AzTrials
AzTrials

Solid TumorsPhase 1NCT00777582

Phase I Comparative Bioavailability Study

A Phase 1 study testing AZD2281 in people with Solid Tumors, run by AstraZeneca at 10 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this phase I randomised cross over study is to determine and compare the bioavailability of two different oral formulations of AZD2281 in advanced solid tumour cancer patients Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Solid Tumors
What is being tested?
AZD2281
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
10 sitesin 4 countries
Study dates
27 Oct 2008to 31 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Histologically confirmed malignant advanced solid tumour, which is refractory to standard therapies (except Group 8 patients who must not be platinum refractory) or for which no suitable effective standard therapy exists
  • Patients must have adequate organ and bone marrow function measured within 7 days prior to administration of study treatment
  • Female patients must have evidence of non-child bearing status: negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing, or postmenopausal status

Who cannot join

  • Patients receiving chemotherapy, radiotherapy (except for palliative reasons) or any other anti-cancer therapy within 4 weeks of the last dose prior to study entry. Patients may continue the use of biphosphonates for bone metastases and corticosteroids
  • Patients with symptomatic uncontrolled brain metastases
  • Major surgery within 2 weeks of starting study and patients must have recovered from any effects of any major surgery
  • Patients who are platinum refractory (Group 8 only)
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia (Group 8 only).

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

United Kingdom7 sites

  • Research Site

    Edinburgh, EH4 2XR

  • Research Site

    London, NW1 2PG

  • Research Site

    Manchester, M20 4BX

  • Research Site

    Newcastle upon Tyne, NE7 7DN

  • Research Site

    Northwood, HA6 2RN

  • Research Site

    Oxford, OX3 7LE

  • Research Site

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia1 site

  • Research Site

    Randwick, 2031

Other trials in Australia

Belgium1 site

  • Research Site

    Leuven, 3000

Other trials in Belgium

Switzerland1 site

  • Research Site

    Bellinzona, CH-6500

Other trials in Switzerland

About this study

Official title: A Phase I, Randomised, 2 Period Cross Over Study to Determine the Comparative Bioavailability of Two Different Oral Formulations of AZD2281 in Cancer Patients With Advanced Solid Tumours

The purpose of this phase I randomised cross over study is to determine and compare the bioavailability of two different oral formulations of AZD2281 in advanced solid tumour cancer patients

Conditions
Solid Tumors
Being tested
AZD2281
Keywords
Poly (ADP ribose) polymerases, Homologous Recombination Deficiency (HRD), Advanced solid tumours

What participants receive

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

  • AZD2281Drug

    Also called Olaparib

    Oral single dose formulation

Study groups in NCT00777582
Study groupRoleWhat they receive
Treatment AExperimental300mg bid (twice daily) tablet dose
Receives: Drug: AZD2281
Treatment BExperimental400 mg twice daily (bid) capsule dose
Receives: Drug: AZD2281
Treatment CExperimental400mg bid (twice daily) tablet dose
Receives: Drug: AZD2281

What is being measured

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

  1. PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation

    Measured: Blood samples (12) will be taken at pre-defined intervals following dosing of a single capsule and a single tablet dose

  2. Continued Supply Phase: To enable patients to continue to receive treatment with AZD2281. Safety and tolerability data will be collected to further determine the safety and tolerability of the capsule formulation of AZD2281 in these patients

    Measured: every 28 days

  3. Continued Supply Expansion Phase: To compare the safety and tolerability of the tablet and capsule formulation of AZD2281 in all patients: Safety, AEs, Physical Exam, vital signs

    Measured: at every visit

  4. Dose Escalation Phase of continued supply expansion: To determine safety & tolerability of higher than 200mg bid (to 400mg) of tablet & compare safety & tolerability profile of tablet with 400mg capsule

    Measured: at every visit

  5. Randomised tablet formulation continued supply expansion phase (Group 8): To determine the safety and tolerability profile of selected tablet dose schedules of the melt-extrusion (tablet) formulation.

    Measured: at every visit

Secondary outcomes (11)

  1. PK Phase Secondary Outcome: To generate single dose PK data for the new tablet formulation in man, and to generate information on dose linearity for the new tablet formulation

    Measured: Blood samples (12) will be taken at pre-defined intervals prior to and following dosing of a single capsule and a single tablet dose

  2. To compare the extent of PARP inhibition achieved in peripheral blood mononuclear cells (PBMCs) following dosing of both the new tablet formulation and existing capsule formulation

    Measured: Blood samples (4) will be taken at pre-defined intervals prior to and following dosing of a single capsule and a single tablet dose

  3. To determine the safety and tolerability of AZD2281 for both the new tablet formulation and existing capsule formulations

    Measured: every 28 days

  4. Continued Supply Expansion Phase: To compare the steady state exposure achieved with 200mg bid tablet formulation and 400mg bid capsule formulation

    Measured: at visit 3 and visit 4

  5. Continued Supply Expansion Phase: To describe the efficacy data observed in patients treated with the capsule and the tablet

    Measured: RECIST, Progression Free Survival, Best overall response and CA-125 response

  6. Dose Escalation Phase of the continued supply expansion: To determine the single dose and steady state exposures achieved with higher doses of AZD2281 tablet formulation

    Measured: at every visit

  7. Dose Escalation Phase of the continued supply expansion: To compare between patients the single dose and steady state exposures of AZD2281 achieved with selected tablet doses and the 400mg bid capsule dose

    Measured: at every visit

  8. Dose Escalation Phase of the continued supply expansion: To describe the efficacy data observed in patients treated with the capsule formulation and the tablet formulation

    Measured: at every visit

  9. Randomised tablet formulation continued supply expansion phase (Group 8): To determine the single dose and steady state exposures achieved with the selected table dose schedules of AZD2281 melt-extrusion (tablet) formulation

    Measured: at every visit

  10. Randomised tablet formulation continued supply expansion phase (Group 8): To obtain a preliminary assessment of the effect of food on the exposure to AZD2281 following dosing of the melt-extrusion (tablet) formulation.

    Measured: at every visit

  11. Randomised tablet formulation continued supply expansion phase (Group 8): To describe the efficacy data observed in patients treated with the melt-extrusion (tablet) formulation

    Measured: at every visit

Timeline

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

  1. First posted22 Oct 2008 (estimated)
  2. Study start27 Oct 2008
  3. Primary completion6 Feb 2009
  4. Study completion31 Mar 2027 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00777582
Sponsor's protocol ID
D0810C00024
Other IDs
2008-003697-18, 2008
Status last verified
Aug 2026
First submitted
21 Oct 2008
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
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

Publications

  • Mateo J, Moreno V, Gupta A, Kaye SB, Dean E, Middleton MR, Friedlander M, Gourley C, Plummer R, Rustin G, Sessa C, Leunen K, Ledermann J, Swaisland H, Fielding A, Bannister W, Nicum S, Molife LR. An Adaptive Study to Determine the Optimal Dose of the Tablet Formulation of the PARP Inhibitor Olaparib. Target Oncol. 2016 Jun;11(3):401-15. doi: 10.1007/s11523-016-0435-8.

    PubMed 27169564

  • Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8.

    PubMed 26961146

  • Ang JE, Gourley C, Powell CB, High H, Shapira-Frommer R, Castonguay V, De Greve J, Atkinson T, Yap TA, Sandhu S, Banerjee S, Chen LM, Friedlander ML, Kaufman B, Oza AM, Matulonis U, Barber LJ, Kozarewa I, Fenwick K, Assiotis I, Campbell J, Chen L, de Bono JS, Gore ME, Lord CJ, Ashworth A, Kaye SB. Efficacy of chemotherapy in BRCA1/2 mutation carrier ovarian cancer in the setting of PARP inhibitor resistance: a multi-institutional study. Clin Cancer Res. 2013 Oct 1;19(19):5485-93. doi: 10.1158/1078-0432.CCR-13-1262. Epub 2013 Aug 6.

    PubMed 23922302

  • Sandhu SK, Omlin A, Hylands L, Miranda S, Barber LJ, Riisnaes R, Reid AH, Attard G, Chen L, Kozarewa I, Gevensleben H, Campbell J, Fenwick K, Assiotis I, Olmos D, Yap TA, Fong P, Tunariu N, Koh D, Molife LR, Kaye S, Lord CJ, Ashworth A, de Bono J. Poly (ADP-ribose) polymerase (PARP) inhibitors for the treatment of advanced germline BRCA2 mutant prostate cancer. Ann Oncol. 2013 May;24(5):1416-8. doi: 10.1093/annonc/mdt074. Epub 2013 Mar 22. No abstract available.

    PubMed 23524863

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD2281 in people with Solid Tumors, run by AstraZeneca at 10 sites in 4 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United Kingdom, Australia, Belgium, Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

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?

PK Phase Primary Outcome: To determine the comparative bioavailability of a new tablet formulation of AZD2281 compared to the existing capsule formulation (time frame: Blood samples (12) will be taken at pre-defined intervals following dosing of a single capsule and a single tablet dose). The study lists 5 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 NCT00777582, which also lists 4 linked publications.

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 6 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in