Clinical Trial Results:
Phase II study of thalidomide in combination with temozolomide in metastatic malignant melanoma with brain metastases
Summary
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EudraCT number |
2004-005164-25 |
Trial protocol |
DK |
Global end of trial date |
04 Dec 2007
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Jul 2021
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First version publication date |
21 Jul 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
04.09
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
J. B. Winsløws vej 2, entrance 140, basement, Odense C, Denmark, 5000
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Public contact |
Ida Coordt Elle, Odense University Hospital, +45 29335922, ida.coordt.elle@rsyd.dk
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Scientific contact |
Lars Bastholt, Odense University Hospital, +45 24849408, lars.bastholt@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jul 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Dec 2007
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine tumor response rate including determination of stable disease
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Protection of trial subjects |
Treatment with steroids if necessary.
Pre-medication to minimize adverse events.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2004
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
30
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From 65 to 84 years |
10
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85 years and over |
0
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Recruitment
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Recruitment details |
All patients included in the study had brain metastases in progression not amenable for surgery or stereotactic radiotherapy and due to limited symptoms whole brain radiotherapy was not indicated. WHO performance status (PS) ≤ 0.1. | ||||||
Pre-assignment
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Screening details |
Forty screened patients were eligible and evaluable for response, and 39 were evaluable for toxicity. 25 patients had asymptomatic and 15 symptomatic brain metastases. | ||||||
Period 1
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Period 1 title |
Trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Tem-Thal | ||||||
Arm description |
TMZ in a dose of 150 mg/m2 qd for seven days, followed by seven days off therapy and THA in 200 mg qd, both orally administered. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Temozolomide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
150 mg/m2 qd for seven days, followed by seven days off therapy.
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Investigational medicinal product name |
Thalidomide
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Starting dose of THA was 100 mg qd orally, taken in the evening to reduce drug-related daytime somnolence. The dose was escalated after
one week to a maximum of 200 mg qd given continuously.
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Baseline characteristics reporting groups
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Reporting group title |
Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Patients
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Forty screened patients were eligible and evaluable for response, and 39 were evaluable for toxicity. 25 patients had asymptomatic and 15 symptomatic brain metastases.
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End points reporting groups
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Reporting group title |
Tem-Thal
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Reporting group description |
TMZ in a dose of 150 mg/m2 qd for seven days, followed by seven days off therapy and THA in 200 mg qd, both orally administered. | ||
Subject analysis set title |
Patients
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Forty screened patients were eligible and evaluable for response, and 39 were evaluable for toxicity. 25 patients had asymptomatic and 15 symptomatic brain metastases.
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End point title |
Response rate (CR+PR+SD) [1] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 months
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Please see attached publication for full statistical analysis. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
30 days post-last treatment
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.0
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Reporting groups
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Reporting group title |
Patients
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/22275974 |