LymphomaPhase 3OPTIMALNCT00117598

Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)

A Phase 3 study testing Temsirolimus (CCI-779) and Investigator's choice in people with Lymphoma, run by Pfizer at 73 sites in 18 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

This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma
What is being tested?: Temsirolimus (CCI-779) and Investigator's choice
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 169 participants
Where: 73 sitesin 18 countries
Study dates: May 2005to Jan 2011
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1 analysis
Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant (i.e. induction + consolidation + maintenance)
Prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following:
Primary disease refractory to at least 2 regimens;
Refractory to at least 1 regimen after first relapse;
Refractory or untreated after second or greater relapse;
Refractory to first line and relapsed after second line. Chemotherapy combinations may include, but are not limited to: CHOP (Cyclophosphamide, doxorubicin, vincristine, prednisone), R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, prednisone), FCM (Fludarabine, cyclophosphamide, mitoxantrone), R-FCM (Rituximab,Fludarabine, cyclophosphamide, mitoxantrone), ICE(Ifosfamide, carboplatin, etoposide), DHAP (Dexamethasone, cisplatin, cytarabine) and hyper-CVAD (Cyclophosphamide, doxorubicin, vincristine, dexamethasone).

Who cannot join

Subjects who are less than or equal to six month from allogeneic hematopoietic stem cell transplant and who are on immunosuppressive therapy or have evidence of graft versus host disease
Prior investigational therapy within 3 weeks of first dose. Investigational therapy is defined as treatment that is not approved for any indication.
Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated CNS metastases must be stable for > 2 weeks prior to Day 1.)

Trial locations and contacts

73 sites in 18 countries.

Country

City, postcode or hospital

73 sites in 18 countries

United States19 sites

Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Boca Raton, Florida, 33428
Pfizer Investigational Site
Buffalo, New York, 14263
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Fountain Valley, California, 92708
Pfizer Investigational Site
Grapevine, Texas, 76051
Pfizer Investigational Site
Honolulu, Hawaii, 96813
Pfizer Investigational Site
Houston, Texas, 77030-4009
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Los Angeles, California, 90024-2828
Pfizer Investigational Site
Morristown, New Jersey, 07960
Pfizer Investigational Site
New Milford, Connecticut, 06776
Pfizer Investigational Site
New York, New York, 10029-6574
Pfizer Investigational Site
Portland, Oregon, 97227
Pfizer Investigational Site
Rochester, New York, 14642-8668
Pfizer Investigational Site
Seattle, Washington, 98101
Pfizer Investigational Site
Temple, Texas, 76508
Pfizer Investigational Site
Upland, Pennsylvania, 19013
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007

Other trials in United States

Canada8 sites

Pfizer Investigational Site
Edmonton, Alberta, T6G 1Z2
Pfizer Investigational Site
Greenfield Park, Quebec, J4V 2H1
Pfizer Investigational Site
London, Ontario, N6A 4L5
Pfizer Investigational Site
Montreal, Quebec, H1T2M4
Pfizer Investigational Site
Montreal, Quebec, H4J 1C5
Pfizer Investigational Site
Ottawa, Ontario, K1H 8L6
Pfizer Investigational Site
Toronto, Ontario, M5G 2C4
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

France6 sites

Pfizer Investigational Site
Lyon, 69008
Pfizer Investigational Site
Paris, 75475
Pfizer Investigational Site
Paris, 75747
Pfizer Investigational Site
Pierre-Bénite, 69495
Pfizer Investigational Site
Strasbourg, 67098
Pfizer Investigational Site
Villejuif, 94805

Other trials in France

China5 sites

Pfizer Investigational Site
Beijing, 100021
Pfizer Investigational Site
Beijing, 100036
Pfizer Investigational Site
Shanghai, 2000025
Pfizer Investigational Site
Shanghai, 200032
Pfizer Investigational Site
Shanghai, 200433

Other trials in China

Spain5 sites

Pfizer Investigational Site
Barcelona, Barcelona, 08035
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Madrid, 28006
Pfizer Investigational Site
Pamplona, Navarre, 31008

Other trials in Spain

Belgium4 sites

Pfizer Investigational Site
Bruges, 8000
Pfizer Investigational Site
Ghent, Belgium, 9000
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000

Other trials in Belgium

Germany4 sites

Pfizer Investigational Site
Heidelberg, 69120
Pfizer Investigational Site
Mainz, 55131
Pfizer Investigational Site
Ulm, Baden-Wurttemberg, 89070
Pfizer Investigational Site
Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Italy4 sites

Pfizer Investigational Site
Bologna, Italy, 40128
Pfizer Investigational Site
Catania, 95124
Pfizer Investigational Site
Milan, 20132
Pfizer Investigational Site
Roma, Italy, 00161

Other trials in Italy

United Kingdom4 sites

Pfizer Investigational Site
Plymouth, Devon, PL6 8DH
Pfizer Investigational Site
Southampton, Hants, SO16 6YD
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT
Pfizer Investigational Site
Tooting, London, SW17 0QT

Other trials in United Kingdom

Argentina3 sites

Pfizer Investigational Site
Buenos Aires, Buenos Aires, C1406FWZ
Pfizer Investigational Site
Buenos Aires, C1405BWU
Pfizer Investigational Site
Córdoba, Córdoba Province, 5000

Other trials in Argentina

Brazil2 sites

Pfizer Investigational Site
Porto Alegre - RS, 90610-000
Pfizer Investigational Site
Vila Buarque, São Paulo, 01221-010

Other trials in Brazil

Poland2 sites

Pfizer Investigational Site
Lublin, 20-081
Pfizer Investigational Site
Warsaw, 02-781

Other trials in Poland

Sweden2 sites

Pfizer Investigational Site
Lund, 221 85
Pfizer Investigational Site
Uppsala, 751 85

Other trials in Sweden

Australia1 site

Pfizer Investigational Site
East Melbourne, Victoria, 3000

Other trials in Australia

Austria1 site

Pfizer Investigational Site
Vienna, A-1090

Other trials in Austria

Chile1 site

Pfizer Investigational Site
Providencia, Santiago Metropolitan

Other trials in Chile

Netherlands1 site

Pfizer Investigational Site
Rotterdam, 3015 GD

Other trials in Netherlands

Switzerland1 site

Pfizer Investigational Site
Aarau, 5001

Other trials in Switzerland

About this study

Official title: An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus (CCI-779) At Two Dose Levels Compared To Investigator's Choice Therapy In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)

This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).

Conditions: Lymphoma
Being tested: Temsirolimus (CCI-779), Investigator's choice
Keywords: Lymphoma
Medical subject headings: Lymphoma

What participants receive

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

Temsirolimus (CCI-779)Drug
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week
Temsirolimus (CCI-779)Drug
Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week
Investigator's choiceDrug
Any of the following single agent treatments:
1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate.
2. Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days
3. Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days
4. Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days
5. Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
6. Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days
7. Prednisone 40 (20-60) mg/m2 PO daily or every other day
8. Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day

Study groups in NCT00117598
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Temsirolimus (CCI-779)
B	Experimental	Not described Receives: Drug: Temsirolimus (CCI-779)
C	Active comparator	Not described Receives: Drug: Investigator's choice

What is being measured

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

Progression-Free Survival (PFS)
The period from randomization until disease progression, death or date of last contact.
Measured: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

Secondary outcomes (1)

Percentage of Participants With Objective Response
Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ↓ size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ↑ number or aggregate size, no cytologic/architectural atypia. PR: ≥50% ↓ index lesion, no size ↑ in other nodes, liver, spleen. Splenic and hepatic nodule regressed ≥50%. No new disease.
Measured: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

Timeline

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

May 2005Jan 2011

First posted7 Jul 2005 (estimated)
Study startMay 2005
Primary completionAug 2007
Study completionJan 2011

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 (1)Papers the sponsor has linked to this study.
Other trials for LymphomaStudies of the same condition, open and under way.
More trials run by PfizerThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00117598
Sponsor's protocol ID: 3066K1-305
Acronym: OPTIMAL
Status last verified: Mar 2015
First submitted: 30 Jun 2005
Last updated: 30 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hess G, Coiffier B, Crump M, Gisselbrecht C, Offner F, Romaguera J, Kang L, Moran PJ. Effect of prognostic classification on temsirolimus efficacy and safety in patients with relapsed or refractory mantle cell lymphoma: a retrospective analysis. Exp Hematol Oncol. 2015 Apr 11;4:11. doi: 10.1186/s40164-015-0006-1. eCollection 2015.
PubMed 25938001

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

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative

All Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus (CCI-779) At Two Dose Levels Compared To Investigator's Choice Therapy In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)
ClinicalTrials.gov ID: NCT00117598
Acronym / sponsor ID: OPTIMAL / 3066K1-305
Conditions: Lymphoma
Keywords: Lymphoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Aug 2007 (actual)
Study completion: Jan 2011 (actual)
First posted: 7 Jul 2005 (estimated)
Results: Posted 6 Mar 2012

Clinical summary

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

This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).

Study design

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

Arm	Type	Receives
A	Experimental	Drug: Temsirolimus (CCI-779)
B	Experimental	Drug: Temsirolimus (CCI-779)
C	Active comparator	Drug: Investigator's choice

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1 analysis
Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant (i.e. induction + consolidation + maintenance)
Prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following:
Primary disease refractory to at least 2 regimens;
Refractory to at least 1 regimen after first relapse;

Key exclusion criteria (3 listed)

Subjects who are less than or equal to six month from allogeneic hematopoietic stem cell transplant and who are on immunosuppressive therapy or have evidence of graft versus host disease
Prior investigational therapy within 3 weeks of first dose. Investigational therapy is defined as treatment that is not approved for any indication.
Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated CNS metastases must be stable for > 2 weeks prior to Day 1.)

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
Temsirolimus (CCI-779)Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week	Drug	A
Temsirolimus (CCI-779)Temsirolimus 175 mg IV once a week for 3 weeks; followed by 25 mg IV once a week	Drug	B
Investigator's choiceAny of the following single agent treatments: 1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate. 2. Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days 3. Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days 4. Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days 5. Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response, 6. Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days 7. Prednisone 40 (20-60) mg/m2 PO daily or every other day 8. Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day	Drug	C

Primary outcome

Progression-Free Survival (PFS)
Time frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)
The period from randomization until disease progression, death or date of last contact.

1 secondary outcome

Percentage of Participants With Objective Response
Time frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

Results and safety

Results posted to the registry on 6 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Temsirolimus 175/75 mg	57	0
Temsirolimus 175/25 mg	56	3
Investigator's Choice	56	4
Temsirolimus 175/25 mg Then 75 mg	0	0
Investigator's Choice Then Temsirolimus 175/75 mg	0	0

Primary outcome: Progression-Free Survival (PFS)

Time frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5). Median (95% Confidence Interval). Unit: months

Measure	Temsirolimus 175/75 mg n = 54	Temsirolimus 175/25 mg n = 54	Investigator's Choice n = 54
Value	4.8 (2.9 to 7.0)	3.7 (3.4 to 6.2)	1.8 (1.6 to 2.0)

Temsirolimus 175/75 mg vs Investigator's Choice: Hazard Ratio (HR): 0.39 (95% CI 0.25 to 0.63), p <0.0001, Log Rank
Temsirolimus 175/25 mg vs Investigator's Choice: Hazard Ratio (HR): 0.41 (95% CI 0.26 to 0.65), p <0.0001, Log Rank

Population analysed: Intent-to-Treat (ITT) Population: All randomized participants at time of primary analysis

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Temsirolimus 175/75 mg	34 of 57 (59.6%)	57 of 57 (100%)	Not reported
Temsirolimus 175/25 mg	34 of 56 (60.7%)	56 of 56 (100%)	Not reported
Investigator's Choice	14 of 54 (25.9%)	52 of 54 (96.3%)	Not reported
Temsirolimus 175/25 mg Then 75 mg	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Investigator's Choice Then Temsirolimus 175/75 mg	1 of 4 (25%)	4 of 4 (100%)	Not reported

Limitations and caveats (from the sponsor): After the primary analysis was completed, efficacy data was no longer collected nor analyzed; Participants were followed for safety up to 6 months after the last dose of temsirolimus.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25938001Hess G, Coiffier B, Crump M, Gisselbrecht C, Offner F, Romaguera J, Kang L, Moran PJ. Effect of prognostic classification on temsirolimus efficacy and safety in patients with relapsed or refractory mantle cell lymphoma: a retrospective analysis. Exp Hematol Oncol. 2015 Apr 11;4:11. doi: 10.1186/s40164-015-0006-1. eCollection 2015.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Lymphoma

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative

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.

Pfizer CT.gov Call Center study director

Pfizer

73 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Temsirolimus (CCI-779) and Investigator's choice in people with Lymphoma, run by Pfizer at 73 sites in 18 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 7 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 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Canada, France, China, Spain and 13 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 6 Mar 2012). 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: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)). 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 NCT00117598, which also lists 1 linked publication.

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 30 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.