Clinical trial · Interventional
Relative Bioavailability of Pimasertib in Cancer Patients
A Multi-Center, Open-Label, Single 60 mg Dose, Two Period, Two Sequence Cross-Over Trial to Investigate the Relative Bioavailability of Two Solid Oral Pimasertib Formulations in Cancer Patients
NCT01992874CI-TRIAL-00029069completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a Phase 1, multi-center, open-label, single-dose, 2 period, 2 sequence cross-over trial to investigate the relative bioavailability of 2 solid oral pimasertib formulations in cancer subjects (Part A), followed by open-label pimasertib administration (Part B and trial extension phase).
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pimasertib Capsule (Part A) | Drug | — | UNRESOLVED |
| Pimasertib Capsule (Part B and trial extension phase) | Drug | — | UNRESOLVED |
| Pimasertib Tablet (Part A) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pimasertib Capsule/Pimasertib Tablet
- interventionNames
- Drug: Pimasertib Capsule (Part A)
- Drug: Pimasertib Tablet (Part A)
- Drug: Pimasertib Capsule (Part B and trial extension phase)
- type
- EXPERIMENTAL
- label
- Pimasertib Tablet/Pimasertib Capsule
- interventionNames
- Drug: Pimasertib Tablet (Part A)
- Drug: Pimasertib Capsule (Part A)
- Drug: Pimasertib Capsule (Part B and trial extension phase)
Primary outcomes (2)
- measure
- Maximum Observed Plasma Concentration (Cmax)
- timeFrame
- Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed solid tumors, either refractory to standard therapy or for which no effective standard therapy is available, with a measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * An Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\<=) 1 * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Disease conditions or concomitant medication that may significantly influence the conduct of the trial or an abnormal electrocardiogram (ECG) or blood pressure at Screening as defined in the protocol * Treatment with strong inhibitors or inducers of cytochrome P450 2C19 (CYP2C19) and CYP3A4 including fruit juices or beverages containing these substances * History of prior mitogen-activated protein kinase/extracellular signal-regulated kinase (MAPK/ERK) kinase (MEK) inhibitor exposure (including, pimasertib) or progression of disease on MEK inhibitors * Evidence of a retinal vein occlusion (RVO) on fluorescein angiogram or a history of RVO * Life expectancy of less than 12 weeks * Other protocol defined exclusion criteria could apply
References
Publications (1)
- RESULTMahadevan D, Mita M, Richards D, McClay E, Heist RS, Kumar A, Sundararajan S, Naing A. Phase I single dose, two-period and two-sequence cross-over trial to evaluate the relative bioavailability of two oral pimasertib formulations in advanced cancer patients. Cancer Chemother Pharmacol. 2017 Apr;79(4):681-688. doi: 10.1007/s00280-017-3258-0. Epub 2017 Mar 13. PMID 28289865