Clinical trial · Interventional
MEK Inhibitor MSC1936369B Plus FOLFIRI in Second Line K-Ras Mutated Metastatic Colorectal Cancer (mCRC)
A Double-blind, Randomized, Comparative, Multicenter, Exploratory, and Placebo-controlled Phase II Trial of FOLFIRI Plus MSC1936369B or Placebo With a Safety run-in Part as Second-line Treatment of Metastatic K Ras Mutated Colorectal Cancer Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Conduct the randomized Phase 2 part not recommended due to the achieved MTD for pimasertib (45mg/day) in combination with FOLFIRI
Summary
Brief summary (as posted)
The research trial is testing the experimental treatment pimasertib (MSC1936369B) in combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal cancer subjects. The study will be run in two parts: Part 1, or Safety Run-in Part: Will determine the maximum tolerated dose and the recommended Phase 2 dose (RP2D) of pimasertib combined with FOLFIRI as second-line treatment in subjects with metastatic K Ras mutated colorectal cancer. Part 2 or Phase 2 Randomised Part: Will assess the anti-tumor activity of pimasertib combined with FOLFIRI compared to FOLFIRI with placebo as second-line treatment in metastatic K Ras mutated colorectal cancer subjects. Phase I which Is an open label dose escalation "3+3" cohort, non-randomized, safety Phase II which is a double blind randomized safety/efficacy
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| Pimasertib | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1 or Safety Run-in Part: Pimasertib+FOLFIRI
- interventionNames
- Drug: Pimasertib
- Drug: FOLFIRI
- type
- EXPERIMENTAL
- label
- Part 2 or Phase 2 Randomized part: Pimasertib+FOLFIRI
- description
- Planned, not performed
- interventionNames
- Drug: Pimasertib
- Drug: FOLFIRI
- type
- EXPERIMENTAL
- label
- Part 2 or Phase 2 Randomized part: Placebo+FOLFIRI
- description
- Planned, not performed
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: For Safety Run-in and Part 2 or Phase 2 Randomised Part * Histologically confirmed K-Ras mutated colon/rectum cancer * Subject's disease must have progressed during or after a first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidines based chemotherapy with or without bevacizumab * Evidence of metastatic measurable disease at trial entry as per Response Evaluation Criteria in Solid Tumors. Complete tumor assessment performed within 14 days prior to first trial drug administration * Male/female subjects aged greater than or equal to (\>=) 18 years * Subject has read and understood the informed consent form * Women of childbearing potential must have a negative blood pregnancy test at the screening visit. Subjects and their partners must be willing to avoid pregnancy during the trial Exclusion Criteria: For Safety Run-in and Part 2 or Phase 2 Randomised Part * Bone marrow impairment * Renal impairment * Liver function and liver cell integrity abnormality * History of central nervous system (CNS) metastases * History of difficulty of swallowing, malabsorption or other chronic gastrointestinal disease * Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than (\>)1 * Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B * Has received extensive prior radiotherapy on more than 30 percent (%) of bone marrow reserves, or prior bone marrow/stem cell transplantation * Has received chemotherapy, any investigational drug, or having participated in another clinical trial within the past 4 weeks prior to trial first drug administration * Has a history of any other significant medical disease * Past or current history (within the last 2 years prior to inclusion) of malignancies except for the indication under this study * Has significant cardiac conduction abnormalities and/or pacemaker * Is a pregnant or nursing female * Has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion * Other significant disease that in the Investigator's opinion would exclude the subject from the trial * Known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s) * Legal incapacity or limited legal capacity
References
Publications (0)
Data not yet available