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Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01792687
First received: February 12, 2013
Last updated: May 26, 2017
Last verified: May 2017
February 12, 2013
May 26, 2017
February 5, 2013
May 10, 2014   (Final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) / Recommended Phase 2 dosage (RP2D) [ Time Frame: 12 months ]
To determine the Maximum Tolerated Dosage (MTD)/ Recommended Phase 2 dosage (RP2D) of ARN-509 when administered in combination with abiraterone acetate.
Same as current
Complete list of historical versions of study NCT01792687 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics [ Time Frame: 12 months ]
    To characterize the pharmacokinetics (PK) of abiraterone at steady-state prior to ARN-509 administration, and both abiraterone and ARN-509 at steady-state following combined dosing of both agents.
  • Anti-tumor activity [ Time Frame: 12 months ]
    To perform preliminary assessment of the anti-tumor activity of ARN 509 in combination with abiraterone acetate by evaluation of radiographic tumor response by modified RECIST criteria.
  • PSA Response [ Time Frame: 12 months ]
    To assess the magnitude and duration of PSA response in patients receiving ARN 509 plus abiraterone acetate.
  • Treatment Response/Resistance [ Time Frame: 12 months ]
    To analyze potential mechanisms of response and resistance to treatment with ARN-509 plus abiraterone acetate in tissue obtained from serial biopsies of CRPC.
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate
Phase Ib, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN-509 in Combination With Abiraterone Acetate in Patients With Metastatic Castrate Resistant Prostate Cancer (CRPC)
This is a Phase Ib, open label study of ARN-509 administered in combination with abiraterone acetate and prednisone in patients with metastatic castration-resistant prostate cancer.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Prostate Cancer
  • Drug: ARN-509
    Dose-escalation: 120 milligram (mg), 180 mg, 240 mg, oral, daily
  • Drug: Abiraterone acetate
    1,000 mg, oral, daily
  • Drug: Prednisone
    5 mg, oral, daily
Experimental: Treatment
ARN-509 when combined with the approved dose of abiraterone acetate (1,000 mg daily) plus prednisone (5 mg daily).
Interventions:
  • Drug: ARN-509
  • Drug: Abiraterone acetate
  • Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6
December 12, 2017
May 10, 2014   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Participants must have histologically confirmed prostate cancer.
  • Radiographic evidence of metastatic disease, detectable by bone scan, CT scan, or MRI. At least one site of metastatic disease must be amenable to needle biopsy.
  • Castrate levels of testosterone (testosterone < 50 ng/dL) on androgen deprivation therapy (ADT). Patients who have not undergone orchiectomy will continue gonadotropin releasing hormone (GnRH) agonist or antagonist therapy.
  • Age > 18 years
  • ECOG performance status < 2
  • Evidence of disease progression on ADT. Patients must have two serial rises in PSA from nadir, with at least 1 week between PSA measurements, with a minimum PSA of 2 ng/mL, OR patients must have radiographic evidence of progression. Nadir is defined as the lowest PSA value after beginning the most recent therapy for metastatic CRPC.

Key Exclusion Criteria:

  • Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Participants may not be receiving any other study agents.
  • Participants with known brain metastases
  • Any history of seizure or a condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy).
  • Concurrent therapy with medications known to have seizure potential (those must have been discontinued or substituted for at least 28 days prior to starting the trial)
  • Concurrent treatment with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice) or inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort)
  • History of pituitary dysfunction
  • History of adrenal dysfunction
  • Requirement for steroid use greater than 10 mg of prednisone daily
  • History of gastrointestinal disorder or prior extensive gastrointestinal surgery that may interfere with sufficient absorption of the study compounds.
  • Prior history of CYP17 inhibitors (e.g., abiraterone acetate, TAK-700) and second-generation anti-androgen (e.g., MDV3100)
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01792687
CR103306
12-338 ( Other Identifier: Dana Farber / Harvard Cancer Center )
ARN-509-004
No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Aragon Pharmaceuticals, Inc.
Aragon Pharmaceuticals, Inc.
Not Provided
Study Director: Aragon Pharmaceuticals, Inc Clinical Trial Aragon Pharmaceuticals, Inc.
Aragon Pharmaceuticals, Inc.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP