effects of any major surgery.
- Subjects considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
- Subjects unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication including surgery on the upper GI tract and small bowel, malabsorptive disorders, inflammatory bowel disease, GI motility disorders, chronic diarrhea (more than 3 loose bowel movements per day) chronic constipation (no bowel movement for more than two days), recent (in last week) vomiting.
- Pregnant or breastfeeding women.
- Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus (HIV).
- Subjects with a known hypersensitivity to olaparib or any of the excipients of the product.
- Subjects with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Wilrijk, 2610
About this study
Official title: A Phase 1, Randomised, Open-label, 4-Period Crossover Study to Develop an In Vitro-In Vivo Correlation for Olaparib Tablets in Subjects With Solid Tumors
This is a phase 1 open label, 4 treatment, 4 sequence and 4 period crossover study in subjects with solid tumours no longer responding to, or eligible for standard therapies, and for whom there are no additional standard therapies likely to benefit the subject.
Read the detailed description
The study is an open-label, randomised, 4-period, 4-sequence crossover pharmacokinetic study designed to generate in vivo PK data from tablet variants with different size/geometry and dose, to correlate with their corresponding in vitro dissolution profiles. The duration of each dosing period is 7 days including the washout period. Subjects will be randomised to a treatment sequence, following a balanced Latin Squares design. Twelve subjects who meet inclusion/exclusion criteria and have provided informed consent will be randomly assigned to the treatment sequences: ABCD, BDAC, CADB, or DCBA.
On Day 1 of each period, subjects will receive a single dose of either Treatment A, B, C, or D, according to the randomisation schedule. Serial blood samples for determination of olaparib in plasma will be collected for up to 72 hours.
Cancer subjects with advanced solid tumours are required for this study, as pre-clinical toxicology data preclude the use of olaparib in healthy volunteers. The olaparib doses chosen will deliver exposure at or below that which has been previously demonstrated to be acceptable and tolerated in cancer subjects.
- Conditions
- Malignant Solid Tumor
- Being tested
- Olaparib Treatment A, Olaparib Treatment B, Olaparib Treatment C, Olaparib Treatment D
- Keywords
- Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaparib Treatment ADrug
Olaparib Tablet 25 mg
Olaparib Treatment BDrug
Olaparib Tablet 100 mg
Olaparib Treatment CDrug
Olaparib Tablet 150 mg
Olaparib Treatment DDrug
Olaparib Tablet 250 mg
| Study group | Role | What they receive |
|---|---|---|
| Olaparib Treatment Sequence ABCD | Experimental | On Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours.
A - Olaparib Tablet 25 mg B - Olaparib Tablet 100 mg C - Olaparib Tablet 150 mg D - Olaparib Tablet 250 mg Receives: Drug: Olaparib Treatment A; Drug: Olaparib Treatment B; Drug: Olaparib Treatment C; Drug: Olaparib Treatment D |
| Olaparib Treatment Sequence BDAC | Experimental | On Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours.
B - Olaparib Tablet 100 mg D - Olaparib Tablet 250 mg A - Olaparib Tablet 25 mg C - Olaparib Tablet 150 mg Receives: Drug: Olaparib Treatment A; Drug: Olaparib Treatment B; Drug: Olaparib Treatment C; Drug: Olaparib Treatment D |
| Olaparib Treatment Sequence CADB | Experimental | On Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours.
C - Olaparib Tablet 150 mg A - Olaparib Tablet 25 mg D - Olaparib Tablet 250 mg B - Olaparib Tablet 100 mg Receives: Drug: Olaparib Treatment A; Drug: Olaparib Treatment B; Drug: Olaparib Treatment C; Drug: Olaparib Treatment D |
| Olaparib Treatment Sequence DCBA | Experimental | On Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours.
D - Olaparib Tablet 250 mg C - Olaparib Tablet 150 mg B - Olaparib Tablet 100 mg A - Olaparib Tablet 25 mg Receives: Drug: Olaparib Treatment A; Drug: Olaparib Treatment B; Drug: Olaparib Treatment C; Drug: Olaparib Treatment D |
What is being measured
The primary outcome is the main question the study is designed to answer.
%PECmax
Percent prediction error for Cmax
Measured: 0 to 72 hours
%PEAUC
Percent prediction error for AUC
Measured: 0 to 72 hours
Secondary outcomes (8)
Maximum plasma concentration (Cmax) obtained directly from the observed concentration versus time data.
Evaluation of the PK parameters for the different Olaparib tablet variants.
Measured: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Time to maximum plasma concentration (tmax) obtained directly from the observed concentration versus time data.
Evaluation of the PK parameters for the different Olaparib tablet variants.
Measured: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Area under the plasma concentration-time curve from zero to the time of the last measurable concentration (AUC(0-t)) calculated by linear up/log down trapezoidal summation.
Evaluation of the PK parameters for the different Olaparib tablet variants.
Measured: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Area under the plasma concentration time curve from zero (pre-dose) extrapolated to infinity (AUC)
Evaluation of the PK parameters for the different Olaparib tablet variants. calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the terminal rate constant: AUC(0-t) + Clast/λz.
Measured: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Apparent plasma clearance (CL/F).
Evaluation of the PK parameters for the different Olaparib tablet variants.
Measured: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Terminal half-life (t½). Visual assessment will be used to identify the terminal linear phase of the concentration-time profile.
Evaluation of the PK parameters for the different Olaparib tablet variants.
Measured: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Apparent volume of distribution (Vz/F).
Evaluation of the PK parameters for the different Olaparib tablet variants.
Measured: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Terminal rate constant (λz) estimated by log-linear least squares regression of the terminal part of the concentration-time curve.
Evaluation of the PK parameters for the different Olaparib tablet variants.
Measured: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start16 May 2018
- Primary completion12 Mar 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Model description
- Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Kevin Punie, Principal investigator, Universitaire Aiekenhuizen LeuvenLuc Dirix, Principal investigator, GZA ZiekenhuizenGuy Jerusalem, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553108
- Sponsor's protocol ID
- D0816C00024
- Acronym
- IVIVC
- Status last verified
- Sep 2020
- First submitted
- 14 May 2018
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study team has decided that IPD would not be shared at this moment.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Open-label, 4-Period Crossover Study to Develop an In Vitro-In Vivo Correlation for Olaparib Tablets in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT03553108
- Acronym / sponsor ID
- IVIVC / D0816C00024
- Conditions
- Malignant Solid Tumor
- Keywords
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd, Merck Sharp & Dohme LLC
- Study start
- 16 May 2018 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 12 Jun 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.
This is a phase 1 open label, 4 treatment, 4 sequence and 4 period crossover study in subjects with solid tumours no longer responding to, or eligible for standard therapies, and for whom there are no additional standard therapies likely to benefit the subject.
Detailed description
The study is an open-label, randomised, 4-period, 4-sequence crossover pharmacokinetic study designed to generate in vivo PK data from tablet variants with different size/geometry and dose, to correlate with their corresponding in vitro dissolution profiles. The duration of each dosing period is 7 days including the washout period. Subjects will be randomised to a treatment sequence, following a balanced Latin Squares design. Twelve subjects who meet inclusion/exclusion criteria and have provided informed consent will be randomly assigned to the treatment sequences: ABCD, BDAC, CADB, or DCBA.
On Day 1 of each period, subjects will receive a single dose of either Treatment A, B, C, or D, according to the randomisation schedule. Serial blood samples for determination of olaparib in plasma will be collected for up to 72 hours.
Cancer subjects with advanced solid tumours are required for this study, as pre-clinical toxicology data preclude the use of olaparib in healthy volunteers. The olaparib doses chosen will deliver exposure at or below that which has been previously demonstrated to be acceptable and tolerated in cancer subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition
| Arm | Type | Receives |
|---|---|---|
| Olaparib Treatment Sequence ABCD | Experimental | Drug: Olaparib Treatment A, Drug: Olaparib Treatment B, Drug: Olaparib Treatment C, Drug: Olaparib Treatment DOn Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours. A - Olaparib Tablet 25 mg B - Olaparib Tablet 100 mg C - Olaparib Tablet 150 mg D - Olaparib Tablet 250 mg |
| Olaparib Treatment Sequence BDAC | Experimental | Drug: Olaparib Treatment A, Drug: Olaparib Treatment B, Drug: Olaparib Treatment C, Drug: Olaparib Treatment DOn Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours. B - Olaparib Tablet 100 mg D - Olaparib Tablet 250 mg A - Olaparib Tablet 25 mg C - Olaparib Tablet 150 mg |
| Olaparib Treatment Sequence CADB | Experimental | Drug: Olaparib Treatment A, Drug: Olaparib Treatment B, Drug: Olaparib Treatment C, Drug: Olaparib Treatment DOn Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours. C - Olaparib Tablet 150 mg A - Olaparib Tablet 25 mg D - Olaparib Tablet 250 mg B - Olaparib Tablet 100 mg |
| Olaparib Treatment Sequence DCBA | Experimental | Drug: Olaparib Treatment A, Drug: Olaparib Treatment B, Drug: Olaparib Treatment C, Drug: Olaparib Treatment DOn Day 1 of each period, patients will receive a single dose of either Tablet A, B, C, or D, according to the randomization schedule. Serial blood samples for determination of olaparib in plasma will be collected for 72 hours. D - Olaparib Tablet 250 mg C - Olaparib Tablet 150 mg B - Olaparib Tablet 100 mg A - Olaparib Tablet 25 mg |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Provision of informed consent prior to any study specific procedures.
- Female or male subject, aged > 18 years.
- Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy for which no suitable effective standard therapy is available and in the opinion of the investigator might benefit from olaparib therapy.
- Subjects must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- Estimated creatinine clearance =[(140-age [years]) x weight (kg) x 1.2] (x F)a serum creatinine (μmol/L) a where F=0.85 for females and F=1 for males
Key exclusion criteria (19 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Previous randomisation in the present study.
- Participation in another clinical study with an investigational product during the last 1 month.
- Any previous treatment with a PARP inhibitor, including olaparib.
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 ms, electrolyte disturbances, etc.) or subjects with congenital long QT syndrome.
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 |
|---|---|---|
| Olaparib Treatment AOlaparib Tablet 25 mg | Drug | Olaparib Treatment Sequence ABCD, Olaparib Treatment Sequence BDAC, Olaparib Treatment Sequence CADB, Olaparib Treatment Sequence DCBA |
| Olaparib Treatment BOlaparib Tablet 100 mg | Drug | Olaparib Treatment Sequence ABCD, Olaparib Treatment Sequence BDAC, Olaparib Treatment Sequence CADB, Olaparib Treatment Sequence DCBA |
| Olaparib Treatment COlaparib Tablet 150 mg | Drug | Olaparib Treatment Sequence ABCD, Olaparib Treatment Sequence BDAC, Olaparib Treatment Sequence CADB, Olaparib Treatment Sequence DCBA |
| Olaparib Treatment DOlaparib Tablet 250 mg | Drug | Olaparib Treatment Sequence ABCD, Olaparib Treatment Sequence BDAC, Olaparib Treatment Sequence CADB, Olaparib Treatment Sequence DCBA |
Primary outcome
%PECmax
Time frame: 0 to 72 hours
Percent prediction error for Cmax
%PEAUC
Time frame: 0 to 72 hours
Percent prediction error for AUC
8 secondary outcomes
Maximum plasma concentration (Cmax) obtained directly from the observed concentration versus time data.
Time frame: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Time to maximum plasma concentration (tmax) obtained directly from the observed concentration versus time data.
Time frame: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Area under the plasma concentration-time curve from zero to the time of the last measurable concentration (AUC(0-t)) calculated by linear up/log down trapezoidal summation.
Time frame: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Area under the plasma concentration time curve from zero (pre-dose) extrapolated to infinity (AUC)
Time frame: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Apparent plasma clearance (CL/F).
Time frame: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Terminal half-life (t½). Visual assessment will be used to identify the terminal linear phase of the concentration-time profile.
Time frame: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Apparent volume of distribution (Vz/F).
Time frame: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Terminal rate constant (λz) estimated by log-linear least squares regression of the terminal part of the concentration-time curve.
Time frame: Blood samples will be taken at the following sampling times: Pre-dose, 30 min, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr (Day 1), 24 hr (Day2), 48 hr (Day 3), and 72 hr (Day 4). After each dosing at each of the 4 treatment cycles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: No. Study team has decided that IPD would not be shared at this moment.
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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.
Kevin Punie principal investigator
Universitaire Aiekenhuizen Leuven
Luc Dirix principal investigator
GZA Ziekenhuizen
Guy Jerusalem principal investigator
Centre Hospitalier Universitaire de Liege
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olaparib Treatment A, Olaparib Treatment B and Olaparib Treatment C in people with Malignant Solid Tumor, run by AstraZeneca at 3 sites in Belgium.
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 17 inclusion and 19 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: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
%PECmax (time frame: 0 to 72 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?
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 1 Oct 2020.