Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pimasertib · 1 trial · 1 indication
DLT using the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE) v3.0,was defined as any of the following toxicities at any dose level and judged to be possibly or probably related to trial medication by the Investigator and/or the Sponsor and relevant for the combination treatment: Grade 3/more non-hematological toxicity excluding: Subjects with liver involvement: Grade 4 asymptomatic increases in liver function tests and subject without liver involvement: Grade 3 asymptomatic increases in liver function tests reversible within 7 days. Grade 3 vomiting encountered despite adequate therapy. Grade 3 diarrhea encountered despite adequate anti diarrhea therapy. Grade 4 neutropenia greater (\>) 5 days duration or febrile neutropenia lasting for more than 1 day. Grade 4 thrombocytopenia \> 1 day/Grade 3 with bleeding. Grade 4 anemia: Any treatment delay \> 2 weeks due to drug-related adverse effects.
PFS was defined as the time from randomization to the first documentation of objective tumor progression (Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline, Progressive Disease (PD): At least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started) or to death due to any cause, whichever occurred first. PFS calculated as (Months) = Date of first PD or death or censoring date minus date of randomization plus 1) divided by 30.4375.
| Arm | Type | Description |
|---|---|---|
| Safety Run-in Part: Regimen 1 | EXPERIMENTAL | Subjects will receive pimasertib capsule orally once daily (qd) doses of 15, 30, 45, 68, 90, and 120 milligram (mg) on Day 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15,16, 17, 18, 19, 22, 23, 24, 25, 26 and gemcitabine 1000 milligram per square meter (mg/m\^2) intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks). |
| Safety Run-in Part: Regimen 2 | EXPERIMENTAL | Subjects will receive pimasertib capsule orally twice daily (bid) doses of 60 and 75 mg continuously for a 28-day cycle and gemcitabine 1000 mg/m\^2 intravenous (IV) infusion for 30 minutes on Days 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (1 Cycle = 8 weeks) (bid - continuous regimen). |
| Phase II: Arm 1 (Gemcitabine + Placebo) | ACTIVE_COMPARATOR | Subjects will receive gemcitabine 1000 mg/m\^2 IV infusion on for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and placebo matched to pimasertib orally bid - continuous regimen. |
| Phase II: Arm 2 (Gemcitabine + Pimasertib) | EXPERIMENTAL | Subjects will receive gemcitabine 1000 mg/m\^2 IV infusion for 30 minutes on Day 1, 8, 15, 22, 29, 36, and 43 followed by a 1-week rest (Cycle 1) then on Days 1, 8, and 15 of a 28-day cycle and pimasertib capsule orally bid - continuous regimen. |
| Name | Type | Description |
|---|---|---|
| Pimasertib | DRUG | - |
| Gemcitabine | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Subject has provided signed informed consent. Fully understands requirements of the trial and willing to comply with all trial visits and assessments. 2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas and availability of tumor sample. 3. E...
Pimasertib is an investigational small molecule being studied for the treatment of Pancreatic Adenocarcinoma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated in combination with gemcitabine to assess its safety and efficacy in patients with this type of cancer.
Pimasertib is a small molecule that targets the MEK pathway, which is involved in cell growth and survival. By inhibiting this pathway, the drug aims to slow or stop the growth of cancer cells. This mechanism is being explored in the context of Pancreatic Adenocarcinoma, where abnormal MEK signaling can contribute to tumor progression.
Pimasertib is being developed by Merck KGaA, a multinational pharmaceutical company. The company's stock is traded under the ticker symbol MKGAF. Merck KGaA is conducting clinical trials to evaluate the drug's potential as a treatment for Pancreatic Adenocarcinoma.
Pimasertib is currently in Phase 1 clinical development. This means it is in the early stages of testing in humans, primarily to evaluate safety, tolerability, and dosing. The drug is not yet approved by the FDA or any other regulatory body and remains investigational. One Phase 1 trial has been completed.
Pimasertib has been studied in one clinical trial with the identifier NCT01016483. This Phase 1 trial, titled 'Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer,' enrolled 141 participants with Pancreatic Adenocarcinoma. The study was completed and included sites in the United States and Germany.
Yes, Pimasertib is also known as MSC1936369B. In clinical trials, the drug has been referred to by this alternative name. For example, the Phase 1 trial NCT01016483 used the name MSC1936369B when describing the investigational treatment being tested in combination with gemcitabine.