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Prostate CancerPhase 3SYNERGYNCT01188187

Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer

A Phase 3 study testing Custirsen, Docetaxel and Prednisone in people with Prostate Cancer, run by Achieve Life Sciences at 140 sites in 12 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 Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Custirsen, Docetaxel and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,022 participants
Where
140 sitesin 12 countries
Study dates
Nov 2010to Jun 2014
Phase
Phase 3
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years on the date of consent.
  • Histological or cytological diagnosis of adenocarcinoma of the prostate.
  • Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan.
  • Systemic chemotherapy indicated due to progression while on or after androgen ablative therapy defined as:
  • Progressive measurable disease: at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed -or- the appearance of one or more new lesions as assessed by CT scan during hormone ablation treatment. Measurable lesions are nodal or visceral soft-tissue lesions with nodal lesions ≥ 20 mm in diameter or visceral/soft-tissue lesions ≥ 10 mm in diameter (see Section 6.3.1.1 ).
  • OR
Show all 23Show fewer
  • Bone Scan Progression: appearance of 2 or more new lesions on bone scan during hormone ablation treatment.
  • OR
  • Increasing serum prostate-specific antigen (PSA) level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable. A minimum starting value of 5.0 ng/mL is required for study randomization.
  • Baseline laboratory values as stated below:
  • Creatinine ≤ 1.5 x upper limit of normal (ULN).
  • Bilirubin ≤ 1.1 x ULN (unless elevated secondary to conditions such as Gilbert's disease).
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) ≤ 1.5 x ULN.
  • Castrate serum testosterone level (< 50 ng/dL-or-< 1.7 nmol/L).
  • Must be willing to continue primary androgen suppression with gonadotropin-releasing hormone (GnRH) analogues (either agonists or antagonists) throughout the study, unless treated with bilateral orchiectomy.
  • Adequate bone marrow function defined at screening as absolute neutrophil count (ANC) ≥ 1.5 x 10^9 cells /L and platelet count ≥ 100 x 10^9 /L.
  • Karnofsky score ≥ 70% (see Appendix 17.2).
  • At least 28 days has passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of ≤ 800 centigray (cGy) to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of randomization.
  • At least 4 weeks have passed since receiving any investigational agent at the time of randomization.
  • Has recovered from any other therapy-related toxicity to ≤ grade 2, (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy).
  • Patient must be willing to not add, delete or change their current bisphosphonate or denosumab usage throughout study treatment to assure that adverse event reporting is not confounded by changing their bisphosphonate or denosumab usage (unless withdrawn or changed as a result of bisphosphonate or denosumab associated toxicity).
  • Patients receiving more than 10 mg of prednisone per day (or steroid equivalent) at screening must be willing to have the dose reduced to 10 mg of prednisone per day for at least 7 days prior to randomization and maintained throughout study treatment.
  • Written informed consent must be obtained prior to any protocol-specific procedures being performed.

Who cannot join

  • Received any other cytotoxic chemotherapy as treatment for prostate cancer.
  • Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomization with the exception of the continuous GnRH analogues required in Inclusion Criteria #6.
  • Participated in a prior clinical study evaluating custirsen.
  • History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. (Brain imaging for asymptomatic patients is not required.)
  • Current symptomatic cord compression requiring surgery or radiation therapy. (Once successfully treated and there has been no progression, patients are eligible for the study.) -Active second malignancy (except non-melanomatous skin or superficial bladder cancer) defined as requiring anticancer therapy or at high risk of recurrence during the study.
  • Active second malignancy (except non melanomatous skin or superficial bladder cancer) defined as requiring cancer therapy or at high risk of reoccurrence during the study
  • Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
  • Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.

Trial locations and contacts

140 sites in 12 countries.

140 sites in 12 countries

United States25 sites

  • Teva Investigational Site 098

    Ann Arbor, Michigan

  • Teva Investigational Site 096

    Atlanta, Georgia

  • Teva Investigational Site 103

    Baton Rough, Louisiana

  • Teva Investigational Site 100

    Birmingham, Alabama

  • Teva Investigational Site 107

    Cincinnati, Ohio

  • Teva Investigational Site 112

    Detroit, Michigan

  • Teva Investigational Site 090

    Fort Collins, Colorado

  • Teva Investigational Site 106

    Fort Myers, Florida

  • Teva Investigational Site 266

    Greensboro, South Carolina

  • Teva Investigational Site 204

    Las Vegas, Nevada

  • Teva Investigational Site 086

    Los Angeles, California

  • Teva Investigational Site 263

    Los Angeles, California

  • Teva Investigational Site 093

    Marina del Rey, California

  • Teva Investigational Site 084

    Memphis, Tennessee

  • Teva Investigational Site 102

    Myrtle Beach, South Carolina

  • Teva Investigational Site 101

    Nashville, Tennessee

  • Teva Investigational Site 047

    Newport, Virginia

  • Teva Investigational Site 104

    Norfolk, Virginia

  • Teva Investigational Site 094

    Port Saint Lucie, Florida

  • Teva Investigational Site 032

    Rochester, Minnesota

  • Teva Investigational Site 116

    San Antonio, Texas

  • Teva Investigational Site 097

    San Diego, California

  • Teva Investigational Site 029

    Seattle, Washington

  • Teva Investigational Site 059

    Tyler, Texas

  • Teva Investigational Site 063

    Tyler, Texas

Other trials in United States

Germany19 sites

  • Teva Investigational Site 607

    Aachen

  • Teva Investigational Site 609

    Berlin

  • Teva Investigational Site 613

    Berlin

  • Teva Investigational Site 604

    Darmstadt

  • Teva Investigational Site 612

    Dresden

  • Teva Investigational Site 618

    Greifswald

  • Teva Investigational Site 600

    Hanover

  • Teva Investigational Site 606

    Heidelberg

  • Teva Investigational Site 615

    Heinsberg

  • Teva Investigational Site 611

    Homburg/Saar

  • Teva Investigational Site 617

    Kempen

  • Teva Investigational Site 608

    Marburg

  • Teva Investigational Site 616

    Meiningen

  • Teva Investigational Site 614

    München

  • Teva Investigational Site 601

    Münster

  • Teva Investigational Site 602

    Nürtingen

  • Teva Investigational Site 603

    Stuttgart

  • Teva Investigational Site 610

    Tübingen

  • Teva Investigational Site 605

    Wuppertal

Other trials in Germany

Canada16 sites

  • Teva Investigational Site 118

    Abbotsford British Columbia, British Columbia

  • Teva Investigational Site 002

    Calgary, Alberta

  • Teva Investigational Site 023

    Edmonton, Alberta

  • Teva Investigational Site 028

    Halifax, Nova Scotia

  • Teva Investigational Site 025

    Hamilton, Ontario

  • Teva Investigational Site 108

    Kingston, Ontario

  • Teva Investigational Site 026

    Montreal, Quebec

  • Teva Investigational Site 027

    Montreal, Quebec

  • Teva Investigational Site 091

    Oshawa, Ontario

  • Teva Investigational Site 003

    Ottawa, Ontario

  • Teva Investigational Site 007

    Surrey, British Columbia

  • Teva Investigational Site 004

    Toronto, Ontario

  • Teva Investigational Site 087

    Toronto, Ontario

  • Teva Investigational Site 001

    Vancouver, British Columbia

  • Teva Investigational Site 085

    Victoria, British Columbia

  • Teva Investigational Site 024

    Winnipeg, Manitoba

Other trials in Canada

Spain16 sites

  • Teva Investigational Site 803

    Barcelona

  • Teva Investigational Site 808

    Barcelona

  • Teva Investigational Site 809

    Barcelona

  • Teva Investigational Site 816

    Dos Hermanas

  • Teva Investigational Site 814

    El Palmar

  • Teva Investigational Site 807

    Guadalajara

  • Teva Investigational Site 800

    Madrid

  • Teva Investigational Site 801

    Madrid

  • Teva Investigational Site 806

    Madrid

  • Teva Investigational Site 813

    Madrid

  • Teva Investigational Site 815

    Manresa

  • Teva Investigational Site 810

    Murcia

  • Teva Investigational Site 811

    Palma de Mallorca

  • Teva Investigational Site 805

    Pamplona

  • Teva Investigational Site 804

    Sabadell - Barcelona

  • Teva Investigational Site 802

    Valencia

Other trials in Spain

France14 sites

  • Teva Investigational Site 551

    Angers

  • Teva Investigational Site 552

    Avignon

  • Teva Investigational Site 553

    Grenoble

  • Teva Investigational Site 555

    La Roche-sur-Yon

  • Teva Investigational Site 557

    Marseille

  • Teva Investigational Site 558

    Nice

  • Teva Investigational Site 559

    Paris

  • Teva Investigational Site 560

    Paris

  • Teva Investigational Site 566

    Saint-Brieuc

  • Teva Investigational Site 561

    Saint-Herblain

  • Teva Investigational Site 562

    Saint-Priest-en-Jarez

  • Teva Investigational Site 563

    Toulouse

  • Teva Investigational Site 564

    Vandœuvre-lès-Nancy

  • Teva Investigational Site 550

    Villejuif

Other trials in France

Italy14 sites

  • Teva Investigational Site 753

    Arezzo

  • Teva Investigational Site 758

    Catanzaro

  • Teva Investigational Site 760

    Cesena (FC)

  • Teva Investigational Site 752

    Genova

  • Teva Investigational Site 755

    Lugo (Ravenna)

  • Teva Investigational Site 759

    Meldola (FC)

  • Teva Investigational Site 763

    Milan

  • Teva Investigational Site 754

    Naples

  • Teva Investigational Site 756

    Naples

  • Teva Investigational Site 761

    Rimini

  • Teva Investigational Site 750

    Roma

  • Teva Investigational Site 762

    Roma

  • Teva Investigational Site 764

    Rozzano (MI)

  • Teva Investigational Site 765

    Verona

Other trials in Italy

Hungary9 sites

  • Teva Investigational Site 691

    Budapest

  • Teva Investigational Site 694

    Budapest

  • Teva Investigational Site 692

    Debrecen

  • Teva Investigational Site 697

    Debrecen

  • Teva Investigational Site 696

    Győr

  • Teva Investigational Site 698

    Miskolc

  • Teva Investigational Site 699

    Nyíregyháza

  • Teva Investigational Site 693

    Szeged

  • Teva Investigational Site 695

    Veszprém

Other trials in Hungary

South Korea7 sites

  • Teva Investigational Site 404

    Cheongju,Chungbuk

  • Teva Investigational Site 401

    Goyang-si Gyeonggi-do

  • Teva Investigational Site 400

    Seoul

  • Teva Investigational Site 402

    Seoul

  • Teva Investigational Site 403

    Seoul

  • Teva Investigational Site 406

    Seoul

  • Teva Investigational Site 405

    Yangsan

Other trials in South Korea

United Kingdom7 sites

  • Teva Investigational Site 704

    Brighton

  • Teva Investigational Site 701

    Cambridge

  • Teva Investigational Site 709

    Coventry

  • Teva Investigational Site 705

    Guildford, Surrey

  • Teva Investigational Site 703

    Manchester

  • Teva Investigational Site 710

    Metropolitan Borough of Wirral

  • Teva Investigational Site 700

    Surrey

Other trials in United Kingdom

Israel6 sites

  • Teva Investigational Site 507

    Haifa

  • Teva Investigational Site 506

    Jerusalem, IL

  • Teva Investigational Site 505

    Petah Tikva

  • Teva Investigational Site 502

    Ramat Gan

  • Teva Investigational Site 503

    Tel Aviv

  • Teva Investigational Site 501

    Zrifin

Other trials in Israel

Belgium4 sites

  • Teva Investigational Site 862

    Bonheiden

  • Teva Investigational Site 860

    Brussels

  • Teva Investigational Site 864

    Edegem

  • Teva Investigational Site 863

    Ghent

Other trials in Belgium

Netherlands3 sites

  • Teva Investigational Site 851

    Amsterdam

  • Teva Investigational Site 852

    Rotterdam

  • Teva Investigational Site 853

    Sittard-Geleen

Other trials in Netherlands

About this study

Official title: A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer

This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms.

Conditions
Prostate Cancer
Being tested
Custirsen, Docetaxel, Prednisone, Dexamethasone
Keywords
custirsen sodium, prostate cancer, overall survival, Metastatic Castrate Resistant Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • CustirsenDrug

    Also called OGX-011

  • DocetaxelDrug

  • PrednisoneDrug

  • DexamethasoneDrug

    Dexamethasone 8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration to reduce the incidence and severity of hypersensitivity reactions and fluid retention.

Study groups in NCT01188187
Study groupRoleWhat they receive
Custirsen, Docetaxel, PrednisoneExperimentalThree doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
Receives: Drug: Custirsen; Drug: Docetaxel; Drug: Prednisone; Drug: Dexamethasone
Docetaxel, PrednisoneActive comparatorDocetaxel (75 mg/M^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
Receives: Drug: Docetaxel; Drug: Prednisone; Drug: Dexamethasone

What is being measured

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

  1. Kaplan-Meier Estimates for Time to Death (Overall Survival)

    Time from the date of randomization to death from any cause. After stopping treatment, patients were followed every 4 weeks until disease progression and then followed every 12 weeks until death.

    Measured: Randomization (approximately Day -12) to longest survival follow-up (Day 971).

Secondary outcomes (2)

  1. Percentage of Participants Who Were Alive Without Event At Day 140

    Patients who were alive without event (AWE) are patients who had their Milestone Day 140 Disease Status performed per protocol (Day 125 - Day 155 window), were not determined to have disease progression by the investigator on that window and confirmed as not having progressive disease (NONPD) by the Central Imagine Lab independent review.

    Measured: Day 125-155

  2. Percentage of Participants with Adverse Events

    An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the administration, at any dose, of a medicinal or therapeutic product whether or not considered related to that product. Severity was rated by the investigator on a scale of 1 (mild) to 5 (death). A severity of 3 = Severe or medically significant but not immediately life-threatening. A severity of 4 = Life-threatening. Serious AEs include death (death due to progressive disease were not reported as an SAE), a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

    Measured: Docetaxel/prednisone/custirsen arm: Days -9 up to Day 743. Docetaxel/prednisone arm: Day 1 up to Day 400.

Timeline

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

  1. First posted25 Aug 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionFeb 2014
  4. Study completionJun 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,022 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01188187
Sponsor's protocol ID
OGX-011-11 TRANSFERRED
Acronym
SYNERGY
Status last verified
Oct 2016
First submitted
23 Aug 2010
Last updated
14 Oct 2016
Results posted
No

Publications

  • Chi KN, Higano CS, Blumenstein B, Ferrero JM, Reeves J, Feyerabend S, Gravis G, Merseburger AS, Stenzl A, Bergman AM, Mukherjee SD, Zalewski P, Saad F, Jacobs C, Gleave M, de Bono JS. Custirsen in combination with docetaxel and prednisone for patients with metastatic castration-resistant prostate cancer (SYNERGY trial): a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2017 Apr;18(4):473-485. doi: 10.1016/S1470-2045(17)30168-7. Epub 2017 Mar 8.

    PubMed 28283282

  • de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

    PubMed 24722180

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Custirsen, Docetaxel and Prednisone in people with Prostate Cancer, run by Achieve Life Sciences at 140 sites in 12 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 23 inclusion and 8 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Germany, Canada, Spain, France and 7 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?

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?

Kaplan-Meier Estimates for Time to Death (Overall Survival) (time frame: Randomization (approximately Day -12) to longest survival follow-up (Day 971).). 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 NCT01188187, which also lists 2 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 14 Oct 2016.

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