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
11
2
10
1.5
0.1

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 Disease Intervention/Treatment Phase
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

Arm Intervention/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

Site City State Country Postal Code
1 American Institute of Research Whittier California United States 90603
2 Joliet Oncology Hematology Associates Joliet Illinois United States 60435
3 Oncology Specialists SC Niles Illinois United States 60714
4 Massachusetts General Hospital Boston Massachusetts United States 02114
5 Henry Ford Health System Detroit Michigan United States 84202
6 AZ Sint-Augustinus Wilrijk Belgium 2610
7 Cancer Hospital, Academy of Med Science and Peking Union Med Beijing Beijing China 100021
8 UNIMED Medical Institute Hong Kong Hong Kong
9 Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly Budapest Hungary 1122
10 Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdr Warszawa Poland 04125
11 Johns Hopkins Singapore International Medical Centre Singapore Singapore 308433

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 Detail Study 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 Title Bosutinib + Letrozole (Part 1)
Arm/Group Description Four 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
STARTED 16
COMPLETED 0
NOT COMPLETED 16

Baseline Characteristics

Arm/Group Title Bosutinib + Letrozole (Part 1)
Arm/Group Description Four 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 Participants 16
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
Title Progression-Free Survival (PFS) Based on Independent Radiologist
Description 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.
Time Frame Part 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 Title Bosutinib + Letrozole (Part 2) Letrozole (Part 2)
Arm/Group Description Four 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 Participants 0 0
2. Secondary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description 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.
Time Frame Part 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 Title Bosutinib + Letrozole (Part 1)
Arm/Group Description Four 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 Participants 16
AEs
100
625%
SAEs
31.3
195.6%
3. Secondary Outcome
Title Progression-Free Survival (PFS) Based on Investigator
Description 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.
Time Frame Part 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 Title Bosutinib + Letrozole (Part 2) Letrozole (Part 2)
Arm/Group Description Four 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 Participants 0 0
4. Secondary Outcome
Title Percentage of Participants With Objective Response
Description 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.
Time Frame Part 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 Title Bosutinib + Letrozole (Part 2) Letrozole (Part 2)
Arm/Group Description Four 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 Participants 0 0
5. Secondary Outcome
Title Overall Survival (OS)
Description 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).
Time Frame Part 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 Title Bosutinib + Letrozole (Part 2) Letrozole (Part 2)
Arm/Group Description Four 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 Participants 0 0
6. Secondary Outcome
Title Duration of Response (DR)
Description 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.
Time Frame Part 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 Title Bosutinib + Letrozole (Part 2) Letrozole (Part 2)
Arm/Group Description Four 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 Participants 0 0
7. Secondary Outcome
Title Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
Description 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.
Time Frame Part 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 Title Bosutinib + Letrozole (Part 2) Letrozole (Part 2)
Arm/Group Description Four 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 Participants 0 0
8. Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Description
Time Frame 0 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 Title Bosutinib + Letrozole (Part 2) Letrozole (Part 2)
Arm/Group Description Four 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 Participants 0 0
9. Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Description
Time Frame 0 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 Title Bosutinib + Letrozole (Part 2) Letrozole (Part 2)
Arm/Group Description Four 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 Participants 0 0
10. Secondary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]
Description AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).
Time Frame 0 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 Title Bosutinib + Letrozole (Part 2) Letrozole (Part 2)
Arm/Group Description Four 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 Participants 0 0

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 Title Bosutinib + Letrozole (Part 1)
Arm/Group Description Four 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
Total 5/16 (31.3%)
Cardiac disorders
Myocardial ischaemia 1/16 (6.3%)
Gastrointestinal disorders
Diarrhea 1/16 (6.3%)
Vomiting 1/16 (6.3%)
General disorders
Pyrexia 1/16 (6.3%)
Hepatobiliary disorders
Cholecystitis chronic 1/16 (6.3%)
Cholelithiasis 1/16 (6.3%)
Injury, poisoning and procedural complications
Accidental overdose 1/16 (6.3%)
Investigations
Alanine aminotransferase increased 2/16 (12.5%)
Aspartate aminotransferase increased 1/16 (6.3%)
Metabolism and nutrition disorders
Hypokalemia 1/16 (6.3%)
Skin and subcutaneous tissue disorders
Rash 1/16 (6.3%)
Other (Not Including Serious) Adverse Events
Bosutinib + Letrozole (Part 1)
Affected / at Risk (%) # Events
Total 16/16 (100%)
Blood and lymphatic system disorders
Lymphopenia 2/16 (12.5%)
Gastrointestinal disorders
Abdominal pain 1/16 (6.3%)
Abdominal pain upper 2/16 (12.5%)
Constipation 2/16 (12.5%)
Diarrhoea 13/16 (81.3%)
Dry mouth 1/16 (6.3%)
Dyspepsia 2/16 (12.5%)
Nausea 7/16 (43.8%)
Vomiting 7/16 (43.8%)
General disorders
Chest discomfort 1/16 (6.3%)
Chills 1/16 (6.3%)
Fatigue 4/16 (25%)
Malaise 1/16 (6.3%)
Oedema peripheral 1/16 (6.3%)
Pyrexia 1/16 (6.3%)
Infections and infestations
Upper respiratory tract infection 1/16 (6.3%)
Viral upper respiratory tract infection 1/16 (6.3%)
Injury, poisoning and procedural complications
Post procedural diarrhoea 1/16 (6.3%)
Investigations
Alanine aminotransferase increased 6/16 (37.5%)
Aspartate aminotransferase increased 4/16 (25%)
Blood bilirubin increased 1/16 (6.3%)
Blood creatinine 1/16 (6.3%)
Eosinophil count increased 1/16 (6.3%)
Metabolism and nutrition disorders
Decreased appetite 2/16 (12.5%)
Dehydration 1/16 (6.3%)
Hyperkalaemia 1/16 (6.3%)
Hypocalcaemia 2/16 (12.5%)
Hyponatraemia 2/16 (12.5%)
Hypophosphataemia 1/16 (6.3%)
Musculoskeletal and connective tissue disorders
Back pain 1/16 (6.3%)
Bone pain 1/16 (6.3%)
Musculoskeletal chest pain 2/16 (12.5%)
Musculoskeletal pain 1/16 (6.3%)
Myalgia 1/16 (6.3%)
Nervous system disorders
Headache 3/16 (18.8%)
Psychiatric disorders
Anxiety 1/16 (6.3%)
Renal and urinary disorders
Hydronephrosis 1/16 (6.3%)
Proteinuria 2/16 (12.5%)
Reproductive system and breast disorders
Vaginal haemorrhage 1/16 (6.3%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea 4/16 (25%)
Skin and subcutaneous tissue disorders
Alopecia 3/16 (18.8%)
Dry skin 1/16 (6.3%)
Pruritus 1/16 (6.3%)
Rash 6/16 (37.5%)
Vascular disorders
Deep vein thrombosis 1/16 (6.3%)
Hot flush 3/16 (18.8%)
Hypertension 3/16 (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/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.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