GSK1120212 Rollover Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01376310
• Date of registration: 03/02/2011
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: GSK1120212 Rollover Study
• Scientific title: MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia
• Date of first enrolment: November 2, 2010
• Target sample size: 159
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01376310
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.

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Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cancer

Intervention(s)

Drug: GSK1120212

Drug: Pemetrexed + GSK1120212

Drug: Erlotinib + GSK1120212

Drug: Everolimus + GSK1120212

Drug: Gemcitabine + GSK1120212

Drug: Nab-paclitaxel + GSK1120212

Drug: Carboplatin + GSK1120212

Drug: Docetaxel + GSK1120212

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: 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 ID(s)

114375

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01376310