Ovarian NeoplasmsPhase 2ICEBERG 3NCT00628251

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer

A Phase 2 study testing AZD2281 and Liposomal Doxorubicin in people with Ovarian Neoplasms, run by AstraZeneca at 24 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy. Read more about this study

Who is it for?: Ages 18 to 130 years, women only
Conditions the study is for: Ovarian Neoplasms
What is being tested?: AZD2281 and Liposomal Doxorubicin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 24 sitesin 9 countries
Study dates: 30 Jul 2008to 19 Sep 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Advanced ovarian cancer with positive BRCA1 or BRCA2 status
Progressive or recurrent disease after platinum-based chemotherapy
Measurable disease by RECIST

Who cannot join

Previous anthracycline treatment
Brain metastases
Less than 28 days since last treatment used to treat the disease
Considered a poor medical risk due to a serious uncontrolled disorder

Trial locations and contacts

24 sites in 9 countries.

Country

City, postcode or hospital

24 sites in 9 countries

United States6 sites

Research Site
Boca Raton, Florida, 33428
Research Site
Boston, Massachusetts, 02115
Research Site
Houston, Texas, 77030
Research Site
Los Angeles, California, 90048
Research Site
New York, New York, 10065
Research Site
San Francisco, California, 94115

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United Kingdom5 sites

Research Site
Cambridge, CB2 0QQ
Research Site
Edinburgh, EH4 2XR
Research Site
London, SE1 9RT
Research Site
Manchester, M20 4BX
Research Site
Sutton, SM2 5PT

Other trials in United Kingdom

Australia3 sites

Research Site
East Melbourne, 3002
Research Site
Melbourne, Parkville, VIC 3050
Research Site
Randwick, 2031

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Israel3 sites

Research Site
Haifa, 31096
Research Site
Ramat Gan, 52621
Research Site
Tel Aviv, 6423906

Other trials in Israel

Germany2 sites

Research Site
Cologne, 50937
Research Site
München, 81377

Other trials in Germany

Spain2 sites

Research Site
Barcelona, 08035
Research Site
Hospitalet deLlobregat, 08907

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Belgium1 site

Research Site
Leuven, 3000

Other trials in Belgium

Poland1 site

Research Site
Szczecin, 70-111

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Sweden1 site

Research Site
Lund, 22185

Other trials in Sweden

About this study

Official title: A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy

Conditions: Ovarian Neoplasms
Being tested: AZD2281, Liposomal Doxorubicin
Keywords: Advanced ovarian cancer, BRCA1 protein, BRCA2 protein, Poly(ADP ribose) polymerases
Medical subject headings: Ovarian Neoplasms, Fanconi Anemia, Complementation Group D1

What participants receive

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

AZD2281Drug
Also called Olaparib
400mg Oral twice daily
Liposomal DoxorubicinDrug
Also called Doxil®
50mg/m2 Monthly Intravenous
AZD2281Drug
200mg oral twice daily

Study groups in NCT00628251
Study group	Role	What they receive
1	Experimental	AZD2281 Oral 200 mg BID Receives: Drug: AZD2281
2	Active comparator	Liposomal Doxorubicin Receives: Drug: Liposomal Doxorubicin
3	Experimental	AZD2281 Oral 400 mg BID Receives: Drug: AZD2281

What is being measured

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

Progression Free Survival (PFS)
PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)
Measured: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

Secondary outcomes (10)

Objective Response Rate (ORR)
ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
Measured: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Disease Control Rate
The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) >4 months, divided by the number of randomised patients
Measured: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Overall Duration of Response
The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)
Measured: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Best Percentage Change in Tumour Size
The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication
Measured: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Best Percentage Change From Baseline in CA-125 Levels
Best percentage change in cancer antigen 125 (CA-125) levels
Measured: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Confirmed RECIST Response and/or CA-125 Response
The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.
Measured: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Overall Survival (OS)
OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals
Measured: At the time of the cut-off for the final analysis of overall survival (30 April 2010)
Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)
Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100.
Measured: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.
Measured: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Best QoL Response for FACT-O Symptom Index (FOSI)
Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.
Measured: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Timeline

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

30 Jul 200819 Sep 2018

First posted5 Mar 2008 (estimated)
Study start30 Jul 2008
Primary completion15 Sep 2009
Study completion19 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Ovarian NeoplasmsStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00628251
Sponsor's protocol ID: D0810C00012
Acronym: ICEBERG 3
Status last verified: Nov 2019
First submitted: 26 Feb 2008
Last updated: 5 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Expanded access: Available

Publications

Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
PubMed 37407274
Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
PubMed 35170751
Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidzinski M, Kim JW, Nam JH, Madry R, Hernandez C, Mora PAR, Ryu SY, Milenkova T, Lowe ES, Barker L, Scambia G. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1164-1174. doi: 10.1200/JCO.19.02745. Epub 2020 Feb 19.
PubMed 32073956
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
Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.
PubMed 19238149

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?

See locations

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RecruitingPhase 1
A Phase 1 Study to Evaluate OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
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All Ovarian Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy
ClinicalTrials.gov ID: NCT00628251
Acronym / sponsor ID: ICEBERG 3 / D0810C00012
Conditions: Ovarian Neoplasms
Keywords: Advanced ovarian cancer, BRCA1 protein, BRCA2 protein, Poly(ADP ribose) polymerases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 30 Jul 2008 (actual)
Primary completion: 15 Sep 2009 (actual)
Study completion: 19 Sep 2018 (actual)
First posted: 5 Mar 2008 (estimated)
Results: Posted 3 Jun 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: AZD2281AZD2281 Oral 200 mg BID
2	Active comparator	Drug: Liposomal DoxorubicinLiposomal Doxorubicin
3	Experimental	Drug: AZD2281AZD2281 Oral 400 mg BID

Who may qualify

Ages: 18 to 130 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Advanced ovarian cancer with positive BRCA1 or BRCA2 status
Progressive or recurrent disease after platinum-based chemotherapy
Measurable disease by RECIST

Key exclusion criteria (4 listed)

Previous anthracycline treatment
Brain metastases
Less than 28 days since last treatment used to treat the disease
Considered a poor medical risk due to a serious uncontrolled disorder

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: Olaparib400mg Oral twice daily	Drug	3
Liposomal DoxorubicinAlso: Doxil®50mg/m2 Monthly Intravenous	Drug	2
AZD2281200mg oral twice daily	Drug	1

Primary outcome

Progression Free Survival (PFS)
Time frame: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)
PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)

10 secondary outcomes

Objective Response Rate (ORR)
Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Disease Control Rate
Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Overall Duration of Response
Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Best Percentage Change in Tumour Size
Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Best Percentage Change From Baseline in CA-125 Levels
Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Confirmed RECIST Response and/or CA-125 Response
Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Overall Survival (OS)
Time frame: At the time of the cut-off for the final analysis of overall survival (30 April 2010)
Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)
Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Best QoL Response for FACT-O Symptom Index (FOSI)
Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

Results and safety

Results posted to the registry on 3 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olaparib 200 mg bd	32	32
Olaparib 400 mg bd	32	32
Liposomal Doxorubicin	33	32

Primary outcome: Progression Free Survival (PFS)

Time frame: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009). Count of participants. Unit: Participants

Measure	Olaparib 200 mg bd n = 32	Olaparib 400 mg bd n = 32	Liposomal Doxorubicin n = 33
Value	19	20	20

Olaparib 200 mg bd vs Olaparib 400 mg bd vs Liposomal Doxorubicin: Hazard Ratio (HR): 0.88 (95% CI 0.51 to 1.56), p = 0.6604, Regression, Cox
Olaparib 200 mg bd vs Liposomal Doxorubicin: Hazard Ratio (HR): 0.91 (95% CI 0.48 to 1.74), p = 0.7794, Regression, Cox
Olaparib 400 mg bd vs Liposomal Doxorubicin: Hazard Ratio (HR): 0.86 (95% CI 0.45 to 1.62), p = 0.6604, Regression, Cox

Primary outcome: Progression Free Survival (PFS)

Measure	Olaparib 200 mg bd n = 32	Olaparib 400 mg bd n = 32	Liposomal Doxorubicin n = 33
Value	6.5 (5.5 to 10.1)	8.8 (5.4 to 9.2)	7.1 (3.7 to 10.7)

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olaparib 200 mg bd	5 of 32 (15.6%)	32 of 32 (100%)	Not reported
Olaparib 400 mg bd	6 of 32 (18.8%)	32 of 32 (100%)	Not reported
Liposomal Doxorubicin	5 of 32 (15.6%)	31 of 32 (96.9%)	Not reported

Limitations and caveats (from the sponsor): The AEs reported include all events up to the OS data cut-off. After the PFS data cut-off, AEs were only collected for the olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at the time of PFS.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37407274Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
Derived from this study: PubMed 35170751Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
Derived from this study: PubMed 32073956Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidzinski M, Kim JW, Nam JH, Madry R, Hernandez C, Mora PAR, Ryu SY, Milenkova T, Lowe ES, Barker L, Scambia G. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1164-1174. doi: 10.1200/JCO.19.02745. Epub 2020 Feb 19.
Derived from this study: PubMed 26961146Matulonis 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.
Derived from this study: PubMed 23922302Ang 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.
Derived from this study: PubMed 19238149Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.
CSR\_Synopsis\_D0810C00012.pdfLink provided by the sponsor.

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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

Stan Kaye, BSc, MB, FRCP, FRCR, SMedSCi principal investigator

Royal Marsden NHS Foundation Trust

24 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2281 and Liposomal Doxorubicin in people with Ovarian Neoplasms, run by AstraZeneca at 24 sites in 9 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 4 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 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, United Kingdom, Australia, Israel, Germany and 4 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (PFS) (time frame: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)). 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 NCT00628251, which also lists 6 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 5 Dec 2019.