Castrate-Resistant Prostate CancerPhase 3NCT01083615
A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
A Phase 3 study testing custirsen sodium, isotonic, 0.9% sodium chloride and docetaxel in people with Castrate-Resistant Prostate Cancer and Hormone Refractory Prostate Cancer, run by Achieve Life Sciences at 33 sites in 5 countries.
Trial summary
The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Castrate-Resistant Prostate Cancer, Hormone Refractory Prostate Cancer
- What is being tested?
- custirsen sodium, isotonic, 0.9% sodium chloride and docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 33 sitesin 5 countries
- Study dates
- Mar 2010to Mar 2013
- 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 to 99 years
- 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 at screening on a chest, abdomen or pelvic CT or bone scan.
- Concurrent pain and analgesic use that is viewed by the Investigator to be related to prostate cancer.
- Received at least 4 cycles of prior docetaxel-based first-line chemotherapy for metastatic disease based on a q3 week schedule of docetaxel. Patients treated on a weekly or alternate schedule for first-line docetaxel must have received an accumulated dose of docetaxel of at least 300 mg/M2.
- Current progressive disease during or after completing first-line docetaxel treatment.
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- Baseline laboratory values at screening visit within protocol defined limits.
- Must be willing to continue primary androgen suppression with luteinizing hormone releasing hormone (LHRH) analogues throughout the study, if not treated with bilateral orchiectomy.
- Adequate bone marrow function.
- Karnofsky score ≥ 70% at screening visit.
- At least 21 days have passed since completing radiotherapy at the time of randomization.
- At least 21 days have passed since completing any cytotoxic agent or investigational agent given in combination with the docetaxel-based first-line therapy, including ASOs (except custirsen which is an exclusion criterion), at the time of randomization.
- Has recovered from all therapy related toxicity to ≤ grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy).
- Patient can tolerate a starting dose of docetaxel of 75 mg/M2 or cabazitaxel at 25 mg/M2.
- Patient must have remained on the same bisphosphonate or denosumab usage for a minimum of 12 weeks prior to randomization.
- Written informed consent must be obtained prior to any protocol-specific procedures being performed.
Who cannot join
- More than two interruptions in first-line docetaxel therapy. An interruption will be defined as more than 6 weeks between doses.
- Life expectancy less than 12 weeks.
- Previously participated in any clinical trial evaluating custirsen.
- Received any other cytotoxic chemotherapy as a second-line treatment after first-line docetaxel-based therapy.
- Not on any opioid analgesic regimen for their prostate cancer-related pain.
- Receiving more than one drug within each of the separate categories of long-acting opioid, short-acting opioid, and non-opioid.
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- Receiving any analgesic specified in the protocol as unacceptable for this study.
- Planned concomitant participation in another clinical trial of an experimental agent, vaccine or device. Concomitant participation in observational studies is acceptable.
- Inability to communicate and read in English, Spanish or French.
Trial locations and contacts
33 sites in 5 countries.
33 sites in 5 countries
United States20 sites
Study site
Baltimore, Maryland, 21201
Study site
Burlington, Massachusetts, 01805
Study site
Canton, Ohio, 44718
Study site
Columbia, South Carolina, 29209
Study site
Detroit, Michigan, 48201
Study site
Fort Lauderdale, Florida, 33308
Study site
Honolulu, Hawaii, 96813
Study site
Kansas City, Missouri, 64132
Study site
La Verne, California, 91705
Study site
Las Vegas, Nevada, 89169
Study site
Memphis, Tennessee, 38120
Study site
Metairie, Louisiana, 70006
Study site
Oklahoma City, Oklahoma, 73120
Study site
Omaha, Nebraska, 68130
Study site
Portland, Oregon, 97239
Study site
Raleigh, North Carolina, 27607
Study site
Syracuse, New York, 13210
Study site
Tampa, Florida, 33612
Study site
Tyler, Texas, 75701
Study site
Urbana, Illinois, 61801
Spain5 sites
Study site
Barcelona
Study site
Madrid
Study site
Pamplona
Study site
Sabadell
Study site
Valencia
France4 sites
Study site
Lyon
Study site
Paris
Study site
Saint-Herblain
Study site
Villejuif
Canada2 sites
Study site
Hamilton, Ontario, L8V 5C2
Study site
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Pain Palliation Benefit of Adding Custirsen to a Taxane for Second-Line Chemotherapy in Men With Castrate Resistance Prostate Cancer
The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multicenter, international trial enrolling patients with metastatic CRPC who had a response to first-line docetaxel therapy and have prostate cancer-related pain with progression of disease. The intended intervention is second-line treatment with docetaxel retreatment or cabazitaxel plus study agent, where custirsen is to be administered in the investigational arm and placebo is to be administered in the control arm.
Selection of the chemotherapy (docetaxel re-treatment or cabazitaxel) is to be determined by the treating physician, based on the patient's first-line response.
The study will primarily assess pain and analgesic use for evaluation of durable pain palliation in response to study treatment. Pain and analgesic use will be obtained via a 3rd party contact center (direct contact with patient).
Study treatment starts with a Loading Dose Period during which three infusions of study agent (custirsen vs. placebo) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel or cabazitaxel on a 21-day cycle with weekly study agent (custirsen vs. placebo) infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Patients will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol. If study treatment is completed or discontinued prior to pain progression, 6-day assessments will continue every 3 weeks until pain progression is documented. Follow-up after study treatment will occur for safety parameters for 3 weeks after the last study agent infusion in all patients. Survival status updates are to be reported every 12 weeks following documentation of pain progression. The amount of time that patients remain on the study will vary; but the average survival of these patients who receive second line taxane treatment is expected to be 14 to 15 months.
- Being tested
- custirsen sodium, isotonic, 0.9% sodium chloride, docetaxel, cabazitaxel, prednisone
- Keywords
- CRPC patients with cancer related pain, CRPC, HRPC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custirsen sodiumDrug
Also called OGX-011
An antisense oligonucleotide that blocks production of clusterin
isotonic, 0.9% sodium chlorideDrug
Placebo for custirsen sodium
docetaxelDrug
cabazitaxelDrug
prednisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Custirsen | Experimental | Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of custirsen will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly custirsen infusions (640 mg total dose) on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol. Receives: Drug: custirsen sodium; Drug: docetaxel; Drug: cabazitaxel; Drug: prednisone |
| Placebo | Placebo comparator | Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of placebo (isotonic, 0.9% sodium chloride) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly placebo infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol. Receives: Drug: isotonic, 0.9% sodium chloride; Drug: docetaxel; Drug: cabazitaxel; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To ascertain whether the investigational arm has a greater proportion of patients with durable pain palliation as compared to the control arm.
Measured: 3 to 6 months
Secondary outcomes (2)
To ascertain whether patients randomized to the investigational arm have a longer time to pain progression as compared to patients randomized to the control arm.
Measured: 6 months.
Safety
Comparison of treatment arms with respect to the incidence of serious adverse events and the incidence of grade 3 or higher adverse events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Unable to enroll due to criteria for stable baseline pain
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castrate-Resistant Prostate CancerStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Tomasz M Beer, M.D., Principal investigator, Oregon Health and Science UniversitySebastien J Hotte, M.D., Principal investigator, Juravinski Cancer Centre, McMaster UniversityKarim Fizazi, M.D., Ph.D., Principal investigator, Institut Gustave Roussy, University of Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083615
- Sponsor's protocol ID
- OGX-011-10
- Status last verified
- Oct 2016
- First submitted
- 26 Feb 2010
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Pain Palliation Benefit of Adding Custirsen to a Taxane for Second-Line Chemotherapy in Men With Castrate Resistance Prostate Cancer
- ClinicalTrials.gov ID
- NCT01083615
- Acronym / sponsor ID
- OGX-011-10
- Keywords
- CRPC patients with cancer related pain, CRPC, HRPC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll due to criteria for stable baseline pain
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.
Detailed description
This is a randomized, double-blind, placebo-controlled, multicenter, international trial enrolling patients with metastatic CRPC who had a response to first-line docetaxel therapy and have prostate cancer-related pain with progression of disease. The intended intervention is second-line treatment with docetaxel retreatment or cabazitaxel plus study agent, where custirsen is to be administered in the investigational arm and placebo is to be administered in the control arm.
Selection of the chemotherapy (docetaxel re-treatment or cabazitaxel) is to be determined by the treating physician, based on the patient's first-line response.
The study will primarily assess pain and analgesic use for evaluation of durable pain palliation in response to study treatment. Pain and analgesic use will be obtained via a 3rd party contact center (direct contact with patient).
Study treatment starts with a Loading Dose Period during which three infusions of study agent (custirsen vs. placebo) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel or cabazitaxel on a 21-day cycle with weekly study agent (custirsen vs. placebo) infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID.
Patients will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol. If study treatment is completed or discontinued prior to pain progression, 6-day assessments will continue every 3 weeks until pain progression is documented. Follow-up after study treatment will occur for safety parameters for 3 weeks after the last study agent infusion in all patients. Survival status updates are to be reported every 12 weeks following documentation of pain progression. The amount of time that patients remain on the study will vary; but the average survival of these patients who receive second line taxane treatment is expected to be 14 to 15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custirsen | Experimental | Drug: custirsen sodium, Drug: docetaxel, Drug: cabazitaxel, Drug: prednisoneStudy treatment starts with a Loading Dose Period (1 week) during which 3 infusions of custirsen will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly custirsen infusions (640 mg total dose) on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID. Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol. |
| Placebo | Placebo comparator | Drug: isotonic, 0.9% sodium chloride, Drug: docetaxel, Drug: cabazitaxel, Drug: prednisoneStudy treatment starts with a Loading Dose Period (1 week) during which 3 infusions of placebo (isotonic, 0.9% sodium chloride) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly placebo infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID. Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years on the date of consent.
- Histological or cytological diagnosis of adenocarcinoma of the prostate.
- Metastatic disease at screening on a chest, abdomen or pelvic CT or bone scan.
- Concurrent pain and analgesic use that is viewed by the Investigator to be related to prostate cancer.
- Received at least 4 cycles of prior docetaxel-based first-line chemotherapy for metastatic disease based on a q3 week schedule of docetaxel. Patients treated on a weekly or alternate schedule for first-line docetaxel must have received an accumulated dose of docetaxel of at least 300 mg/M2.
Key exclusion criteria (9 listed)
- More than two interruptions in first-line docetaxel therapy. An interruption will be defined as more than 6 weeks between doses.
- Life expectancy less than 12 weeks.
- Previously participated in any clinical trial evaluating custirsen.
- Received any other cytotoxic chemotherapy as a second-line treatment after first-line docetaxel-based therapy.
- Not on any opioid analgesic regimen for their prostate cancer-related pain.
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 |
|---|---|---|
| custirsen sodiumAlso: OGX-011An antisense oligonucleotide that blocks production of clusterin | Drug | Custirsen |
| isotonic, 0.9% sodium chloridePlacebo for custirsen sodium | Drug | Placebo |
| docetaxel | Drug | Custirsen, Placebo |
| cabazitaxel | Drug | Custirsen, Placebo |
| prednisone | Drug | Custirsen, Placebo |
Primary outcome
To ascertain whether the investigational arm has a greater proportion of patients with durable pain palliation as compared to the control arm.
Time frame: 3 to 6 months
2 secondary outcomes
To ascertain whether patients randomized to the investigational arm have a longer time to pain progression as compared to patients randomized to the control arm.
Time frame: 6 months.
Safety
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Unable to enroll due to criteria for stable baseline pain). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
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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.
Tomasz M Beer, M.D. principal investigator
Oregon Health and Science University
Sebastien J Hotte, M.D. principal investigator
Juravinski Cancer Centre, McMaster University
Karim Fizazi, M.D., Ph.D. principal investigator
Institut Gustave Roussy, University of Paris
33 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing custirsen sodium, isotonic, 0.9% sodium chloride and docetaxel in people with Castrate-Resistant Prostate Cancer and Hormone Refractory Prostate Cancer, run by Achieve Life Sciences at 33 sites in 5 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 9 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: stopped early, as of the sponsor's last update on 12 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 33 sites in United States, Spain, France, Canada, United Kingdom. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Unable to enroll due to criteria for stable baseline pain). Results are not available in the source record.
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?
To ascertain whether the investigational arm has a greater proportion of patients with durable pain palliation as compared to the control arm. (time frame: 3 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2016.