NCT01668017 is a Phase 1 clinical trial of Pimasertib in Advanced Solid Tumors, sponsored by Merck KGaA, Darmstadt, Germany.

Who is sponsoring NCT01668017?

NCT01668017 is sponsored by Merck KGaA, Darmstadt, Germany.

What drugs are being tested in NCT01668017?

Interventions in NCT01668017: Pimasertib, Pimasertib, Pimasertib, Pimasertib, Pimasertib.

What condition does NCT01668017 study?

NCT01668017 studies Advanced Solid Tumors, Hepatocellular Carcinoma.

Is NCT01668017 still recruiting?

NCT01668017 is currently terminated. Last updated 23 August 2017.

Are results published for NCT01668017?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-23 · How we verify

NCT01668017

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicentre, Open Label, Phase 1 Trial in Japan of the Mitogen Activated Protein Extracellular Signal Regulated Kinase (MEK) Inhibitor Pimasertib Given Orally to Subjects With Solid Tumors as Monotherapy

Terminated Phase 1 Results posted Last updated 23 August 2017

What this trial tests

Phase 1 trial testing Pimasertib in Advanced Solid Tumors in 26 participants. Terminated before completion.

Timeline

30 September 2012

Primary endpoint
31 May 2015

31 May 2015

Quick facts

Lead sponsor	Merck KGaA, Darmstadt, Germany
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	30 September 2012
Primary completion	31 May 2015
Estimated completion	31 May 2015
Sites	1 location across Japan

Drugs / interventions tested

Pimasertib — full drug profile →
Pimasertib — full drug profile →
Pimasertib — full drug profile →
Pimasertib — full drug profile →
Pimasertib — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Merck KGaA, Darmstadt, Germany — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors or Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects Who Experienced at Least One Dose Limiting Toxicity (DLT) Primary · During Treatment Cycle 1 (Day 1 to 21)

DLT defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0): any of following toxicities possibly/probably related to study drug: Any non-hematological toxicity of Grade 3 or higher (excluding Grade 3 asymptomatic rise in liver function tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], alkaline phosphatase \[ALP\], gamma-glutamyl transferase \[GGT\] reversible in 7 days for subjects with solid tumor and without liver involvement, or Grade 4 for subjects with HCC or with liver involvement; Grade 3 or 4 asymptoma

Group	Value	95% CI
Part 1: Pimasertib 30 mg in Solid Tumor	0
Part 1: Pimasertib 45 mg in Solid Tumor	0
Part 1: Pimasertib 60 mg in Solid Tumor	2
Part 1: Pimasertib 30 mg in HCC	1
Part 1: Pimasertib 45 mg in HCC	1

Number of Subjects Who Experienced Treatment-Emergent Adverse Events (TEAEs) or Serious TEAEs Secondary · Baseline up to 30 days post last dose of study drug; assessed maximum up to 39.4 weeks

An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disabi

TEAEs

Group	Value	95% CI
Part 1: Pimasertib 30 mg in Solid Tumor	4
Part 1: Pimasertib 45 mg in Solid Tumor	9
Part 1: Pimasertib 60 mg in Solid Tumor	6
Part 1: Pimasertib 30 mg in HCC	5
Part 1: Pimasertib 45 mg in HCC	2

Serious TEAEs

Group	Value	95% CI
Part 1: Pimasertib 30 mg in Solid Tumor	2
Part 1: Pimasertib 45 mg in Solid Tumor	2
Part 1: Pimasertib 60 mg in Solid Tumor	2
Part 1: Pimasertib 30 mg in HCC	2
Part 1: Pimasertib 45 mg in HCC	0

Maximum Observed Concentration (Cmax) of Pimasertib on Cycle 1 Day 1 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1

Group	Value	95% CI
Part 1: Pimasertib 30 mg in Solid Tumor	162.4	± 113.1
Part 1: Pimasertib 45 mg in Solid Tumor	222.1	± 45.2
Part 1: Pimasertib 60 mg in Solid Tumor	288.3	± 52.1
Part 1: Pimasertib 30 mg in HCC	167.6	± 26.3

Maximum Observed Concentration (Cmax) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1

The summarized data was not available for this arm therefore individual data was presented.

Subject 1

Group	Value	95% CI
Part 1: Pimasertib 45 mg in HCC	225

Subject 2

Group	Value	95% CI
Part 1: Pimasertib 45 mg in HCC	281

Maximum Observed Concentration (Cmax) of Pimasertib on Cycle 1 Day 15 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15

Data were not reported for "Part 1: Pimasertib 45 mg in HCC" arm as there were no PK samples collected for this arm.

Group	Value	95% CI
Part 1: Pimasertib 30 mg in Solid Tumor	199.5	± 58.9
Part 1: Pimasertib 45 mg in Solid Tumor	231.6	± 66.1
Part 1: Pimasertib 60 mg in Solid Tumor	336.3	± 30.8

Maximum Observed Concentration (Cmax) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15

The summarized data was not available for this arm therefore individual data was presented.

Subject 1

Group	Value	95% CI
Part 1: Pimasertib 30 mg in HCC	320

Subject 2

Group	Value	95% CI
Part 1: Pimasertib 30 mg in HCC	419

Time to Reach Maximum Concentration (Tmax) on Cycle 1 Day 1 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1

Group	Value	95% CI
Part 1: Pimasertib 30 mg in Solid Tumor	2.450	0.48 – 4.00
Part 1: Pimasertib 45 mg in Solid Tumor	1.480	0.48 – 7.98
Part 1: Pimasertib 60 mg in Solid Tumor	1.710	0.97 – 2.43
Part 1: Pimasertib 30 mg in HCC	1.000	0.95 – 2.57

Time to Reach Maximum Concentration (Tmax) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1

The summarized data was not available for this arm therefore individual data was presented.

Subject 1

Group	Value	95% CI
Part 1: Pimasertib 45 mg in HCC	1.47

Subject 2

Group	Value	95% CI
Part 1: Pimasertib 45 mg in HCC	1.92

Time to Reach Maximum Concentration (Tmax) on Cycle 1 Day 15 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15

Data were not reported for "Part 1: Pimasertib 45 mg In HCC" arm as there were no PK samples collected for this arm.

Group	Value	95% CI
Part 1: Pimasertib 30 mg in Solid Tumor	1.805	1.00 – 2.48
Part 1: Pimasertib 45 mg in Solid Tumor	1.910	1.00 – 2.48
Part 1: Pimasertib 60 mg in Solid Tumor	2.550	1.50 – 5.88

Time to Reach Maximum Concentration (Tmax) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15

The summarized data was not available for this arm therefore individual data was presented.

Subject 1

Group	Value	95% CI
Part 1: Pimasertib 30 mg in HCC	0.98

Subject 2

Group	Value	95% CI
Part 1: Pimasertib 30 mg in HCC	0.95

Area Under the Concentration Over Time (AUCt) at Cycle 1 Day 1 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1

Group	Value	95% CI
Part 1: Pimasertib 30 mg in Solid Tumor	703.0	± 73.8
Part 1: Pimasertib 45 mg in Solid Tumor	862.4	± 42.8
Part 1: Pimasertib 60 mg in Solid Tumor	1626.9	± 43.6
Part 1: Pimasertib 30 mg in HCC	911.4	± 27.3

Area Under the Concentration Over Time (AUCt) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1 Secondary · Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1

The summarized data was not available for this arm therefore individual data was presented.

Subject 1

Group	Value	95% CI
Part 1: Pimasertib 45 mg in HCC	1754

Subject 2

Group	Value	95% CI
Part 1: Pimasertib 45 mg in HCC	1430

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 30 days post last dose of study drug; assessed maximum up to 39.4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Pimasertib 30 mg in Solid Tumor

Serious: 2/4 (50%)

Deaths: —

Part 1: Pimasertib 45 mg in Solid Tumor

Serious: 2/9 (22%)

Deaths: —

Part 1: Pimasertib 60 mg in Solid Tumor

Serious: 2/6 (33%)

Deaths: —

Part 1: Pimasertib 30 mg in HCC

Serious: 2/5 (40%)

Deaths: —

Part 1: Pimasertib 45 mg in HCC

Serious: 0/2 (0%)

Deaths: —

Serious adverse events (8 terms)

Reaction	System	Part 1: Pimasertib 30 mg i…	Part 1: Pimasertib 45 mg i…	Part 1: Pimasertib 60 mg i…	Part 1: Pimasertib 30 mg i…	Part 1: Pimasertib 45 mg i…
Pyrexia	General disorders	—	—	—	—	—
Disease progression	General disorders	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—
Jaundice cholestatic	Hepatobiliary disorders	—	—	—	—	—
Liver disorder	Hepatobiliary disorders	—	—	—	—	—
Infection	Infections and infestations	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Other adverse events (96 terms — click to expand)

Reaction	System	Part 1: Pimasertib 30 mg i…	Part 1: Pimasertib 45 mg i…	Part 1: Pimasertib 60 mg i…	Part 1: Pimasertib 30 mg i…	Part 1: Pimasertib 45 mg i…
Retinal detachment	Eye disorders	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—
Dermatitis acneiform	Skin and subcutaneous tissue disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—
Retinal haemorrhage	Eye disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—
Localised oedema	General disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Delirium	Psychiatric disorders	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Pericardia effusion	Cardiac disorders	—	—	—	—	—
Visual impairment	Eye disorders	—	—	—	—	—
Macular oedema	Eye disorders	—	—	—	—	—
Ocular hypertension	Eye disorders	—	—	—	—	—
Retinal tear	Eye disorders	—	—	—	—	—
Macular detachment	Eye disorders	—	—	—	—	—
Metamorphopsia	Eye disorders	—	—	—	—	—
Visual acuity reduced	Eye disorders	—	—	—	—	—

Most-reported serious reactions: Pyrexia, Disease progression, General physical health deterioration, Jaundice cholestatic, Liver disorder, Infection, Muscular weakness, Pulmonary haemorrhage.

Data from ClinicalTrials.gov NCT01668017 adverse events section.

Sponsor's own description

This is a two-part trial. "Solid tumor" in this protocol means solid tumor excluding hepatocellular carcinoma (HCC). Part 1: Dose Escalation Phase in subjects with solid tumor (Cohort A) and HCC (Cohort B). The dose will be increased from 45 mg twice a day (BID) with 3+3 cohort method up to the recommended phase 2 dose (RP2D) of pimasertib established as single agent in the global studies for each arm independently. Part 2: The Maximum Tolerated Dose (MTD) defined in Part 1 will be confirmed in more subjects in Cohort A (N=18) and Cohort B (N=6) separately. Following the recommendation by the Safety Monitoring Committee, Cohort B was discontinued due to hepatocellular carcinoma (HCC) and there will be no further enrollment of subjects to this cohort. This decision is based upon review of safety and efficacy information.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Harnessing the immune system against cancer: current immunotherapy approaches and therapeutic targets.
Kumar AR, Devan AR, Nair B, Vinod BS, et al · · 2021 · cited 98× · PMID 34671902 · DOI 10.1007/s11033-021-06752-9
Natural products targeting the MAPK-signaling pathway in cancer: overview.
Shi A, Liu L, Li S, Qi B. · · 2024 · cited 40× · PMID 38193944 · DOI 10.1007/s00432-023-05572-7
New targeted therapies in pancreatic cancer.
Seicean A, Petrusel L, Seicean R. · · 2015 · cited 38× · PMID 26034349 · DOI 10.3748/wjg.v21.i20.6127
New landscapes and horizons in hepatocellular carcinoma therapy.
Cervello M, Emma MR, Augello G, Cusimano A, et al · · 2020 · cited 37× · PMID 32018226 · DOI 10.18632/aging.102777

Verify or expand the search:

Other trials of Pimasertib

Trials testing the same drug.

NCT04789668 — Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases · Phase 1, PHASE2 · terminated
NCT01693068 — Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma · Phase 2 · completed
NCT01713036 — Oral Bioavailability and Mass Balance Trial With Pimasertib · Phase 1 · completed
NCT01378377 — Combination Trial of Pimasertib (MSC1936369B) With Temsirolimus · Phase 1 · terminated
NCT01016483 — Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer · Phase 1, PHASE2 · completed

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other Merck KGaA, Darmstadt, Germany trials

Trials by the same sponsor.

NCT03845140 — L-PZQ ODT in Schistosoma Infected Children · Phase 3 · completed
NCT03858049 — Efficacy and Safety of Crinone Versus Combination Medication (ACCESS) · Phase 4 · terminated
NCT03745144 — Effects of Cladribine Tablets on the PK of Microgynon® · Phase 1 · completed
NCT03717155 — Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC · Phase 2 · completed
NCT03725072 — Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01668017 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck KGaA, Darmstadt, Germany
Last refreshed: 23 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01668017.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01668017

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (8 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Pimasertib

Other recruiting trials for Advanced Solid Tumors

Other Merck KGaA, Darmstadt, Germany trials

Verify against primary sources