Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)
NCT ID: NCT01171898
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
127 participants
INTERVENTIONAL
2010-07-26
2025-07-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Post-abiraterone metastatic CRPC (Phase 2)
Participants with metastatic CRPC that are chemotherapy-naive, but have been previously treated with abiraterone will be enrolled. ARN-509 will be administered at MTD and/or RP2D, determined in Phase 1.
ARN-509 (Phase 2)
ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.
Dose Escalation Cohort (Phase 1)
ARN-509 will be administered at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily. Once Recommended Phase 2 Dose (RP2D) has been selected, Phase 1 participants being treated at the lower dose levels will be allowed to escalate to the RP2D level at the discretion of the primary investigator.
ARN-509 (Phase 1)
ARN-509 will be administered at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily.
Non-metastatic CRPC (Phase 2)
Participants with non-metastatic, treatment-naive Castration-Resistant Prostate Cancer (CRPC) with rapidly rising Prostate Specific Antigen (PSA) will be enrolled. ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.
ARN-509 (Phase 2)
ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.
Treatment-naive metastatic CRPC (Phase 2)
Participants with treatment-naive metastatic CRPC will be enrolled. ARN-509 will be administered at MTD and/or RP2D, determined in Phase 1.
ARN-509 (Phase 2)
ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.
Interventions
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ARN-509 (Phase 1)
ARN-509 will be administered at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily.
ARN-509 (Phase 2)
ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.
Eligibility Criteria
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Inclusion Criteria
2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
5. A life expectancy of at least 3 months
1. Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression
2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
5. A life expectancy of at least 3 months
1. Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression
2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
5. A life expectancy of at least 3 months
6. Patients must have received a minimum of 6 months of abiraterone treatment prior to disease progression
Exclusion Criteria
2. Prior treatment with MDV3100
3. Prior treatment with abiraterone
4. Prior treatment with ketoconazole
5. Concurrent treatment with medications known to have seizure potential
6. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible.
7. QTc \> 450 msec
8. History of seizure or condition that may predispose to seizure
9. Evidence of severe or uncontrolled systemic disease or HIV infection
METASTATIC CRPC, TREATMENT-NAIVE
1. History of, or current metastases in the brain or untreated spinal cord compression
2. Prior treatment with MDV3100
3. Prior treatment with abiraterone
4. Prior treatment with ketoconazole
5. Concurrent treatment with medications known to have seizure potential
6. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible.
7. QTc \> 450 msec
8. History of seizure or condition that may predispose to seizure
9. Evidence of severe or uncontrolled systemic disease or HIV infection
METASTATIC CRPC, CHEMOTHERAPY-NAIVE, POST-ABIRATERONE
1. History of, or current metastases in the brain or untreated spinal cord compression
2. Prior treatment with MDV3100
3. Prior treatment with ketoconazole
4. Concurrent treatment with medications known to have seizure potential
5. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible.
6. QTc \> 450 msec
7. History of seizure or condition that may predispose to seizure
8. Evidence of severe or uncontrolled systemic disease or HIV infection
18 Years
MALE
No
Sponsors
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Aragon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Aragon Pharmaceuticals, Inc Clinical Trial
Role: STUDY_DIRECTOR
Aragon Pharmaceuticals, Inc.
Locations
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San Diego, California, United States
San Francisco, California, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Omaha, Nebraska, United States
New York, New York, United States
Raleigh, North Carolina, United States
Portland, Oregon, United States
Lancaster, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Dallas, Texas, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Countries
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References
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Rathkopf DE, Smith MR, Ryan CJ, Berry WR, Shore ND, Liu G, Higano CS, Alumkal JJ, Hauke R, Tutrone RF, Saleh M, Chow Maneval E, Thomas S, Ricci DS, Yu MK, de Boer CJ, Trinh A, Kheoh T, Bandekar R, Scher HI, Antonarakis ES. Androgen receptor mutations in patients with castration-resistant prostate cancer treated with apalutamide. Ann Oncol. 2017 Sep 1;28(9):2264-2271. doi: 10.1093/annonc/mdx283.
Smith MR, Antonarakis ES, Ryan CJ, Berry WR, Shore ND, Liu G, Alumkal JJ, Higano CS, Chow Maneval E, Bandekar R, de Boer CJ, Yu MK, Rathkopf DE. Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509), a Potent Androgen Receptor Antagonist, in the High-risk Nonmetastatic Castration-resistant Prostate Cancer Cohort. Eur Urol. 2016 Dec;70(6):963-970. doi: 10.1016/j.eururo.2016.04.023. Epub 2016 May 6.
Other Identifiers
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ARN-509-001
Identifier Type: OTHER
Identifier Source: secondary_id
CR103304
Identifier Type: -
Identifier Source: org_study_id