GSK1120212 Rollover Study

NCT01376310 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 114375
• Study Type: interventional
• Target: 159
• Locations: 6 countries
• Sites: 19

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Cohort A

EXPERIMENTAL

Subjects on GSK1120212 Monotherapy who have been treated less than 24 weeks in their parent study.

Drug: GSK1120212

Cohort B

EXPERIMENTAL

Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.

Drug: GSK1120212; Drug: Docetaxel + GSK1120212; Drug: Erlotinib + GSK1120212; Drug: Pemetrexed + GSK1120212; Drug: Carboplatin + GSK1120212; Drug: Nab-paclitaxel + GSK1120212; Drug: Gemcitabine + GSK1120212; Drug: Everolimus + GSK1120212

Interventions

GSK1120212 DRUG

up to 2 mg/day

Cohort A; Cohort B

Docetaxel + GSK1120212 DRUG

dose as defined in the dose escalation protocol.

Also known as: Taxotere

Cohort B

Erlotinib + GSK1120212 DRUG

dose as defined in the dose escalation protocol.

Also known as: Tarceva

Cohort B

Pemetrexed + GSK1120212 DRUG

dose as defined in the dose escalation protocol

Also known as: Alimta

Cohort B

Carboplatin + GSK1120212 DRUG

dose as defined in the dose escalation protocol

Also known as: Paraplatin

Cohort B

Nab-paclitaxel + GSK1120212 DRUG

dose as defined in the dose escalation protocol

Also known as: Abraxane

Cohort B

Gemcitabine + GSK1120212 DRUG

dose as defined in the dose escalation protocol

Also known as: Gemzar

Cohort B

Everolimus + GSK1120212 DRUG

dose as defined in the dose escalation protocol

Also known as: Afinitor

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided signed informed consent for this study.
• Has demonstrated compliance during the parent study with study treatment(s), treatment visit schedules, and the requirements and restrictions listed in the consent form.
• Is currently participating in GSK1120212 study and is receiving treatment with GSK1120212.
• 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.
• 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.
• 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.
• Female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study.

You may not qualify if:

• Permanent discontinuation of GSK1120212 in the parent study due to toxicity or disease progression.
• 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.
• 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.
• Bazett-corrected QT (QTcB) interval ≥501 msec at the time of transition to this study
• 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.
• Nursing female.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (19)

Novartis Investigative Site

Goodyear, Arizona, 85338, United States

Location

Novartis Investigative Site

Scottsdale, Arizona, 85259, United States

Location

Novartis Investigative Site

Sacramento, California, 95817, United States

Location

Novartis Investigative Site

Aurora, Colorado, 80045, United States

Location

Novartis Investigative Site

New Haven, Connecticut, 06510, United States

Location

Novartis Investigative Site

Sarasota, Florida, 34232, United States

Location

Novartis Investigative Site

New York, New York, 10016, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19104, United States

Location

Novartis Investigative Site

Nashville, Tennessee, 37203, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Salt Lake City, Utah, 84112, United States

Location

Novartis Investigative Site

Tacoma, Washington, 98405, United States

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Villejuif, 94805, France

Location

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

Location

Novartis Investigative Site

Seoul, 135-710, South Korea

Location

Novartis Investigative Site

Taipei, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

trametinib; Docetaxel; Erlotinib Hydrochloride; Pemetrexed; Carboplatin; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Everolimus

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Paclitaxel; Albumins; Proteins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Sirolimus; Macrolides; Lactones

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: June 20, 2011
• Study Start: November 2, 2010
• Primary Completion: January 18, 2018
• Study Completion: January 18, 2018
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-02

Locations

KR (1); TW (1); FR (2); CA (1); NL (1); US (13)