Trial record 7 of 9 for:    ogx-427

Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hoosier Cancer Research Network
Sponsor:
Collaborator:
OncoGenex Technologies
Information provided by (Responsible Party):
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT01780545
First received: January 25, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

This is a randomized, open-label Phase 2 clinical trial to evaluate whether suppression of Hsp27 (Heat shock protein 27) production using OGX-427, a second-generation antisense oligonucleotide (ASO), in combination with docetaxel can prolong survival time compared to docetaxel alone in participants with locally advanced or metastatic urothelial carcinoma (UC) that are relapsed or refractory after receiving a platinum-containing regimen.


Condition Intervention Phase
Bladder Cancer
Urothelial Carcinoma
Drug: OGX-427
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Borealis-2 Clinical Trial: A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Combination With OGX-427 in Patients With Relapsed or Refractory Metastatic Urothelial Carcinoma After Receiving a Platinum-containing Regimen: Hoosier Oncology Group GU12-160

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
    To determine whether docetaxel administered in combination with OGX-427 provides a survival benefit compared to docetaxel alone.


Secondary Outcome Measures:
  • Safety and Toxicity of Regimen [ Time Frame: Every week ] [ Designated as safety issue: Yes ]
    To compare the safety and toxicity of OGX-427 in combination with docetaxel to that of docetaxel alone. Treatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0

  • Overall Response Rate [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
    To compare overall response rate (ORR) between the treatment arms.

  • Serum Levels of Hsp27 and Other Proteins [ Time Frame: Each cycle ] [ Designated as safety issue: No ]
    To evaluate the effect of therapy with docetaxel and OGX-427 on serum Hsp27 levels and other serum proteins and explore their relation with clinical outcomes.

  • Hsp27 Expression in Archival Tissue [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ]
    To evaluate the association of urothelial carcinoma expression of Hsp27 measured by immunohistochemistry (IHC) in archival tissue with clinical outcomes.

  • Effect of Therapy Regimen on Circulating Tumor Cells (CTCs)and Correlative Analysis of Telomerase Activity [ Time Frame: Prior to screening, prior to first loading dose, and prior to cycles 1, 2, 3 and 5 ] [ Designated as safety issue: No ]
    To evaluate the effect of therapy with docetaxel and OGX-427 on peripheral blood circulating tumor cells (CTCs) enumeration and expression of Hsp27 and other relevant proteins via immunoflourescence, and levels of telomerase by quantitative polymerase chain reaction (PCR), and explore their relation with clinical outcomes.


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Arm: Arm A
Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle.
Drug: OGX-427

Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.

Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Participants without documented disease progression who have discontinued from study treatment not due to toxicity related to OGX-427 can also continue to receive OGX-427 maintenance as long as they have completed disease assessments following at least 2 cycles of chemotherapy. Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity.

Drug: Docetaxel

For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.

For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.

Active Comparator: Control Arm: Arm B
Docetaxel (75 mg/M2) will be administered IV on day 1 of each 21 day cycle for a maximum of 10 cycles.
Drug: Docetaxel

For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.

For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histologically documented metastatic or locally inoperable advanced urothelial carcinoma (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3, or M1 disease. NOTE: Aberrant differentiation such as squamous, glandular (adenocarcinoma), and micropapillary are eligible unless the tumor is considered a pure histological variant according to the pathology report. Participants with small cell histology are not eligible.
  • Participants must have 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 RECIST v1.1 criteria.
  • Participants must have received prior systemic chemotherapy treatment for metastatic urothelial carcinoma. NOTE: Up to 2 prior systemic chemotherapeutic regimens given in the metastatic disease setting for urothelial carcinoma are allowed.
  • Specifically, subjects must meet one or more of the following criteria:

    1. Progression during or after treatment with a regimen that includes a platinum salt (e.g., carboplatin or cisplatin) OR
    2. Disease recurrence within one year after neoadjuvant or adjuvant platinum-based systemic chemotherapy, measured from the date of last dose of chemotherapy or surgery until the day the informed consent is signed
  • Participants must be ≥18 years since no dosing or adverse event data are currently available on the use of OGX-427 in participants <18 years of age.
  • Minimum of 21 days have elapsed since prior major surgery, with recovery from any adverse events.
  • Minimum of 14 days have elapsed since any prior radiation therapy, with recovery from any adverse events.
  • The effects of OGX-427 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • History of treatment with docetaxel in any setting. Participants treated with prior paclitaxel are eligible.
  • Prior enrollment in the OncoGenex Phase 2 Study OGX-427-02.
  • Participants may not be receiving other investigational agents.
  • Participants with known brain or spinal cord metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of central nervous system (CNS) disease.
  • History of allergic reactions or severe hypersensitivity reactions to drugs formulated with polysorbate 80 or antisense oligonucleotides.
  • Peripheral neuropathy ≥Grade 2.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • Cerebrovascular accident or pulmonary embolus within 3 months of randomization.
  • Pregnant women and breast feeding women are excluded from this study because of the risk to a fetus due to docetaxel chemotherapy and OGX-427 systemic treatment (fertility toxicology studies have not been completed for OGX-427).
  • Active second malignancy (except non-melanomatous skin cancer or incidental prostate cancer found on cystectomy): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780545

Contacts
Contact: Costantine Albany, M.D. 3179212050 gegould@iupui.edu
Contact: Cynthia Burkhardt, R.N. 3179212050 gegould@iupui.edu

  Show 34 Study Locations
Sponsors and Collaborators
Hoosier Cancer Research Network
OncoGenex Technologies
Investigators
Study Chair: Noah Hahn, M.D. Hoosier Cancer Research Network
  More Information

Additional Information:
No publications provided

Responsible Party: Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01780545     History of Changes
Other Study ID Numbers: GU12-160
Study First Received: January 25, 2013
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoosier Cancer Research Network:
OGX-427
Docetaxel

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014