CancerPhase 1NCT01192165
Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel
A Phase 1 study testing Trametinib (GSK1120212), Docetaxel and Erlotinib in people with Cancer, run by GlaxoSmithKline at 20 sites in 4 countries.
Trial summary
The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Trametinib (GSK1120212), Docetaxel and Erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 14 Sep 2010to 7 Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
- Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
- The subject has a radiographically measurable tumor.
- The subject is able to carry out daily life activities without difficulty.
- The subject is able to swallow and retain oral medication.
- The subject does not have significant side effects from previous anti-cancer treatment.
- The subject has adequate organ and blood cell counts.
- Sexually active subjects must use medically acceptable methods of contraception during the course of the study.
Who cannot join
- The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
- The subject has a brain tumor.
- Current severe, uncontrolled systemic disease.
- History of clinically significant heart, lung, or eye/vision problems.
- The subject has high blood pressure that is not well-controlled with medication.
- The subject has a permanent pacemaker.
- The subject is pregnant or breastfeeding.
- Positive for Hepatitis B, Hepatitis C, or HIV.
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States13 sites
GSK Investigational Site
Albany, New York, 12206
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Denver, Colorado, 80218
GSK Investigational Site
Duarte, California, 91010
GSK Investigational Site
Greenville, South Carolina, 29605
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Las Vegas, Nevada, 89169
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Norfolk, Virginia, 23502
GSK Investigational Site
Sacramento, California, 95817
GSK Investigational Site
Scottsdale, Arizona, 85259
GSK Investigational Site
Tyler, Texas, 75702
GSK Investigational Site
Vancouver, Washington, 98684
France4 sites
GSK Investigational Site
Caen, 14033
GSK Investigational Site
Marseille, 13385
GSK Investigational Site
Saint-Herblain, 44805
GSK Investigational Site
Toulouse, 31052
South Korea2 sites
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 135-710
About this study
Official title: An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel in Subjects With Advanced Solid Tumors
The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.
- Conditions
- Cancer
- Being tested
- Trametinib (GSK1120212), Docetaxel, Erlotinib, Pemetrexed, Carboplatin
- Keywords
- Taxotere, Cisplatin, Carboplatin, Trametinib, GSK1120212, Tarceva, KRAS, Pemetrexed, MEK inhibitor, nab-Paclitaxel, Docetaxel, Alimta, Abraxane, Erlotinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trametinib (GSK1120212)Drug
Investigational small molecule targeted therapy (MEK1/2 inhibitor)
DocetaxelDrug
Chemotherapy
ErlotinibDrug
Small molecule targeted therapy (EGFR inhibitor)
PemetrexedDrug
Chemotherapy
CarboplatinDrug
Chemotherapy
nab-PaclitaxelDrug
Chemotherapy
CisplatinDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Trametinib plus Docetaxel Receives: Drug: Trametinib (GSK1120212); Drug: Docetaxel |
| Treatment Group 2 | Experimental | Trametinib plus Erlotinib Receives: Drug: Trametinib (GSK1120212); Drug: Erlotinib |
| Treatment Group 3 | Experimental | Trametinib plus Pemetrexed Receives: Drug: Trametinib (GSK1120212); Drug: Pemetrexed |
| Treatment Group 4 | Experimental | Trametinib plus Pemetrexed and Carboplatin Receives: Drug: Trametinib (GSK1120212); Drug: Pemetrexed; Drug: Carboplatin |
| Treatment Group 5 | Experimental | Trametinib plus nab-Paclitaxel Receives: Drug: Trametinib (GSK1120212); Drug: nab-Paclitaxel |
| Treatment Group 6 | Experimental | Trametinib plus Pemetrexed and Cisplatin Receives: Drug: Trametinib (GSK1120212); Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination
Measured: Duration of study (approximately 3 years)
Secondary outcomes (2)
To characterize population pharmacokinetic parameters
Measured: Duration of study (approximately 3 years)
To evaluate the anti-tumor activity as assessed by tumor response rate according to RECIST v1.1
Measured: Duration of study (approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study start14 Sep 2010
- Primary completion7 Oct 2013
- Study completion7 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192165
- Sponsor's protocol ID
- 113486
- Other IDs
- 2012-000257-32
- Status last verified
- Nov 2017
- First submitted
- 30 Aug 2010
- Last updated
- 13 Nov 2017
- Results posted
- No
Publications
Gandara DR, Leighl N, Delord JP, Barlesi F, Bennouna J, Zalcman G, Infante JR, Reckamp KL, Kelly K, Shepherd FA, Mazieres J, Janku F, Gardner OS, Mookerjee B, Wu Y, Cox DS, Schramek D, Peddareddigari V, Liu Y, D'Amelio AM Jr, Blumenschein G Jr. A Phase 1/1b Study Evaluating Trametinib Plus Docetaxel or Pemetrexed in Patients With Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Mar;12(3):556-566. doi: 10.1016/j.jtho.2016.11.2218. Epub 2016 Nov 19.
PubMed 27876675
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01192165
- Acronym / sponsor ID
- 113486
- Conditions
- Cancer
- Keywords
- Taxotere, Cisplatin, Carboplatin, Trametinib, GSK1120212, Tarceva, KRAS, Pemetrexed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2010 (actual)
- Primary completion
- 7 Oct 2013 (actual)
- Study completion
- 7 Oct 2013 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: Trametinib (GSK1120212), Drug: DocetaxelTrametinib plus Docetaxel |
| Treatment Group 2 | Experimental | Drug: Trametinib (GSK1120212), Drug: ErlotinibTrametinib plus Erlotinib |
| Treatment Group 3 | Experimental | Drug: Trametinib (GSK1120212), Drug: PemetrexedTrametinib plus Pemetrexed |
| Treatment Group 4 | Experimental | Drug: Trametinib (GSK1120212), Drug: Pemetrexed, Drug: CarboplatinTrametinib plus Pemetrexed and Carboplatin |
| Treatment Group 5 | Experimental | Drug: Trametinib (GSK1120212), Drug: nab-PaclitaxelTrametinib plus nab-Paclitaxel |
| Treatment Group 6 | Experimental | Drug: Trametinib (GSK1120212), Drug: Pemetrexed, Drug: CisplatinTrametinib plus Pemetrexed and Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject has a solid tumor. Expansion cohorts are limited to non-small cell lung cancer and/or pancreatic cancer with or without a KRAS mutation.
- Tumor progression following at least one prior standard therapy, the subject refuses standard therapy, or no standard therapy exists.
- The subject has a radiographically measurable tumor.
- The subject is able to carry out daily life activities without difficulty.
- The subject is able to swallow and retain oral medication.
Key exclusion criteria (8 listed)
- The subject has had major surgery or received certain types of cancer therapy within 2-3 weeks before starting the study.
- The subject has a brain tumor.
- Current severe, uncontrolled systemic disease.
- History of clinically significant heart, lung, or eye/vision problems.
- The subject has high blood pressure that is not well-controlled with medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trametinib (GSK1120212)Investigational small molecule targeted therapy (MEK1/2 inhibitor) | Drug | Treatment Group 1, Treatment Group 2, Treatment Group 3, Treatment Group 4, Treatment Group 5, Treatment Group 6 |
| DocetaxelChemotherapy | Drug | Treatment Group 1 |
| ErlotinibSmall molecule targeted therapy (EGFR inhibitor) | Drug | Treatment Group 2 |
| PemetrexedChemotherapy | Drug | Treatment Group 3, Treatment Group 4, Treatment Group 6 |
| CarboplatinChemotherapy | Drug | Treatment Group 4 |
| nab-PaclitaxelChemotherapy | Drug | Treatment Group 5 |
| CisplatinChemotherapy | Drug | Treatment Group 6 |
Primary outcome
To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination
Time frame: Duration of study (approximately 3 years)
2 secondary outcomes
To characterize population pharmacokinetic parameters
Time frame: Duration of study (approximately 3 years)
To evaluate the anti-tumor activity as assessed by tumor response rate according to RECIST v1.1
Time frame: Duration of study (approximately 3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Derived from this study: PubMed 27876675Gandara DR, Leighl N, Delord JP, Barlesi F, Bennouna J, Zalcman G, Infante JR, Reckamp KL, Kelly K, Shepherd FA, Mazieres J, Janku F, Gardner OS, Mookerjee B, Wu Y, Cox DS, Schramek D, Peddareddigari V, Liu Y, D'Amelio AM Jr, Blumenschein G Jr. A Phase 1/1b Study Evaluating Trametinib Plus Docetaxel or Pemetrexed in Patients With Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Mar;12(3):556-566. doi: 10.1016/j.jtho.2016.11.2218. Epub 2016 Nov 19.
- Results for study 113486 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trametinib (GSK1120212), Docetaxel and Erlotinib in people with Cancer, run by GlaxoSmithKline at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, France, South Korea, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety, tolerability, and recommended phase II dosing regimen of each GSK1120212-based treatment combination (time frame: Duration of study (approximately 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.