Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer

NCT01200810 | Terminated Phase 2 Results

• 3 other identifiers: NCI-2011-02527CINJ-081001CDR0000684276
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This partially randomized phase II trial is studying how well giving bicalutamide together with RO4929097 works in treating patients with previously treated prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bicalutamide together with RO4929097 may be an effective treatment for prostate cancer

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Time to PSA Progression

  Time to PSA progression will be compared in the two groups using a log-rank test for a maximum of 54 weeks.

  Up to 12 months

Secondary Outcomes (7)

• Proportion of Patients Who Achieve Complete Response (by PSA) During the Combination Phase

  Up to 12 months

• Proportion of Patients With PSA Progression During the Combination Phase

  Up to 12 months

• Time to PSA Nadir During the Combination Phase

  Up to 12 months

• Time to PSA Progression During the Combination Phase

  Up to 12 months

• Time to PSA Progression During the Observation Phase

  Up to 12 months

Study Arms (2)

Arm I

PLACEBO COMPARATOR

Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression. COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.

Other: placebo; Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Drug: bicalutamide

Arm II

EXPERIMENTAL

Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression. COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.

Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Drug: bicalutamide

Interventions

placebo OTHER

Given orally

Also known as: PLCB

Arm I

gamma-secretase/Notch signalling pathway inhibitor RO4929097 DRUG

Given orally

Also known as: R4733, RO4929097

Arm I; Arm II

bicalutamide DRUG

Given orally

Also known as: Casodex, CDX

Arm I; Arm II

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed prostate cancer
• Stage D0 OR D1 disease (i.e., tumor originally diagnosed as being limited to the prostate and regional lymph nodes)
• Has a rising PSA value after definitive local therapy (i.e., prostatectomy or radiotherapy) and no radiographic evidence of disease
• PSA progression after local treatment:
• PSA values for patients after surgery must be ≥ 0.2 ng/mL, determined by two measurements, ≥ 1 month apart and ≥ 6 months after prostatectomy
• PSA values for patients after radiotherapy must be ≥ 2.0 ng/mL above the nadir PSA achieved after radiotherapy, determined by two measurements at 1 month apart and ≥ 6 months after completion of the radiotherapy treatment (patients who received adjuvant or salvage radiotherapy after prostatectomy must have PSA of ≥ 0.2 ng/mL)
• The first two PSA values, along with a third (study baseline) value must all be rising (i.e., there must be an overall rising trajectory, such that the third value cannot be lower than the first value)
• No metastatic disease on baseline bone scan and CT scan of the abdomen/pelvis
• ECOG performance status 0-2
• Life expectancy ≥ 6 months
• WBC ≥ 3,000/mm\^3
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 40 mL/min for patients with creatinine levels above normal

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2,2-dimethyl-N-(6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-N'-(2,2,3,3,3-pentafluoropropyl)malonamide; bicalutamide

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Mark Stein, MD
• Organization: Rutgers Cancer Institute of New Jersey

steinmn@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu

(732) 235-8675

Study Officials

• Mark Stein

  UMDNJ - Robert Wood Johnson University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 14, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 2, 2017
• Results First Posted: October 23, 2014

Record last verified: 2017-10

Locations

US (1)