Clinical trial · Interventional
Safety and Tolerability Study of GSK1120212, a MEK Inhibitor, in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
| nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Trametinib (GSK1120212) | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Treatment Group 1
- description
- Trametinib plus Docetaxel
- interventionNames
- Drug: Trametinib (GSK1120212)
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Treatment Group 2
- description
- Trametinib plus Erlotinib
- interventionNames
- Drug: Trametinib (GSK1120212)
- Drug: Erlotinib
- type
- EXPERIMENTAL
- label
- Treatment Group 3
- description
- Trametinib plus Pemetrexed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDGandara 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. PMID 27876675