Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00880009
Collaborator
(none)
16
Enrollment
11
Locations
2
Arms
10
Actual Duration (Months)
1.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of patients had treatment related liver events with the majority of severe events resulting in permanent study treatment discontinuation.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB ADMINISTERED IN COMBINATION WITH LETROZOLE VS. LETROZOLE ALONE AS FIRST LINE THERAPY IN POST-MENOPAUSAL WOMEN WITH LOCALLY ADVANCED OR METASTATIC ER+/PR+/HER2- BREAST CANCER.
Actual Study Start Date :
Jul 30, 2009
Actual Primary Completion Date :
May 31, 2010
Actual Study Completion Date :
May 31, 2010

Arms and Interventions

ArmIntervention/Treatment
Experimental: 1

Combination of Bosutinib and Letrozole

Drug: Bosutinib
400mg (4x100)mg tablets once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs

Drug: Letrozole
2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs

Active Comparator: 2

Letrozole

Drug: Letrozole
2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs

Outcome Measures

Primary Outcome Measures

  1. Progression-Free Survival (PFS) Based on Independent Radiologist [Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose]

    Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). PFS assessed by independent radiologist was to be reported.

Secondary Outcome Measures

  1. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part 1 Baseline up to 28 days after the last dose]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

  2. Progression-Free Survival (PFS) Based on Investigator [Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose]

    Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was "Death"). PFS assessed by investigator was to be reported.

  3. Percentage of Participants With Objective Response [Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose]

    Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.

  4. Overall Survival (OS) [Part 2 Baseline until death or up to 36 months]

    Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

  5. Duration of Response (DR) [Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose]

    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

  6. Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) [Part 2 Baseline, Week 12, 24, 52, 2-6 weeks after the last dose]

    FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  7. Maximum Observed Plasma Concentration (Cmax) [0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29]

  8. Time to Reach Maximum Observed Plasma Concentration (Tmax) [0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29]

  9. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] [0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29]

    AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Surgically sterile or post-menopausal women.

  • Confirmed pathologic diagnosis of breast cancer.

  • Locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy.

  • Documented ER+ and/or PgR+ and erbB2- tumor based on most recently analyzed biopsy, as documented by a local laboratory.

  • At least 1 radiologically measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria:
  • Prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior Src inhibitor.

  • Prior endocrine treatment for locally advanced or metastatic breast cancer (up to one prior adjuvant Aromatase Inhibitor (AI) agent/regimen is permitted).

  • More than 1 prior chemotherapy regimen in locally advanced or metastatic breast cancer.

  • Adjuvant endocrine therapy <=12 months prior to day 1 of treatment.

  • Disease refractory (ie, Progressive disease (PD) within 6 months from initiation of therapy) to previous adjuvant antiestrogen therapy.

  • Bone or skin as the only site of disease.

  • Extensive visceral disease or active Central Nervous System (CNS) disease.

  • Any other cancer within 5 years of screening with the exception of ER+ contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.

  • Major surgery or radiotherapy within 14 days of treatment day.

  • Inadequate hepatic/renal/bone marrow function.

  • History of clinically significant or uncontrolled cardiac disease.

  • Serious concurrent illness.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1American Institute of ResearchWhittierCaliforniaUnited States90603
2Joliet Oncology Hematology AssociatesJolietIllinoisUnited States60435
3Oncology Specialists SCNilesIllinoisUnited States60714
4Massachusetts General HospitalBostonMassachusettsUnited States02114
5Henry Ford Health SystemDetroitMichiganUnited States84202
6AZ Sint-AugustinusWilrijkBelgium2610
7Cancer Hospital, Academy of Med Science and Peking Union MedBeijingBeijingChina100021
8UNIMED Medical InstituteHong KongHong Kong
9Orszagos Onkologiai Intezet "B" Belgyogyaszati osztalyBudapestHungary1122
10Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki ZdrWarszawaPoland04125
11Johns Hopkins Singapore International Medical CentreSingaporeSingapore308433

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00880009
Other Study ID Numbers:
  • 3160A6-2207
  • B1871010
  • 2008-006252-21
First Posted:
Apr 13, 2009
Last Update Posted:
Sep 27, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment DetailStudy was pre-maturely terminated after part 1 (safety lead-in phase) of the study and hence, the planned treatments of part 2, bosutinib + letrozole (Part 2) and letrozole (Part 2), were not administered.
Arm/Group TitleBosutinib + Letrozole (Part 1)
Arm/Group DescriptionFour bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Period Title: Overall Study
STARTED16
COMPLETED0
NOT COMPLETED16

Baseline Characteristics

Arm/Group TitleBosutinib + Letrozole (Part 1)
Arm/Group DescriptionFour bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Overall Participants16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
59.6
(9.78)
Sex: Female, Male (Count of Participants)
Female
16
100%
Male
0
0%

Outcome Measures

1. Primary Outcome
TitleProgression-Free Survival (PFS) Based on Independent Radiologist
DescriptionTime in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). PFS assessed by independent radiologist was to be reported.
Time FramePart 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose

Outcome Measure Data

Analysis Population Description
Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 2)Letrozole (Part 2)
Arm/Group DescriptionFour bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants00
2. Secondary Outcome
TitlePercentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
DescriptionAn AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time FramePart 1 Baseline up to 28 days after the last dose

Outcome Measure Data

Analysis Population Description
Safety population included all participants who receive at least 1 dose of study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 1)
Arm/Group DescriptionFour bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants16
AEs
100
625%
SAEs
31.3
195.6%
3. Secondary Outcome
TitleProgression-Free Survival (PFS) Based on Investigator
DescriptionTime in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was "Death"). PFS assessed by investigator was to be reported.
Time FramePart 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose

Outcome Measure Data

Analysis Population Description
Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 2)Letrozole (Part 2)
Arm/Group DescriptionFour bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants00
4. Secondary Outcome
TitlePercentage of Participants With Objective Response
DescriptionPercentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.
Time FramePart 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose

Outcome Measure Data

Analysis Population Description
Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 2)Letrozole (Part 2)
Arm/Group DescriptionFour bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants00
5. Secondary Outcome
TitleOverall Survival (OS)
DescriptionTime in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time FramePart 2 Baseline until death or up to 36 months

Outcome Measure Data

Analysis Population Description
Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 2)Letrozole (Part 2)
Arm/Group DescriptionFour bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants00
6. Secondary Outcome
TitleDuration of Response (DR)
DescriptionTime in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time FramePart 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose

Outcome Measure Data

Analysis Population Description
Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 2)Letrozole (Part 2)
Arm/Group DescriptionFour bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants00
7. Secondary Outcome
TitleFunctional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
DescriptionFACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time FramePart 2 Baseline, Week 12, 24, 52, 2-6 weeks after the last dose

Outcome Measure Data

Analysis Population Description
Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 2)Letrozole (Part 2)
Arm/Group DescriptionFour bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants00
8. Secondary Outcome
TitleMaximum Observed Plasma Concentration (Cmax)
Description
Time Frame0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29

Outcome Measure Data

Analysis Population Description
Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 2)Letrozole (Part 2)
Arm/Group DescriptionFour bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants00
9. Secondary Outcome
TitleTime to Reach Maximum Observed Plasma Concentration (Tmax)
Description
Time Frame0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29

Outcome Measure Data

Analysis Population Description
Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 2)Letrozole (Part 2)
Arm/Group DescriptionFour bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants00
10. Secondary Outcome
TitleArea Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]
DescriptionAUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).
Time Frame0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29

Outcome Measure Data

Analysis Population Description
Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.
Arm/Group TitleBosutinib + Letrozole (Part 2)Letrozole (Part 2)
Arm/Group DescriptionFour bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
Measure Participants00

Adverse Events

Time Frame
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group TitleBosutinib + Letrozole (Part 1)
Arm/Group DescriptionFour bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
All Cause Mortality
Bosutinib + Letrozole (Part 1)
Affected / at Risk (%)# Events
Total/ (NaN)
Serious Adverse Events
Bosutinib + Letrozole (Part 1)
Affected / at Risk (%)# Events
Total5/16 (31.3%)
Cardiac disorders
Myocardial ischaemia1/16 (6.3%)
Gastrointestinal disorders
Diarrhea1/16 (6.3%)
Vomiting1/16 (6.3%)
General disorders
Pyrexia1/16 (6.3%)
Hepatobiliary disorders
Cholecystitis chronic1/16 (6.3%)
Cholelithiasis1/16 (6.3%)
Injury, poisoning and procedural complications
Accidental overdose1/16 (6.3%)
Investigations
Alanine aminotransferase increased2/16 (12.5%)
Aspartate aminotransferase increased1/16 (6.3%)
Metabolism and nutrition disorders
Hypokalemia1/16 (6.3%)
Skin and subcutaneous tissue disorders
Rash1/16 (6.3%)
Other (Not Including Serious) Adverse Events
Bosutinib + Letrozole (Part 1)
Affected / at Risk (%)# Events
Total16/16 (100%)
Blood and lymphatic system disorders
Lymphopenia2/16 (12.5%)
Gastrointestinal disorders
Abdominal pain1/16 (6.3%)
Abdominal pain upper2/16 (12.5%)
Constipation2/16 (12.5%)
Diarrhoea13/16 (81.3%)
Dry mouth1/16 (6.3%)
Dyspepsia2/16 (12.5%)
Nausea7/16 (43.8%)
Vomiting7/16 (43.8%)
General disorders
Chest discomfort1/16 (6.3%)
Chills1/16 (6.3%)
Fatigue4/16 (25%)
Malaise1/16 (6.3%)
Oedema peripheral1/16 (6.3%)
Pyrexia1/16 (6.3%)
Infections and infestations
Upper respiratory tract infection1/16 (6.3%)
Viral upper respiratory tract infection1/16 (6.3%)
Injury, poisoning and procedural complications
Post procedural diarrhoea1/16 (6.3%)
Investigations
Alanine aminotransferase increased6/16 (37.5%)
Aspartate aminotransferase increased4/16 (25%)
Blood bilirubin increased1/16 (6.3%)
Blood creatinine1/16 (6.3%)
Eosinophil count increased1/16 (6.3%)
Metabolism and nutrition disorders
Decreased appetite2/16 (12.5%)
Dehydration1/16 (6.3%)
Hyperkalaemia1/16 (6.3%)
Hypocalcaemia2/16 (12.5%)
Hyponatraemia2/16 (12.5%)
Hypophosphataemia1/16 (6.3%)
Musculoskeletal and connective tissue disorders
Back pain1/16 (6.3%)
Bone pain1/16 (6.3%)
Musculoskeletal chest pain2/16 (12.5%)
Musculoskeletal pain1/16 (6.3%)
Myalgia1/16 (6.3%)
Nervous system disorders
Headache3/16 (18.8%)
Psychiatric disorders
Anxiety1/16 (6.3%)
Renal and urinary disorders
Hydronephrosis1/16 (6.3%)
Proteinuria2/16 (12.5%)
Reproductive system and breast disorders
Vaginal haemorrhage1/16 (6.3%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea4/16 (25%)
Skin and subcutaneous tissue disorders
Alopecia3/16 (18.8%)
Dry skin1/16 (6.3%)
Pruritus1/16 (6.3%)
Rash6/16 (37.5%)
Vascular disorders
Deep vein thrombosis1/16 (6.3%)
Hot flush3/16 (18.8%)
Hypertension3/16 (18.8%)

Limitations/Caveats

Results are not provided because the study was terminated prior to part 2 due to unfavorable risk benefit ratio of the study treatment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/TitlePfizer ClinicalTrials.gov Call Center
OrganizationPfizer, Inc.
Phone1-800-718-1021
EmailClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00880009
Other Study ID Numbers:
  • 3160A6-2207
  • B1871010
  • 2008-006252-21
First Posted:
Apr 13, 2009
Last Update Posted:
Sep 27, 2021
Last Verified:
Aug 1, 2021