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Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy (SUN 1120)

This study has been terminated.
(Study A6181120 was prematurely discontinued due to futility on 27 September 2010. No new or unexpected safety issues were identified.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00676650
First received: May 8, 2008
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.


Condition Intervention Phase
Prostatic Neoplasms
Drug: Prednisone
Drug: sunitinib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline up to 32 months ] [ Designated as safety issue: No ]
    OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline, every 8 weeks up to 123 weeks ] [ Designated as safety issue: No ]
    PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02

  • Percent of Participants With Objective Response (OR) [ Time Frame: Baseline, every 8 weeks up to 123 weeks ] [ Designated as safety issue: No ]
    OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.

  • Duration of Response (DR) [ Time Frame: Baseline, every 8 weeks up to 123 weeks ] [ Designated as safety issue: No ]
    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response

  • Change From Baseline in Pain Severity [ Time Frame: Day 1 through Day 7 every 28 days (every cycle) up to 29 months ] [ Designated as safety issue: No ]
    Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.

  • Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: Baseline, every 4 weeks up to 123 weeks ] [ Designated as safety issue: No ]
    FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.

  • Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Baseline, every 4 weeks up to 123 weeks ] [ Designated as safety issue: No ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.


Enrollment: 873
Study Start Date: July 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Treatment Arm A - sunitinib + prednisone
Drug: Prednisone
5 mg BID, oral
Other Name: Deltasone
Drug: sunitinib
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Other Name: Sutent, SU011248
Placebo Comparator: B
Treatment Arm B - placebo + prednisone
Drug: Placebo
37.5 mg/day, oral, administered on a continuous daily dosing regimen
Drug: Prednisone
5 mg BID, oral
Other Name: Deltasone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
  • Progressive disease based on PSA progression, RECIST, or positive bone scan.
  • ECOG 0 or 1.

Exclusion Criteria:

  • Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
  • Chemotherapy within 3 weeks.
  • Impending complications from bone metastases.
  • Ongoing urinary obstruction.
  • Cardiac dysfunction, QTc >470 msec.
  • CNS involvement.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676650

  Show 205 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00676650     History of Changes
Other Study ID Numbers: A6181120
Study First Received: May 8, 2008
Results First Received: December 20, 2012
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Docetaxel-refractory mCRPC
Second-line treatment with sunitinib and prednisone

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Prednisone
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Growth Inhibitors
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014