Clinical trial NCT01376310: GSK1120212 Rollover Study
Official title: MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was an open-label study to permit subjects with solid tumors or leukemia, who were clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.


Eligibility criteria: Inclusion Criteria:

1. Has provided signed informed consent for this study.
2. Has demonstrated compliance during the parent study with study treatment(s), treatment visit schedules, and the requirements and restrictions listed in the consent form.
3. Is currently participating in GSK1120212 study and is receiving treatment with GSK1120212.
4. Is currently receiving clinical benefit as determined by the investigator from previous treatment with GSK1120212 either as monotherapy or as part of a combination treatment regimen.
5. Continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
6. Female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 months after the last dose of GSK1120212.
7. Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.
8. Subjects enrolled in France: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

1. Permanent discontinuation of GSK1120212 in the parent study due to toxicity or disease progression.
2. Current use of a prohibitive medication(s) as listed in Section 6.2. NOTE: Use of anticoagulants such as warfarin is permitted; however, the international normalization ratio (INR) must be monitored in accordance with local institutional practice.
3. Any unresolved toxicity that meets the study treatment discontinuation or study withdrawal criteria from the parent study at the time of transition to this study.
4. Bazett-corrected QT (QTcB) interval ≥501 msec at the time of transition to this study
5. Left ventricular ejection fraction (LVEF) \< institutional lower limit of normal (LLN) by ECHO (preferred) or MUGA scan at the time of transition to this study.
6. Nursing female.
7. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor.

   -

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Until 30 days after the last dose of study treatment. Subjects may have continued to receive study treatment until disease progression, death, unacceptable toxicity or until locally commercially available. The maximum duration of exposure was 76 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Scottsdale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Aurora
country: United States
facility: Novartis Investigative Site
state: Colorado
city: New Haven
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toulouse Cedex 9
country: France
facility: Novartis Investigative Site
city: Villejuif Cedex
country: France
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: