GSK1120212 Rollover Study

Cancer Clinical Trial

Official title:

MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01376310
• Other study ID #: 114375
• Status: Terminated
• Phase: Phase 2
• Start date: November 2, 2010
• Est. completion date: January 18, 2018

Study information

• Verified date: February 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 159
• Est. completion date: January 18, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• GSK1120212
up to 2 mg/day
• Docetaxel + GSK1120212
dose as defined in the dose escalation protocol.
• Erlotinib + GSK1120212
dose as defined in the dose escalation protocol.
• Pemetrexed + GSK1120212
dose as defined in the dose escalation protocol
• Carboplatin + GSK1120212
dose as defined in the dose escalation protocol
• Nab-paclitaxel + GSK1120212
dose as defined in the dose escalation protocol
• Gemcitabine + GSK1120212
dose as defined in the dose escalation protocol
• Everolimus + GSK1120212
dose as defined in the dose escalation protocol

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Toronto	Ontario
France	Novartis Investigative Site	Toulouse Cedex 9
France	Novartis Investigative Site	Villejuif Cedex
Korea, Republic of	Novartis Investigative Site	Seoul
Netherlands	Novartis Investigative Site	Groningen
Taiwan	Novartis Investigative Site	Taipei
United States	Novartis Investigative Site	Aurora	Colorado
United States	Novartis Investigative Site	Goodyear	Arizona
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New Haven	Connecticut
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Sarasota	Florida
United States	Novartis Investigative Site	Scottsdale	Arizona
United States	Novartis Investigative Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  France,  Korea, Republic of,  Netherlands,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Number of participants with adverse events as a measure of safety and tolerability	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.