Advanced Solid MalignanciesPhase 1NCT05573724
Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies
A Phase 1 study testing AZD5305 and Itraconazole in people with Advanced Solid Malignancies, run by AstraZeneca at 2 sites in 2 countries.
Trial summary
This study is a single-arm, open-label, multi-centre drug-drug interaction (DDI) study of AZD5305 administered orally in patients with advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- AZD5305 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Nov 2022to 17 May 2024
- 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 signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
- Males and females aged ≥ 18 years at the time of screening.
- Patients with documented evidence of locally advanced unresectable or metastatic solid tumours, excluding lymphoma, who have exhausted standard of care options (or for which no standard therapies exist) and may be suitable for AZD5305 monotherapy treatment.
- Adequate organ and marrow function.
- An Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0 to 2 with no deterioration over the previous 2 weeks.
- Life expectancy ≥ 12 weeks.
- Female patients of childbearing potential. Must have a negative pregnancy test result at screening and prior to each Part of study intervention.
- Female patients must not breastfeed and must not donate or retrieve ova for their own use from screening to approximately 6 months after the last dose of study intervention.
Who cannot join
- Previous enrolment in the present study (ie, dosing with AZD5305 previously initiated in this study).
- Positive for detection of drugs of abuse or alcohol at screening.
- Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 enzyme (CYP3A4) substrates, strong, and moderate inhibitors or inducers.
- Patients with germline Breast cancer gene-mutated relapsed advanced ovarian cancer who have received three or more previous lines of chemotherapy.
- Using of proton pump inhibitors, histamine H2 receptor antagonists and other antiacid agents.
- Using of calcium channel blockers.
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- Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsade's de Pointes (TdP).
- During the 4 weeks prior to the first dose, receiving continuous corticosteroids.
- Major surgery within 4 weeks of the first dose of study intervention.
- Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study intervention.
- Treatment with any of the following: any investigational agents or study interventions from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study intervention; any other anticancer treatment within the following time periods prior to the first dose of study intervention: Cytotoxic and non-cytotoxic treatment: 3 weeks or five half-lives (whichever is shorter); Biological products including immuno-oncology agents: 4 weeks before enrolment.; any live virus or bacterial vaccine within 28 days of the first dose of study intervention.
- Any concurrent anticancer therapy or concurrent use of prohibited medications.
- With the exception of alopecia, and peripheral neuropathy; any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
- Any known history of persisting (> 2 weeks) severe pancytopenia.
- Spinal cord compression, or brain metastases unless asymptomatic and treated and stable and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent.
- Any evidence of severe or uncontrolled systemic diseases, including, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus.
- Patients with any known predisposition to bleeding.
- Any of the following cardiac criteria: mean resting QTcF > 450 ms or QTcF < 340 ms obtained from triplicate ECGs and averaged, recorded within 5 minutes; any factors that increase the risk of QT prolongation, shortening or risk of arrhythmic events such as hypokalaemia, congenital long or short QT syndrome, family history of long QT syndrome, familial short QT syndrome, or unexplained sudden death under 40 years of age; any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, second- or third-degree atrioventricular block, and clinically significant sinus node dysfunction not treated with pacemaker.
- Other cardiovascular diseases.
- Patients with history of MDS/AML or with features suggestive of MDS/AML.
- Refractory nausea and vomiting, chronic GI diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305.
- Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study intervention or interpretation of patient safety or study results.
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- Uncontrolled intercurrent illness within the last 12 months.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Non-randomized, Open-label, Fixed-sequence Phase I Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD5305 in Patients With Advanced Solid Malignancies
This study is a single-arm, open-label, multi-centre drug-drug interaction (DDI) study of AZD5305 administered orally in patients with advanced solid tumours.
Read the detailed description
This study will comprise of two study parts, Part A and Part B. Part A of the study will assess the effect of multiple doses of Itraconazole on the single dose pharmacokinetic (PK) parameters of AZD5305 which will last up to 13 days. The patients will then continue into Part B and receive AZD5305 monotherapy at the discretion of the Investigator if the patients are deemed to still derive benefit from continued treatment until disease progression.
The Part A of this study follows a non-randomized, open-label, 2-intervention design. Patients will receive the following two study interventions, AZD5305 and Itraconazole: a single oral dose of AZD5305 alone, multiple oral doses of itraconazole alone, and then a single oral dose of AZD5305 administered concomitantly with multiple doses of itraconazole.
In Part B, the patients may continue the study with AZD5305 monotherapy after completing Part A of the study. AZD5305 monotherapy will continue until disease progression, unacceptable toxicities, initiation of alternative anticancer therapy, withdrawal of consent, or other reasons to discontinue study treatment occur.
- Conditions
- Advanced Solid Malignancies
- Being tested
- AZD5305, Itraconazole
- Keywords
- Tumors, Pharmacokinetics, Itraconazole, AZD5305, Safety, Tolerability
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5305Drug
In Part A, the participants will receive a single dose of AZD5305 on Day 1 and Day 7.
In Part B, the participants will receive AZD5305 once daily.
ItraconazoleDrug
In Part A, the participants will receive Itraconazole twice daily on Day 4 and once daily on Days 5-12
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Part A:
The participants will receive a single oral dose of AZD5305 on Day 1, followed by a 2-day washout. Then Itraconazole will be dosed for 3 days [BD] on Day 4 and [OD] on Days 5 and 6, then a single oral dose of AZD5305 administered concurrently with Itraconazole on Day 7 and only Itraconazole on Days 8 to 12.
Part B:
Patients proceeding to Part B after completing Part A of the study will receive AZD5305 OD as monotherapy. Receives: Drug: AZD5305; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Area under the concentration-time curve from time zero to infinity (AUCinf)
The effect of Itraconazole on the AUCinf of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite[s], if applicable) relative to reference intervention (AZD5305 alone) of AUCinf will be presented.
Measured: Day 1-4, Day 7-13
Part A: AUC from time zero to time of last measurable concentration (AUClast)
The effect of Itraconazole on the AUClast of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite[s], if applicable) relative to reference intervention (AZD5305 alone) of AUClast will be presented.
Measured: Day 1-4, Day 7-13
Part A: Maximum plasma drug concentration (Cmax)
The effect of Itraconazole on the Cmax of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite[s], if applicable) relative to reference intervention (AZD5305 alone) of Cmax will be presented.
Measured: Day 1-4, Day 7-13
Part A: Apparent total body clearance of drug from plasma (CL/F)
The effect of Itraconazole on the PK of AZD5305 will be assessed.
Measured: Day 1-4, Day 7-13
Part A: Terminal elimination half-life (t½λz)
The effect of Itraconazole on the PK of AZD5305 will be assessed.
Measured: Day 1-4, Day 7-13
Part A: Time to maximum observed concentration (Tmax)
The effect of Itraconazole on the PK of AZD5305 will be assessed.
Measured: Day 1-4, Day 7-13
Part A: Apparent volume of distribution based on the terminal phase (Vz/F)
The effect of Itraconazole on the PK of AZD5305 will be assessed.
Measured: Day 1-4, Day 7-13
Secondary outcomes (5)
Part A and Part B: Number of participants with Adverse Events (AEs) and Serious Adverse events (SAEs)
Participants with potentially clinically significant AEs and SAEs will be determined.
Measured: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 day 1 until Post treatment follow up (28 days after last dose) (approximately 12 months)
Part A and Part B: Number of Participants with Laboratory Value Abnormalities and/or AEs
Participants with potentially clinically significant laboratory values will be determined.
Measured: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 Day 1 until Post treatment follow-up (28 days after last dose) (approximately 12 months)
Part A and Part B: Number of Participants with Vital Sign Abnormalities and/or AEs
Participants with potentially clinically significant vital signs values will be determined.
Measured: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 Day 1 until Post treatment follow-up (28 days after last dose) (approximately 12 months)
Part A and Part B: Number of Participants with Electrocardiogram (ECG) Abnormalities and/or AEs
Participants with potentially clinically significant ECG values will be determined.
Measured: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 Day 1 until Post treatment follow-up (28 days after last dose) (approximately 12 months)
Part A and Part B: Number of Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) Abnormalities and/or AEs
Participants with potentially clinically significant ECOG PS values will be determined.
Measured: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 Day 1 until Post treatment follow-up (28 days after last dose) (approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start7 Nov 2022
- Primary completion17 Apr 2023
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573724
- Sponsor's protocol ID
- D9720C00005
- Other IDs
- 2022-001450-33
- Status last verified
- Jun 2024
- First submitted
- 7 Oct 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open-label, Fixed-sequence Phase I Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD5305 in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT05573724
- Acronym / sponsor ID
- D9720C00005
- Conditions
- Advanced Solid Malignancies
- Keywords
- Tumors, Pharmacokinetics, Itraconazole, AZD5305, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 10 Oct 2022 (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 study is a single-arm, open-label, multi-centre drug-drug interaction (DDI) study of AZD5305 administered orally in patients with advanced solid tumours.
Detailed description
This study will comprise of two study parts, Part A and Part B. Part A of the study will assess the effect of multiple doses of Itraconazole on the single dose pharmacokinetic (PK) parameters of AZD5305 which will last up to 13 days. The patients will then continue into Part B and receive AZD5305 monotherapy at the discretion of the Investigator if the patients are deemed to still derive benefit from continued treatment until disease progression.
The Part A of this study follows a non-randomized, open-label, 2-intervention design. Patients will receive the following two study interventions, AZD5305 and Itraconazole: a single oral dose of AZD5305 alone, multiple oral doses of itraconazole alone, and then a single oral dose of AZD5305 administered concomitantly with multiple doses of itraconazole.
In Part B, the patients may continue the study with AZD5305 monotherapy after completing Part A of the study. AZD5305 monotherapy will continue until disease progression, unacceptable toxicities, initiation of alternative anticancer therapy, withdrawal of consent, or other reasons to discontinue study treatment occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: AZD5305, Drug: ItraconazolePart A: The participants will receive a single oral dose of AZD5305 on Day 1, followed by a 2-day washout. Then Itraconazole will be dosed for 3 days [BD] on Day 4 and [OD] on Days 5 and 6, then a single oral dose of AZD5305 administered concurrently with Itraconazole on Day 7 and only Itraconazole on Days 8 to 12. Part B: Patients proceeding to Part B after completing Part A of the study will receive AZD5305 OD as monotherapy. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
- Males and females aged ≥ 18 years at the time of screening.
- Patients with documented evidence of locally advanced unresectable or metastatic solid tumours, excluding lymphoma, who have exhausted standard of care options (or for which no standard therapies exist) and may be suitable for AZD5305 monotherapy treatment.
- Adequate organ and marrow function.
- An Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0 to 2 with no deterioration over the previous 2 weeks.
Key exclusion criteria (25 listed)
- Previous enrolment in the present study (ie, dosing with AZD5305 previously initiated in this study).
- Positive for detection of drugs of abuse or alcohol at screening.
- Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 enzyme (CYP3A4) substrates, strong, and moderate inhibitors or inducers.
- Patients with germline Breast cancer gene-mutated relapsed advanced ovarian cancer who have received three or more previous lines of chemotherapy.
- Using of proton pump inhibitors, histamine H2 receptor antagonists and other antiacid agents.
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 |
|---|---|---|
| AZD5305In Part A, the participants will receive a single dose of AZD5305 on Day 1 and Day 7. In Part B, the participants will receive AZD5305 once daily. | Drug | Treatment Arm |
| ItraconazoleIn Part A, the participants will receive Itraconazole twice daily on Day 4 and once daily on Days 5-12 | Drug | Treatment Arm |
Primary outcome
Part A: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Day 1-4, Day 7-13
The effect of Itraconazole on the AUCinf of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite[s], if applicable) relative to reference intervention (AZD5305 alone) of AUCinf will be presented.
Part A: AUC from time zero to time of last measurable concentration (AUClast)
Time frame: Day 1-4, Day 7-13
The effect of Itraconazole on the AUClast of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite[s], if applicable) relative to reference intervention (AZD5305 alone) of AUClast will be presented.
Part A: Maximum plasma drug concentration (Cmax)
Time frame: Day 1-4, Day 7-13
The effect of Itraconazole on the Cmax of AZD5305 will be assessed. The ratios of geometric means of test intervention (AZD5305 + Itraconazole; parent and metabolite[s], if applicable) relative to reference intervention (AZD5305 alone) of Cmax will be presented.
Part A: Apparent total body clearance of drug from plasma (CL/F)
Time frame: Day 1-4, Day 7-13
The effect of Itraconazole on the PK of AZD5305 will be assessed.
Part A: Terminal elimination half-life (t½λz)
Time frame: Day 1-4, Day 7-13
The effect of Itraconazole on the PK of AZD5305 will be assessed.
Part A: Time to maximum observed concentration (Tmax)
Time frame: Day 1-4, Day 7-13
The effect of Itraconazole on the PK of AZD5305 will be assessed.
Part A: Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Day 1-4, Day 7-13
The effect of Itraconazole on the PK of AZD5305 will be assessed.
5 secondary outcomes
Part A and Part B: Number of participants with Adverse Events (AEs) and Serious Adverse events (SAEs)
Time frame: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 day 1 until Post treatment follow up (28 days after last dose) (approximately 12 months)
Part A and Part B: Number of Participants with Laboratory Value Abnormalities and/or AEs
Time frame: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 Day 1 until Post treatment follow-up (28 days after last dose) (approximately 12 months)
Part A and Part B: Number of Participants with Vital Sign Abnormalities and/or AEs
Time frame: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 Day 1 until Post treatment follow-up (28 days after last dose) (approximately 12 months)
Part A and Part B: Number of Participants with Electrocardiogram (ECG) Abnormalities and/or AEs
Time frame: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 Day 1 until Post treatment follow-up (28 days after last dose) (approximately 12 months)
Part A and Part B: Number of Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) Abnormalities and/or AEs
Time frame: Part A: From screening until post-treatment follow-up (28 days after last dose) (approximately 13 days if continuing into Part B); Part B: From Cycle 1 Day 1 until Post treatment follow-up (28 days after last dose) (approximately 12 months)
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 18 Jun 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5305 and Itraconazole in people with Advanced Solid Malignancies, run by AstraZeneca at 2 sites in 2 countries.
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 8 inclusion and 25 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 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Moldova, Romania. 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?
Part A: Area under the concentration-time curve from time zero to infinity (AUCinf) (time frame: Day 1-4, Day 7-13). The study lists 7 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 18 Jun 2024.