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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01376310
Other study ID # 114375
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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