An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00425854
Collaborator
(none)
50
14
1
3.6
Study Details
Study Description
Brief Summary
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
Study Start Date
:
Nov 1, 2006
Actual Primary Completion Date
:
May 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BIBW 2992 high dose once daily |
Drug: BIBW 2992
high dose once daily
|
Outcome Measures
Primary Outcome Measures
- Objective Response (OR) [Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.]
OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.
- Clinical Benefit (CB) [Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.]
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.
Secondary Outcome Measures
- Clinical Benefit (CB) [Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.]
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A.
- Time to OR [Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.]
The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.
- Duration of OR [Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.]
Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.
- Progression-free Survival (PFS) [Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.]
PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.
- Overall Survival (OS) [From randomisation to end of follow-up.]
OS is defined as time from randomisation to death.
- Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF) [Baseline and last assessment]
LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent.
- Best Change From Baseline in ECOG Performance Status [baseline till end of treatment]
Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead).
- Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29) [day 29]
Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion criteria:
Inclusion Criteria:
-
Female patients age 18 years or older
-
Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
-
HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
-
At least one measurable tumour lesion (RECIST);
-
Availability of tumour samples
-
Written informed consent that is consistent with ICH-GCP guidelines and local law
-
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 - 2.
Exclusion criteria:
Exclusion Criteria:
-
Active infectious disease
-
Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
-
Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
-
Active/symptomatic brain metastases
-
Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
-
ANC less than 1500/mm3 platelet count less than 100 000/mm3
-
Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)
-
AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
-
Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)
-
Patients who are sexually active and unwilling to use a medically acceptable method of contraception
-
Pregnancy or breast-feeding
-
Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
-
Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
-
Active alcohol or drug abuse
-
Other malignancy within the past 5 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1200.10.3208 Boehringer Ingelheim Investigational Site | Brussel | Belgium | ||
| 2 | 1200.10.3201 Boehringer Ingelheim Investigational Site | Bruxelles | Belgium | ||
| 3 | 1200.10.3203 Boehringer Ingelheim Investigational Site | Charleroi | Belgium | ||
| 4 | 1200.10.3205 Boehringer Ingelheim Investigational Site | Gent | Belgium | ||
| 5 | 1200.10.3204 Boehringer Ingelheim Investigational Site | Leuven | Belgium | ||
| 6 | 1200.10.3206 Boehringer Ingelheim Investigational Site | Wilrijk | Belgium | ||
| 7 | 1200.10.49005 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 8 | 1200.10.49007 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany | ||
| 9 | 1200.10.49008 Boehringer Ingelheim Investigational Site | Erlangen | Germany | ||
| 10 | 1200.10.49010 Boehringer Ingelheim Investigational Site | Essen | Germany | ||
| 11 | 1200.10.49003 Boehringer Ingelheim Investigational Site | Kiel | Germany | ||
| 12 | 1200.10.49004 Boehringer Ingelheim Investigational Site | Mainz | Germany | ||
| 13 | 1200.10.49001 Boehringer Ingelheim Investigational Site | München | Germany | ||
| 14 | 1200.10.49006 Boehringer Ingelheim Investigational Site | Wiesbaden | Germany |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00425854
Other Study ID Numbers:
- 1200.10
- 2006-002018-36
First Posted:
Jan 23, 2007
Last Update Posted:
Dec 31, 2013
Last Verified:
Aug 1, 2013
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort A | Cohort B |
|---|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Period Title: Overall Study | ||
| STARTED | 29 | 21 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 29 | 21 |
Baseline Characteristics
| Arm/Group Title | Cohort A | Cohort B | Total |
|---|---|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd | Total of all reporting groups |
| Overall Participants | 29 | 21 | 50 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
54.3
(11.5)
|
61.0
(14.3)
|
57.1
(13.0)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
29
100%
|
21
100%
|
50
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Clinical Benefit (CB) |
|---|---|
| Description | CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was secondary endpoint only for Cohort B as it was primary endpoint for Cohort A. |
| Time Frame | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS. No data for Cohort A as CB was secondary endpoint only for Cohort B. |
| Arm/Group Title | Cohort B |
|---|---|
| Arm/Group Description | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Measure Participants | 21 |
| With CB |
1
3.4%
|
| Without CB |
17
58.6%
|
| missing |
3
10.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Maximum Likelihood |
| Estimated Value | 0.048 | |
| Confidence Interval |
(2-Sided) 95% 0.001 to 0.238 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort B. The CI is an exact Clopper Pearson CI. | |
| Title | Time to OR |
|---|---|
| Description | The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria. |
| Time Frame | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS. Median time to OR was not calcuable as there was no OR observed. |
| Arm/Group Title | Cohort A | Cohort B |
|---|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Measure Participants | 0 | 0 |
| Title | Duration of OR |
|---|---|
| Description | Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented. |
| Time Frame | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS. Median duration of OR was not calcuable as there was no OR observed. |
| Arm/Group Title | Cohort A | Cohort B |
|---|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Measure Participants | 0 | 0 |
| Title | Progression-free Survival (PFS) |
|---|---|
| Description | PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0 criteria as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates. |
| Time Frame | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Cohort A | Cohort B |
|---|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Measure Participants | 29 | 21 |
| Median (95% Confidence Interval) [days] |
52
|
54
|
| Title | Objective Response (OR) |
|---|---|
| Description | OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B. |
| Time Frame | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication. No data for Cohort A as OR was primary endpoint only for Cohort B. |
| Arm/Group Title | Cohort B |
|---|---|
| Arm/Group Description | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Measure Participants | 21 |
| Number [Participants with OR] |
0
0%
|
| Title | Clinical Benefit (CB) |
|---|---|
| Description | CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A. |
| Time Frame | Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter. |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS. No data for Cohort B as CB was primary endpoint only for Cohort A. |
| Arm/Group Title | Cohort A |
|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) |
| Measure Participants | 29 |
| With CB |
3
10.3%
|
| Without CB |
24
82.8%
|
| missing |
2
6.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Cohort B |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Clinical benefit rate |
| Estimated Value | 0.10 | |
| Confidence Interval |
(2-Sided) 95% 0.02 to 0.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort A. The confidence interval (CI) is an exact Clopper Pearson CI. | |
| Title | Overall Survival (OS) |
|---|---|
| Description | OS is defined as time from randomisation to death. |
| Time Frame | From randomisation to end of follow-up. |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS. As only 9 patient (31 percent) of Cohort A had died the median OS time was not estimable for Cohort A. |
| Arm/Group Title | Cohort A | Cohort B |
|---|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Measure Participants | 29 | 21 |
| Median (95% Confidence Interval) [days] |
NA
|
448
|
| Title | Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF) |
|---|---|
| Description | LVEF as measured by echocardiography or Multiple Gated Acquisition (MUGA) scan. MUGA scan is an useful noninvasive tool for assessing the function of the heart. Significant change in LVEF values was defined as >=20 percent decrease from baseline or to below lower limit of normal, which was defined as 50 percent. |
| Time Frame | Baseline and last assessment |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Cohort A | Cohort B |
|---|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Measure Participants | 29 | 21 |
| Number [Participants] |
1
3.4%
|
2
9.5%
|
| Title | Best Change From Baseline in ECOG Performance Status |
|---|---|
| Description | Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). |
| Time Frame | baseline till end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort A | Cohort B |
|---|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Measure Participants | 29 | 21 |
| improved |
1
3.4%
|
0
0%
|
| deteriorated |
15
51.7%
|
13
61.9%
|
| Title | Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29) |
|---|---|
| Description | Cpre,ss,29 represents the pre-dose concentration of afatinib in plasma at steady state on day 29. |
| Time Frame | day 29 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort A | Cohort B |
|---|---|---|
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd |
| Measure Participants | 10 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
33.1
(110)
|
22.9
(64.7)
|
Adverse Events
| Time Frame | First administration of trial medication until 28 days after last administration of trial medication | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Cohort A | Cohort B | ||
| Arm/Group Description | Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd) | Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd | ||
All Cause Mortality |
||||
| Cohort A | Cohort B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Cohort A | Cohort B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/29 (44.8%) | 7/21 (33.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/29 (3.4%) | 0/21 (0%) | ||
| Febrile neutropenia | 1/29 (3.4%) | 0/21 (0%) | ||
| Ear and labyrinth disorders | ||||
| Meniere's disease | 1/29 (3.4%) | 0/21 (0%) | ||
| Eye disorders | ||||
| Eyelid ptosis | 1/29 (3.4%) | 0/21 (0%) | ||
| Miosis | 1/29 (3.4%) | 0/21 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/29 (0%) | 1/21 (4.8%) | ||
| Diarrhoea | 3/29 (10.3%) | 2/21 (9.5%) | ||
| Dysphagia | 0/29 (0%) | 1/21 (4.8%) | ||
| Nausea | 0/29 (0%) | 2/21 (9.5%) | ||
| Oesophageal stenosis | 0/29 (0%) | 1/21 (4.8%) | ||
| Vomiting | 2/29 (6.9%) | 0/21 (0%) | ||
| General disorders | ||||
| Fatigue | 0/29 (0%) | 1/21 (4.8%) | ||
| General physical health deterioration | 5/29 (17.2%) | 0/21 (0%) | ||
| Mucosal inflammation | 0/29 (0%) | 1/21 (4.8%) | ||
| Pain | 0/29 (0%) | 1/21 (4.8%) | ||
| Pyrexia | 0/29 (0%) | 1/21 (4.8%) | ||
| Hepatobiliary disorders | ||||
| Bile duct obstruction | 1/29 (3.4%) | 0/21 (0%) | ||
| Jaundice | 1/29 (3.4%) | 0/21 (0%) | ||
| Infections and infestations | ||||
| Abscess rupture | 1/29 (3.4%) | 0/21 (0%) | ||
| Bronchopneumonia | 1/29 (3.4%) | 0/21 (0%) | ||
| Investigations | ||||
| Hepatic enzyme increased | 0/29 (0%) | 1/21 (4.8%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 2/29 (6.9%) | 1/21 (4.8%) | ||
| Hypokalaemia | 1/29 (3.4%) | 0/21 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Malignant neoplasm progression | 2/29 (6.9%) | 2/21 (9.5%) | ||
| Metastatic pain | 1/29 (3.4%) | 0/21 (0%) | ||
| Nervous system disorders | ||||
| Peripheral motor neuropathy | 0/29 (0%) | 1/21 (4.8%) | ||
| VIth nerve paralysis | 1/29 (3.4%) | 0/21 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 0/29 (0%) | 1/21 (4.8%) | ||
| Pulmonary embolism | 0/29 (0%) | 1/21 (4.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 0/29 (0%) | 1/21 (4.8%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Cohort A | Cohort B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 28/29 (96.6%) | 20/21 (95.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/29 (6.9%) | 0/21 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 2/29 (6.9%) | 0/21 (0%) | ||
| Eye disorders | ||||
| Blepharitis | 0/29 (0%) | 2/21 (9.5%) | ||
| Conjunctivitis | 2/29 (6.9%) | 2/21 (9.5%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 3/29 (10.3%) | 0/21 (0%) | ||
| Diarrhoea | 25/29 (86.2%) | 16/21 (76.2%) | ||
| Dysphagia | 1/29 (3.4%) | 2/21 (9.5%) | ||
| Nausea | 13/29 (44.8%) | 5/21 (23.8%) | ||
| Oral pain | 2/29 (6.9%) | 1/21 (4.8%) | ||
| Stomatitis | 5/29 (17.2%) | 2/21 (9.5%) | ||
| Vomiting | 4/29 (13.8%) | 6/21 (28.6%) | ||
| General disorders | ||||
| Fatigue | 9/29 (31%) | 7/21 (33.3%) | ||
| Mucosal inflammation | 9/29 (31%) | 6/21 (28.6%) | ||
| Pain | 1/29 (3.4%) | 2/21 (9.5%) | ||
| Investigations | ||||
| Weight decreased | 3/29 (10.3%) | 0/21 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 8/29 (27.6%) | 6/21 (28.6%) | ||
| Hypokalaemia | 1/29 (3.4%) | 2/21 (9.5%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 3/29 (10.3%) | 0/21 (0%) | ||
| Nervous system disorders | ||||
| Dysgeusia | 2/29 (6.9%) | 2/21 (9.5%) | ||
| Headache | 2/29 (6.9%) | 0/21 (0%) | ||
| Paraesthesia | 2/29 (6.9%) | 0/21 (0%) | ||
| Psychiatric disorders | ||||
| Insomnia | 2/29 (6.9%) | 0/21 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/29 (3.4%) | 3/21 (14.3%) | ||
| Dyspnoea | 3/29 (10.3%) | 3/21 (14.3%) | ||
| Epistaxis | 6/29 (20.7%) | 4/21 (19%) | ||
| Nasal dryness | 2/29 (6.9%) | 1/21 (4.8%) | ||
| Oropharyngeal pain | 1/29 (3.4%) | 3/21 (14.3%) | ||
| Rhinorrhoea | 2/29 (6.9%) | 1/21 (4.8%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 11/29 (37.9%) | 3/21 (14.3%) | ||
| Dermatitis acneiform | 1/29 (3.4%) | 3/21 (14.3%) | ||
| Dry skin | 8/29 (27.6%) | 4/21 (19%) | ||
| Palmar-plantar erythrodysaesthesia syndrome | 1/29 (3.4%) | 5/21 (23.8%) | ||
| Pruritus | 3/29 (10.3%) | 1/21 (4.8%) | ||
| Rash | 9/29 (31%) | 10/21 (47.6%) | ||
| Skin fissures | 2/29 (6.9%) | 3/21 (14.3%) | ||
| Xeroderma | 0/29 (0%) | 2/21 (9.5%) | ||
| Vascular disorders | ||||
| Hypertension | 3/29 (10.3%) | 0/21 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim Pharmaceuticals |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00425854
Other Study ID Numbers:
- 1200.10
- 2006-002018-36
First Posted:
Jan 23, 2007
Last Update Posted:
Dec 31, 2013
Last Verified:
Aug 1, 2013