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Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00243503
First received: October 20, 2005
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.


Condition Intervention Phase
Breast Neoplasms
Drug: SU011248/Trastuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Overall Confirmed Objective Disease Response [ Time Frame: From start of treatment through 18 months ] [ Designated as safety issue: No ]
    Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.


Secondary Outcome Measures:
  • Duration of Response (DR) [ Time Frame: From start of treatment through 18 months ] [ Designated as safety issue: No ]
    Time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of objective tumor progression or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DR was calculated as (the end date for DR minus first CR or PR that was subsequently confirmed +1) divided by 7.

  • Percentage of Participants With Clinical Benefit [ Time Frame: From start of treatment through 18 months ] [ Designated as safety issue: No ]
    Percent of participants with confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST.CR was defined as disappearance of all target and non-target lesions.PR was defined as >=30% decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions associated to non-progressive disease response for non target lesions.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started.

  • Progression Free Survival (PFS) [ Time Frame: From start of treatment through 18 months ] [ Designated as safety issue: No ]
    Time from first dose of study treatment to first documentation of objective tumor progression, or to death on-study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was calculated as (first event date minus first dose date +1) divided by 7.

  • Time to Progression (TTP) [ Time Frame: From start of treatment through 18 months ] [ Designated as safety issue: No ]
    Time from first dose of study treatment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was calculated as (first event date minus first dose date +1) divided by 7.

  • Overall Survival (OS) [ Time Frame: From start of study treatment until death or 2 years from first study treatment ] [ Designated as safety issue: No ]
    Time from first dose of study treatment to first documentation of death due to any cause. OS was calculated as (date of death minus first dose date +1) divided by 7 * 4.33.

  • Probability of Survival at One Year [ Time Frame: From start of study treatment until death or 2 years from first study treatment ] [ Designated as safety issue: No ]
    One- year survival probability was estimated using the Kaplan-Meier method.

  • EORTC QLQ-C30 [ Time Frame: From start of treatment through 18 months ] [ Designated as safety issue: No ]
    EORTC QLQ-C30 scales consist of 30 questions: functional (physical/role/cognitive/emotional/ social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.

  • EORTC QLQ (BR23) [ Time Frame: From start of treatment through 18 months ] [ Designated as safety issue: No ]
    BR23: consisted of 23 questions which measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

  • Dose-corrected Trough Plasma Concentrations (Ctrough) of Sunitinib [ Time Frame: Predose on Day 1 of Cycle 3 and 5 ] [ Designated as safety issue: No ]
    Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.

  • Dose-corrected Ctrough of SU-012662 (Sunitinib's Metabolite) [ Time Frame: Predose on Day 1 of Cycle 3 and 5 ] [ Designated as safety issue: No ]
    Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.

  • Dose-corrected Ctrough of Total Drug (Sunitinib + SU-012662) [ Time Frame: Predose on Day 1 of Cycle 3 and 5 ] [ Designated as safety issue: No ]
    Ctrough = the concentration prior to study drug administration. Dose-corrected values were reported, the reference dose was 37.5 mg.


Enrollment: 60
Study Start Date: February 2006
Study Completion Date: July 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: SU011248/Trastuzumab
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.

  Eligibility

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

Inclusion Criteria:

  • A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
  • HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
  • Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

Exclusion Criteria:

  • Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
  • Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
  • Prior treatment on a SU11248 clinical trial.  
  • Uncontrolled brain metastases.   
  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: NCT00243503

  Show 27 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: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00243503     History of Changes
Other Study ID Numbers: A6181067
Study First Received: October 20, 2005
Results First Received: April 20, 2010
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Breast Cancer Metastatic

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Sunitinib
Trastuzumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014