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Urologic NeoplasmsPhase 2NCT01454089

A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer

A Phase 2 study testing OGX-427 600 mg, OGX-427 1000 mg and Gemcitabine in people with Urologic Neoplasms and Metastatic Bladder Cancer, run by Achieve Life Sciences at 55 sites in 7 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 primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
OGX-427 600 mg, OGX-427 1000 mg and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
183 participants
Where
55 sitesin 7 countries
Study dates
Oct 2011to Nov 2014
Phase
Phase 2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at the time of consent
  • Histologically documented metastatic or locally inoperable advanced transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3 or M1 disease) NOTE: Certain mixed histologies that are predominately (≥ 50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires immunohistochemistry (IHC) consistent with a TCC origin. Mixed small-cell histologies are excluded
  • Measurable disease defined as at least one target lesion that has not been irradiated and can be accurately measured in at least one dimension by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • No prior systemic chemotherapy with the following exceptions:
  • Prior use of radiosensitizing single agent therapy is allowed
  • Prior neoadjuvant and adjuvant chemotherapy may be allowed
Show all 16Show fewer
  • Minimum of 21 days since prior major surgery or radiation therapy
  • Karnofsky performance status ≥ 70%
  • Required laboratory values at baseline:
  • absolute neutrophil count (ANC) ≥ 1.5 x 10^9 cells/L
  • platelet count ≥ 125 x 10^9/L
  • calculated creatinine clearance ≥ 60 mL/minute
  • bilirubin ≤ 1.5 x upper limit of normal (ULN; ≤ 2.5 x ULN if secondary to Gilbert's disease)
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN
  • If of child-bearing potential, willing to use contraceptives
  • Willing to give written informed consent

Who cannot join

  • A candidate for potential curative surgery or radiotherapy
  • Intravesical therapy within the last 3 months
  • Documented brain metastasis or carcinomatous meningitis, treated or untreated. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of central nervous system (CNS) disease.
  • Peripheral neuropathy ≥ Grade 2
  • Known serious hypersensitivity to gemcitabine, cisplatin or carboplatin
  • Current serious, uncontrolled medical condition such as congestive heart failure, angina, hypertension, arrhythmia, diabetes mellitus, infection, etc. or any condition such as a psychiatric illness which in the opinion of the investigator would make the patient unacceptable for the protocol
Show all 10Show fewer
  • Cerebrovascular accident, myocardial infarction or pulmonary embolus within 6 months of randomization
  • Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (> 30%) of recurrence during the study
  • Pregnant or nursing (must have a negative serum or urine pregnancy test within 72 hours prior to randomization)
  • Participating in a concurrent clinical trial of an experimental drug, vaccine or device. Participation in an observational study is allowed

Trial locations and contacts

55 sites in 7 countries.

55 sites in 7 countries

United States14 sites

  • Texas Oncology, P.A.

    Dallas, Texas

  • Karmanos Cancer Institute

    Detroit, Michigan

  • City of Hope National Medical Center

    Duarte, California

  • Monter Cancer Center

    Lake Success, New York

  • Cedars-Sinai Medical Center

    Los Angeles, California

  • University of California Los Angeles

    Los Angeles, California

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California

  • Yale University

    New Haven, Connecticut

  • Columbia University Medical Center

    New York, New York

  • Urology Cancer Center and GU Research Network

    Omaha, Nebraska

  • Radiological Associates of Sacramento

    Sacramento, California

  • Seattle Cancer Care Alliance

    Seattle, Washington

  • Siteman Cancer Center, Washington University School of Medicine

    St Louis, Missouri

  • Montefiore Medical Center, Albert Einstein College of Medicine

    The Bronx, New York

Other trials in United States

Germany9 sites

  • Universitätsklinikum Dresden

    Dresden, Saxony

  • Johann-Wolfgang-Goethe-Universität Frankfurt

    Frankfurt am Main, Hesse

  • Medizinische Hochschule Hannover

    Hanover, Niedeersachen

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg

  • Universitätsklinikum des Saarlandes

    Homburg, Saarland

  • Universitätsklinikum Jena

    Jena, Thuringia

  • Universitätsklinikum Magdeburg A.ö.R.

    Magdeburg, Saxony-Anhalt

  • Universitätsklinikum Mainz

    Mainz

  • Klinikum Rechts der Isar der Technischen Universität

    München, Bavaria

Other trials in Germany

France8 sites

  • Centre Paul Papin

    Angers, Pays de la Loire Region

  • Centre Hospitalier Régional et Universitaire - Hôpital

    Bretonneau Tours, Centre-Val de Loire

  • Institut Paoli Calmettes

    Marseille, Provence-Alpes-Côte d'Azur Region

  • Centre Antoine Lacassagne

    Nice, Provence-Alpes-Côte d'Azur Region

  • Institute Jean Godinot

    Reims, Champagne-Ardenne

  • Centre Hospitalier Universitaire de Rouen

    Rouen, Haute-Normandie

  • Medicale Centre René Gauducheau

    Saint-Herblain, Pays de la Loire Region

  • Centre Hospitalier Universitaire, Institut Gustave Roussy

    Villejuif, Île-de-France Region

Other trials in France

Spain8 sites

  • Hospital Santa Creu i Sant Pau

    Barcelona, Barcelona

  • Hospital Clinic I Provincial de Barcelona

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Vall d´Hebrón

    Barcelona

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid

  • Institut Català D'Oncologia, Hospital Duran i Reynals

    Madrid

  • Instituto Valenciano de Oncología-Fundación (IVO-FINCIVO)

    Valencia

Other trials in Spain

Canada7 sites

  • Tom Baker Cancer Center

    Calgary, Alberta

  • Cross Cancer Center

    Edmonton, Alberta

  • Juravinski Cancer Centre

    Hamilton, Ontario

  • CHUM-Hospital Notre Dame

    Montreal, Quebec

  • R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health

    Oshawa, Ontario

  • Princess Margaret Hospital

    Toronto, Ontario

  • British Columbia Cancer Agency

    Vancouver, British Columbia

Other trials in Canada

Poland6 sites

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship

  • Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, Warminski-Mazurskie

  • NZOZ Europejskie Centrum Zdrowia Otwock

    Otwock, Masovian Voivodeship

  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

    Warsaw, Masovian Voivodeship

  • Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship

Other trials in Poland

Italy3 sites

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    Modena

  • Fondazione IRCCS Policlinico San Matteo Pavia

    Pavia

  • Unità Operativa di Oncologia Medica

    Roma

Other trials in Italy

About this study

Official title: A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination With OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma

The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.

Read the detailed description

Following 3 loading doses, participants receive chemotherapy and study drug on a 21-day cycle during the Treatment Period (Chemotherapy Period) until disease progression, completion of 6 cycles, toxicity or voluntary participant withdrawal. Participants who do not have documented disease progression and have completed a minimum of four cycles of chemotherapy continue to receive weekly Study Drug maintenance therapy during the Maintenance Period until disease progression or the participant fulfills one of the other reasons for withdrawal from protocol treatment, unless they have been discontinued from protocol treatment for unacceptable toxicity related to study drug. All participants have an End of Treatment (EOT) visit when they are withdrawn from all study treatment (chemotherapy and maintenance). All participants are followed until documented disease progression. Once disease progression is documented, participants enter a Survival Follow-up Period during which data are collected regarding further cancer therapy, secondary malignancy, and survival status.

Being tested
OGX-427 600 mg, OGX-427 1000 mg, Placebo, Gemcitabine, Cisplatin
Keywords
bladder, urinary tract, transitional cell carcinoma, metastatic bladder cancer, chemotherapy
Medical subject headings
Urologic Neoplasms, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell

What participants receive

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

  • OGX-427 600 mgDrug

    Also called apatorsen

    Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (600 mg IV) on Days 1, 8 and 15 of each 21-day cycle.

  • OGX-427 1000 mgDrug

    Also called apatorsen

    Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (1000 mg IV) on Days 1, 8 and 15 of each 21-day cycle.

  • PlaceboDrug

    Patients will receive three loading doses of placebo within a 9-day period. Following the loading dose period, patients will receive weekly placebo infusions (IV) on Days 1, 8 and 15 of each 21-day cycle.

  • GemcitabineDrug

    Patients will receive gemcitabine (1000 mg/m^2) for up to 6 cycles administered IV on Days 1 and 8 of each 21-day cycle following Study Drug infusion. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.

  • CisplatinDrug

    Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m^2) will be administered IV for up to 6 cycles. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.

  • CarboplatinDrug

    Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m^2) is to be administered IV for up to 6 cycles; however, carboplatin could be substituted for cisplatin for some unacceptable toxicities. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.

Study groups in NCT01454089
Study groupRoleWhat they receive
OGX-427 600 mgExperimentalStandard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (600 mg)
Receives: Drug: OGX-427 600 mg; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin
OGX-427 1000 mgExperimentalStandard chemotherapy (gemcitabine and cisplatin) in combination with OGX-427 (1000 mg)
Receives: Drug: OGX-427 1000 mg; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin
PlaceboActive comparatorStandard chemotherapy (gemcitabine and cisplatin) in combination with placebo
Receives: Drug: Placebo; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin

What is being measured

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

  1. Overall Survival (OS)

    OS is defined as the time from randomization to death from any cause; OS was censored on date of last contact for participants still alive at time of analysis.

    Measured: Baseline to date of death by any cause (up to approximately 12 months)

Secondary outcomes (12)

  1. Number of Participants With Treatment-emergent Adverse Events (AEs), Serious AEs, and Grade 3 or Higher AEs

    Treatment-emergent AEs are defined as and AE that occurred after the first dose of study drug up to 30 days after the last dose of study drug. AEs were graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Treatment-emergent AEs could have occurred during loading dose period, chemotherapy period, maintenance period, and treatment period A detailed summary of adverse events is located in the Reported Adverse Event Module.

    Measured: From initiation of study drug to end of study (up to 8 months)

  2. Number of Participants With ≥ 1 Hematology Abnormality and ≥ 1 Grade 3 or Higher Hematology Abnormality

    Measured: Screening through End of Study Visit (Within 30 [±7] days following withdrawal of study treatment)

  3. Number of Participants With ≥ 1 Chemistry Laboratory Abnormality and ≥ 1 Grade 3 or Higher Chemistry Laboratory Abnormality

    Measured: Screening through End of Study Visit (Within 30 [±7] days following withdrawal of study treatment)

  4. Number of Participants With ≥ 1 Urinalysis Abnormality and ≥ 1 Grade 3 or Higher Urinalysis Abnormality

    Measured: Screening through End of Study Visit (Within 30 [±7] days following withdrawal of study treatment)

  5. Best Objective Tumor Response

    Complete Response (CR): Complete disappearance of all measurable and non-measurable disease with no new lesions. Any pathological lymph node (target or non-target) must have a reduction in short axis to < 10 mm). All markers of disease must have normalized. Partial Response (PR): A decrease from baseline of ≥ 30% of the diameter(s) of all target measurable lesions with no unequivocal progression of non-measurable lesions and no new lesions. Stable Disease (SD): Does not qualify for CR, PR, or progression. Disease Progression (PD): If at least one of following criteria is met: 1. Appearance of any new lesion or site of disease. 2. A 20% increase in the sum of the diameter(s) of target measurable lesions over either the smallest sum observed or over baseline if no decrease during therapy has occurred. The sum must also demonstrate an absolute increase of at least 5 mm. 3. Unequivocal progression of non-target lesions alone.

    Measured: Baseline to measured progressive disease (up to approximately 12 months)

  6. Overall Response Rate (ORR) and Disease Control Rate

    Participants were defined as having an "overall response" if their best response is either confirmed CR, confirmed PR, unconfirmed CR or unconfirmed PR. ORR was defined as the percent of participants who had an overall response. Participants were defined as having "disease control" if their best response is confirmed CR, confirmed PR, unconfirmed CR, unconfirmed PR or SD. The disease control rate (DCR) was defined as the percent of participants with disease control. (See "Best Objective Tumor Response" Outcome Measure above for response category definitions.)

    Measured: Baseline to measured progressive disease (up to approximately 12 months)

  7. Duration of Overall Response Rate

    Overall response was defined has having a response of Complete Response (CR) or Partial Response (PR). (See "Best Objective Tumor Response" Outcome Measure above for response category definitions.) Duration of Response is defined as the duration from the first overall response to the first Stable Disease (SD) or Disease Progression (PD), whichever happens first. If no SD or PD, subject is censored at the last tumor assessment (prior to other anti-cancer therapy if applicable).

    Measured: Baseline to measured progressive disease (up to approximately 12 months)

  8. Progression-free Survival (PFS)

    PFS was defined as the time from randomization to the date of disease progression or death, whichever occurred first, before or after treatment discontinuation. For participants still on study and those who remained alive and had not progressed after treatment discontinuation, PFS was censored on the date of the last tumor assessment.

    Measured: Baseline to measured progressive disease (up to approximately 12 months)

  9. Change From Baseline in Serum Hsp27 levels by End of Treatment

    End of Treatment is last non-hemolyzed observation up to last dose + 30 days. Includes unscheduled and additional treatment visits. Hemolyzed samples were excluded.

    Measured: Baseline, End of Treatment (up to approximately 12 months)

  10. Change From Baseline in Serum Clusterin Levels by End of Treatment

    End of Treatment is last observation up to last dose + 30 days. Includes unscheduled and additional treatment visits.

    Measured: Baseline, End of Treatment (up to approximately 12 months)

  11. Change From Baseline in Circulating Tumor Cell (CTC) Count by End of Treatment

    End of Treatment is last observation up to last dose + 30 days. Includes unscheduled and additional treatment visits.

    Measured: Baseline, End of Treatment (up to approximately 12 months)

  12. Serum OGX-427 Cmax and Trough Levels

    only C1 to C6, Ctrough and Cmax - as well report EOT Ctrough

    Measured: Cycle 1 Day 1 through Cycle 6 Day 1, End of Treatment (up to approximately 12 months)

Timeline

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

  1. First posted18 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionNov 2014
  4. Study completionNov 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01454089
Sponsor's protocol ID
OGX-427-02
Status last verified
Oct 2016
First submitted
5 Oct 2011
Last updated
7 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OGX-427 600 mg, OGX-427 1000 mg and Gemcitabine in people with Urologic Neoplasms and Metastatic Bladder Cancer, run by Achieve Life Sciences at 55 sites in 7 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 16 inclusion and 10 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 7 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 55 sites in United States, Germany, France, Spain, Canada and 2 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?

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?

Overall Survival (OS) (time frame: Baseline to date of death by any cause (up to approximately 12 months)). 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 NCT01454089.

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 7 Oct 2016.

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