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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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)


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) / Recommended Phase 2 dosage (RP2D)

Outcome Description:

To determine the Maximum Tolerated Dosage (MTD)/ Recommended Phase 2 dosage (RP2D) of ARN-509 when administered in combination with abiraterone acetate.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Edna Chow Maneval, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Aragon Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ARN-509-004

NCT ID:

NCT01792687

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Metastatic castrate resistant prostate cancer (CRPC)
  • Prostatic Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115