A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
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ClinicalTrials.gov Identifier: NCT01227889 |
Recruitment Status :
Completed
First Posted : October 25, 2010
Results First Posted : May 16, 2014
Last Update Posted : October 4, 2017
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Cancer |
Interventions |
Drug: GSK2118436 Drug: Dacarbazine (DTIC) |
Enrollment | 251 |
Participant Flow
Recruitment Details | This was a Phase III randomized, open-label study to compare GSK2118436 to Dacarbazine (DTIC) in previously untreated participants (par.) with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma. This study was conducted at 70 centers in 12 countries. |
Pre-assignment Details | The study has 2 phases: Randomized and Crossover Phase. In Randomized Phase, a total of 250 par. were randomized in 3:1 to receive either oral dabrafenib 150 mg twice daily (BID) or intravenous DTIC 1000 milligram/meter square. Par. in DTIC arm with disease progression were considered for crossover to dabrafenib arm in Crossover Phase |
Arm/Group Title | GSK2118436 150 mg BID | DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase |
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Participants (par.) were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor. | In the RP, par. received intravenous (IV) Dacarbazine (DTIC) 1000 mg per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy. |
Period Title: Randomized Phase (RP) | ||
Started | 187 | 63 |
Completed | 0 | 0 |
Not Completed | 187 | 63 |
Reason Not Completed | ||
Adverse Event | 13 | 0 |
Physician Decision | 13 | 5 |
Progressive Disease | 135 | 52 |
Study terminated by sponsor | 10 | 0 |
Missing | 1 | 3 |
Withdrawal by Subject | 15 | 3 |
Period Title: Crossover Phase | ||
Started | 0 | 37 [1] |
Completed | 0 | 0 |
Not Completed | 0 | 37 |
Reason Not Completed | ||
Adverse Event | 0 | 1 |
Physician Decision | 0 | 3 |
Progressive Disease | 0 | 31 |
Study Terminated By Sponsor | 0 | 1 |
Withdrawal by Subject | 0 | 1 |
[1]
As of the data cut on December 18, 2012, 36 of 63 participants crossed over from DTIC to GSK2118436.
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Baseline Characteristics
Arm/Group Title | GSK2118436 150 mg BID | DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase | Total | |
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Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor. | In the RP, par. received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy. | Total of all reporting groups | |
Overall Number of Baseline Participants | 187 | 63 | 250 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 187 participants | 63 participants | 250 participants | |
53.5 (13.76) | 51.6 (14.22) | 53.0 (13.87) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 187 participants | 63 participants | 250 participants | |
Female |
75 40.1%
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26 41.3%
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101 40.4%
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Male |
112 59.9%
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37 58.7%
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149 59.6%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 187 participants | 63 participants | 250 participants |
White | 186 | 63 | 249 | |
Missing | 1 | 0 | 1 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01227889 |
Other Study ID Numbers: |
113683 |
First Submitted: | October 21, 2010 |
First Posted: | October 25, 2010 |
Results First Submitted: | June 6, 2013 |
Results First Posted: | May 16, 2014 |
Last Update Posted: | October 4, 2017 |