AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

NCT00513071 | Completed Phase 2 Results

• 5 other identifiers: NCI-2012-02842PHII-79N01CM62209N01CM62201CDR0000559142
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Conditions

Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA Response Rate

  Complete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR

  PSA measured every 4 weeks

Secondary Outcomes (6)

• Progression-free Survival (PFS)

  From start of treatment until progression or death, up to 2 years

• Time to Treatment Failure

  From first day of treatment until discontinuation of treatment, up to 2 years

• Overall Survival

  From start of treatment, up to 5 years

• Toxicity Data

  Up to 2 years

• Relationship Between Changes in Laboratory Correlates and Response and Survival

  Up to 2 years

Study Arms (1)

Treatment (saracatinib)

EXPERIMENTAL

Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Drug: saracatinib; Other: laboratory biomarker analysis

Interventions

saracatinib DRUG

Given orally

Also known as: AZD0530

Treatment (saracatinib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (saracatinib)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable and meeting 1 of the following criteria:
• No prior chemotherapy and relatively minimal cancer spread
• Only one prior taxane-based chemotherapy for aggressive and/or symptomatic disease
• Must have prostate cancer considered to be hormone refractory or androgen independent by one or more of the following criteria (despite androgen deprivation and anti-androgen withdrawal when applicable):
• Progression of unidimensionally measurable disease assessed within 28 days prior to initial administration of drug
• Progression of evaluable but not measurable disease assessed within 28 days prior to initial administration of drug for PSA evaluation and within 42 days for imaging studies (e.g., bone scans)
• Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and non-target lesions (e.g., PSA level) assessed within 28 days prior to initial administration of drug
• Measurable disease is not required but is allowed
• Must be surgically or medically castrated
• If the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists
• Serum testosterone must be at castrate levels (\< 50 ng/dL) at least 3 months prior to registration
• ECOG performance status 0-2
• WBC \>= 3,000/uL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 100,000/uL

You may not qualify if:

• Known brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
• Patients with any of the following conditions that impair the ability to swallow AZD0530 tablets
• Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation
• Prior surgical procedures affecting absorption
• Active peptic ulcer disease
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
• Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Use of specifically prohibited CYP3A4-active agents or substances
• Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
• Patients receiving any other investigational agents
• No investigational or commercial agents or therapies other than study drugs may be administered with the intent to treat the patient's malignancy
• HIV-positive patients on combination antiretroviral therapy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

saracatinib

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Primo Lara

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 19, 2018
• Results First Posted: October 3, 2014

Record last verified: 2018-03

Locations

US (1)