Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

NCT01685125 | Unknown Phase 2 DMC

• 2 other identifiers: 4P-12-1NCI-2012-01485
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well giving abiraterone acetate and prednisone with or without dasatinib works in treating patients with metastatic, hormone-resistant prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of androgens made by the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether abiraterone acetate and prednisone is more effective than abiraterone acetate, prednisone, and dasatinib in treating prostate cancer

Conditions

Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A one-sided, 0.05-level log rank test will be used to compare the two arms in terms of PFS. PFS will be estimated using the product-limit method of Kaplan and Meier.

  From the start of abiraterone acetate until first evidence of disease progression or until death from any cause, whichever occurs first, assessed up to 3 years

Secondary Outcomes (4)

• Overall response

  Up to 3 years

• PSA change response according to PSA Working Group Criteria 2

  Baseline and 12 weeks

• Overall survival

  From start of abiraterone acetate and/or dasatinib treatment until death due to any cause or time the patient was last known to be alive, assessed up to 3 years

• Intent-to-treat analysis

  Up to 3 years

Study Arms (2)

Arm A (abiraterone acetate, prednisone)

ACTIVE COMPARATOR

Abiraterone acetate 1000 mg PO QD and Prednisone 5 mg PO BID on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: abiraterone acetate; Drug: prednisone

Arm B (abiraterone acetate, prednisone, dasatinib)

EXPERIMENTAL

Abiraterone acetate 1000 mg PO QD, Prednisone 5 mg PO BID, and dasatinib 100 mg PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: abiraterone acetate; Drug: dasatinib; Drug: prednisone

Interventions

abiraterone acetate DRUG

Given PO

Also known as: CB7630, Zytiga

Arm A (abiraterone acetate, prednisone); Arm B (abiraterone acetate, prednisone, dasatinib)

dasatinib DRUG

Given PO

Also known as: BMS-354825, Sprycel

Arm B (abiraterone acetate, prednisone, dasatinib)

prednisone DRUG

Given PO

Also known as: DeCortin, Deltra

Arm A (abiraterone acetate, prednisone); Arm B (abiraterone acetate, prednisone, dasatinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic, castration-resistant prostate cancer
• Defined as evaluable radiographic disease with rising PSA x 2 (at least 1 week apart) or radiographic progression (new soft tissue/bone lesions or enlarging soft tissue lesions) despite medical or surgical castration
• No limit on prior hormonal therapies (i.e. anti-androgens, ketoconazole) except that subject must not have received abiraterone previously
• No limit on prior biologic therapies (i.e. immune therapy, antiangiogenic, targeted) except that patient should not have received dasatinib or other v-src sarcoma (Schmidt-Ruppin A-2) viral oncogene homolog (avian) (src)-targeted therapy
• No prior chemotherapy for metastatic disease
• \* Subjects who have received chemotherapy in the neoadjuvant or adjuvant setting will be eligible provided chemotherapy was completed \> 6 months prior to enrollment
• Eastern Cooperative Oncology Group (ECOG) 0-2
• Total bilirubin =\< 1.5 times the institutional upper limit of normal (ULN) except for Gilbert's syndrome
• Hepatic enzymes (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] ) =\< 2.5 times the institutional ULN
• Serum sodium (Na), potassium (K+), magnesium (Mg+), phosphate and calcium (Ca+) \> lower limit of normal (LLN)
• Serum creatinine =\< 1.5 time the institutional ULN
• Hemoglobin (Hb) \>= 9
• Platelets \>= 100,000
• Absolute neutrophil count (ANC) \>= 1000
• Ability to take oral medication (study medications must be swallowed whole)

You may not qualify if:

• Known hepatitis B or C or human immunodeficiency virus (HIV), regardless of viral load
• Radiation for palliation of bony metastases within the preceding 2 weeks
• Prior chemotherapy for metastatic castration-resistant prostate cancer (CRPC)
• \* Immune therapy with sipuleucel-T is allowed, provided the last infusion was \>= 28 days prior to study therapy and there has been at least one documented PSA value rising after completion of sipuleucel-T therapy or progression of disease on imaging after sipuleucel-T
• Malignancy (aside from prostate cancer) which required radiotherapy or systemic treatment within the past 5 years
• Concurrent medical condition which may increase the risk of toxicity, including:
• Pleural or pericardial effusion of any grade at the time of study entry
• Diagnosed congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) \*\* Prolonged QTc/f interval on pre-entry electrocardiogram (\> 450 msec)
• Hypokalemia or hypomagnesemia if it cannot be corrected prior to abiraterone administration
• History of significant bleeding disorder unrelated to cancer, including:
• Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
• Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
• Ongoing or recent (=\< 3 months) significant gastrointestinal bleeding
• Prohibited treatments and/or therapies

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; Dasatinib; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pregnadienediols; Pregnadienes; Pregnanes

Study Officials

• Tanya Dorff

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2018
• Last Updated: July 7, 2017

Record last verified: 2017-06

Locations

US (1)