Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:August 2012
End Date:December 2016

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A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)

This Phase 3 study has been designed to confirm that adding custirsen to
cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes
compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate
resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter,
international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs.
cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal
probability to the two arms.

Until recently, options for second-line chemotherapy in CRPC have included docetaxel
retreatment, mitoxantrone, or other chemotherapies, without proven clinical benefit. In
2010, a Phase 3 second-line chemotherapy trial (TROPIC) showed a survival advantage for
cabazitaxel, a semi-synthetic taxane selected to overcome the emergence of taxane
resistance, when compared to mitoxantrone.

Clusterin is a stress-activated cytoprotective chaperone up-regulated by a variety of
anti-cancer therapies that confers treatment resistance when over-expressed. Inhibition of
clusterin expression using custirsen has been shown to enhance tumor cell death following
treatment with chemotherapy.

The clinical activity of custirsen in combination with the taxane docetaxel has been shown
in two Phase 2 studies. Given the results observed using a taxane as either first-line or
second-line chemotherapy in CRPC, combination with custirsen may decrease taxane resistance
and enhance the survival benefit of taxane therapy. Thus, a combination of custirsen with
cabazitaxel may further enhance survival in second-line taxane chemotherapy for CRPC.

Inclusion Criteria:

- Histological or cytological diagnosis of adenocarcinoma of the prostate

- Metastatic disease on chest, abdominal, or pelvic CT scan and/or bone scan

- Previous first-line treatment for CRPC with a docetaxel-containing regimen

- Current progressive disease

- Increasing serum PSA level (for patients who progress based only on increasing serum
PSA level, a minimum starting value of 5.0 ng/mL is required)

- Baseline laboratory values as defined

- Willing to continue primary androgen suppression with gonadotropin-releasing hormone
(GnRH) analogues (unless treated with bilateral orchiectomy)

- Karnofsky score ≥70%

- At least 21 days have passed since completing radiotherapy

- At least 21 days have passed since receiving any investigational agent at the time of
randomization

- At least 21 days have passed since major surgery

- Recovered from any docetaxel therapy-related neuropathy to ≤grade 1 at the time of
randomization

- Recovered from all therapy related toxicity to ≤grade 2 (except alopecia, anemia, and
any signs or symptoms of androgen deprivation therapy) at the time of randomization

- Able to tolerate a starting dose of 25 mg/m² cabazitaxel

- Willing to not add, delete, or change current bisphosphonate or denosumab usage

- Able to tolerate oral prednisone at 10 mg per day

- Competent to provide written informed consent

Exclusion Criteria:

- Received any other cytotoxic chemotherapy beyond the first-line docetaxel-containing
regimen as treatment for prostate cancer

- Received prior radioisotope with strontium 89 or samarium 153

- Received any cycling, intermittent, or continuous hormonal treatment within 21 days
prior to randomization with the exception of the continuous GnRH analogues (prior
treatment with abiraterone or MDV3100 is allowed as long as 21 days have passed since
last dose)

- Participated in a prior Phase 3 clinical study evaluating custirsen regardless of
study arm assignment

- Requiring ongoing treatment during the study with medications known to be either
strong CYP3A inhibitors or strong CYP3A inducers

- History of or current documented brain metastasis or carcinomatous meningitis,
treated or untreated

- Current symptomatic cord compression requiring surgery or radiation therapy

- Active second malignancy (except non melanomatous skin or superficial bladder cancer)
defined in general as requiring anticancer therapy or at high risk of recurrence
during the study

- Uncontrolled medical condition or significant concurrent illness that in the opinion
of the Investigator would preclude protocol therapy

- Known severe hypersensitivity to taxanes or polysorbate 80-containing drugs

- Planned concomitant participation in another clinical trial of an experimental agent,
vaccine, or device
We found this trial at
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Salt Lake City, Utah 84106
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Boca Raton, Florida 33486
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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1 Boston Medical Center Place
Boston, Massachusetts 02118
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Boulder, Colorado
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Charlotte, North Carolina 28204
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Chattanooga, Tennessee 37404
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
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The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Dallas, Texas 75246
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Detroit, Michigan 48201
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Greenville, South Carolina 29605
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80 Seymour St
Hartford, Connecticut 6102
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Inverness, Florida
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450 Lakeville Rd
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Marietta, Georgia 30060
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Marina Del Rey, California 90292
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100 N Humphreys Blvd
Memphis, Tennessee 38120
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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5900 Lake Wright Dr
Norfolk, Virginia 23502
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Richmond, Virginia 23235
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2315 Stockton Blvd.
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San Diego, California 92123
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750 East Adams Street
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818 N. Emporia, #403
Wichita, Kansas 67214
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