Advanced Solid TumorsPhase 1NCT00782574
Phase I AZD2281/Cisplatin in Advanced Solid Tumour Patients
A Phase 1 study testing AZD2281 and Cisplatin in people with Advanced Solid Tumors, run by AstraZeneca at 3 sites in 2 countries.
Trial summary
A Phase I study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AZD2281 and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 12 Nov 2008to 7 Dec 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Life expectancy of at least 12 weeks
- Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
- Patients with measurable or non measurable disease according to RECIST
Who cannot join
- Less than 28 days from active therapy (ie any treatment used to treat the disease) or high dose radiotherapy
- Brain Metastases or spinal cord compression unless irradiated at least 4 weeks before entry and stable without steroid treatment for >1 week
- Persistent CTCAE Grade 2 or greater toxicities (excluding alopecia) caused by prior therapy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
About this study
Official title: A Phase I Open Label, Multi Centre Study of AZD2281 Administered Orally in Combination With Cisplatin, to Assess the Safety and Tolerability in Patients With Advanced Solid Tumours
A Phase I study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled
- Conditions
- Advanced Solid Tumors
- Being tested
- AZD2281, Cisplatin
- Keywords
- Advanced solid tumours, Poly(ADP ribose) polymerases, homologous deficiency, BRCA1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2281Drug
Also called Olaparib; Lynparza
Tablets Oral BID
CisplatinDrug
IV every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator.
Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid).
The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions. Receives: Drug: AZD2281; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of AZD2281 in combination with Cisplatin (eg Adverse Events, Pharmacokinetic for AZD2281, overall response rate) to patients with advanced solid tumours.
Measured: Weekly visits for routine monitoring visits
Secondary outcomes (2)
To compare exposure to AZD2281 when given alone and in combination with Cisplatin (Only in patients receiving continuous dosing of AZD2281).
Measured: PK samples taken at visit 2 and 3
To make a preliminary assessment of the anti-tumour activity of AZD2281 when given in combination with Cisplatin, by measuring overall objective response rate.
Measured: Assessed at screening, visit 9, and at end of every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start12 Nov 2008
- Primary completion1 Feb 2012
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jane Robertson, BSc, MBCHB, MD, Study director, AstraZenecaJudy E Garber, Principal investigator, Dana-Farber Cancer InstituteJ Ballmana Gelpi, Principal investigator, Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782574
- Sponsor's protocol ID
- D0810C00021
- Other IDs
- 2008-000062-24, 2008
- Status last verified
- Dec 2023
- First submitted
- 29 Oct 2008
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open Label, Multi Centre Study of AZD2281 Administered Orally in Combination With Cisplatin, to Assess the Safety and Tolerability in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT00782574
- Acronym / sponsor ID
- D0810C00021
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced solid tumours, Poly(ADP ribose) polymerases, homologous deficiency, BRCA1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2008 (actual)
- Primary completion
- 1 Feb 2012 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 31 Oct 2008 (estimated)
- 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.
A Phase I study to assess the safety and tolerability of AZD2281 in combination with Cisplatin in patients with advanced Solid Tumours. This is an open label-dose finding; to establish the maximum tolerated dose of AZD2281 combined with Cisplatin in patients with advanced solid tumours. Approximately 50 (max 60) patients from 2 countries will be enrolled
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2281, Drug: CisplatinOlaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Life expectancy of at least 12 weeks
- Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
- Patients with measurable or non measurable disease according to RECIST
Key exclusion criteria (3 listed)
- Less than 28 days from active therapy (ie any treatment used to treat the disease) or high dose radiotherapy
- Brain Metastases or spinal cord compression unless irradiated at least 4 weeks before entry and stable without steroid treatment for >1 week
- Persistent CTCAE Grade 2 or greater toxicities (excluding alopecia) caused by prior therapy
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 |
|---|---|---|
| AZD2281Also: Olaparib; LynparzaTablets Oral BID | Drug | 1 |
| CisplatinIV every 3 weeks | Drug | 1 |
Primary outcome
To determine the safety and tolerability of AZD2281 in combination with Cisplatin (eg Adverse Events, Pharmacokinetic for AZD2281, overall response rate) to patients with advanced solid tumours.
Time frame: Weekly visits for routine monitoring visits
2 secondary outcomes
To compare exposure to AZD2281 when given alone and in combination with Cisplatin (Only in patients receiving continuous dosing of AZD2281).
Time frame: PK samples taken at visit 2 and 3
To make a preliminary assessment of the anti-tumour activity of AZD2281 when given in combination with Cisplatin, by measuring overall objective response rate.
Time frame: Assessed at screening, visit 9, and at end of every 2 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 21 Dec 2023.
- D0810C00021 redacted protocolLink provided by the sponsor.
- CSR\_Synopsis\_D0810C00021.pdfLink provided by the sponsor.
- 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
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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.
Jane Robertson, BSc, MBCHB, MD study director
AstraZeneca
Judy E Garber principal investigator
Dana-Farber Cancer Institute
J Ballmana Gelpi principal investigator
Vall d'Hebron
3 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 AZD2281 and Cisplatin in people with Advanced Solid Tumors, run by AstraZeneca at 3 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 3 inclusion and 3 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 21 Dec 2023. 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 United States, Spain. 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?
To determine the safety and tolerability of AZD2281 in combination with Cisplatin (eg Adverse Events, Pharmacokinetic for AZD2281, overall response rate) to patients with advanced solid tumours. (time frame: Weekly visits for routine monitoring visits). 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 21 Dec 2023.