Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2940680 · 3 trials · 3 indications
DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and meets any one of the following criteria based on NCI CTCAE,version 4.0): Grade(Gr) 3 nonhematological toxicity(tox) with exceptions for made for nausea(ns),vomiting(vm),constipation(cp),diarrhea(dr),fatigue(ft),anorexia(an),alopecia or electrolyte-abnormality(eab) that is manageable with appropriate care.If \>Gr 3 ns,vm,cp,dr,ft,an,or eab persists for\>2 days with maximal supportive intervention,the event was declared a DLT.Transient(≤5 days) Gr 3 liver enzyme elevations,without evidence of other hepatic injury.Gr 3 thrombocytopenia(throm) requiring platelet transfusion or Gr 4 throm.Gr 4 neutropenia of \>5 days duration.Febrile neutropenia(ANC\<1,000/mm3 with a single temperature(temp) of \>38.3 degrees C or a sustained temp of ≥38 degrees C for more than one hour).Tox requiring dose omissions of \>5 days or significant \& deemed by the primary investigator(PI) \& sponsor(sp) to be dose limiting .
The percentage of the total radioactive dose administered that was excreted in feces = \[(amount of radioactivity recovered in feces)/(radioactive dose administered)\]\*100.
The percentage of the total radioactive dose administered that was excreted in urine=\[(amount of radioactivity recovered in urine)/(radioactive dose administered)\]\*100.
Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section.
The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study.
| Arm | Type | Description |
|---|---|---|
| LY2940680 | EXPERIMENTAL | Cohort 1: 100 mg LY2940680 administered orally daily in 28-day cycles. Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles. Cohort 3: 400 mg LY2940680 administered orally daily in 28-day cycles. Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. |
| [^14C]-LY2940680 | EXPERIMENTAL | Single 100 milligram (mg) dose of LY2940680 containing 100 microCuries of carbon-14-labeled LY2940680 (\[\^14C\]-LY2940680) |
| LY2940680 (Part A) | EXPERIMENTAL | Single escalating dose (50 mg up to 400 mg) of LY2940680 given once orally in up to 2 of 2 study periods |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo given once orally in up to 1 of 2 study periods |
| LY2940680 Capsule Fasted (Part B) | EXPERIMENTAL | 100 mg LY2940680 given once orally as a capsule (reference formulation) in fasted state in 1 of 4 study periods |
| LY2940680 Tablet Fasted (Part B) | EXPERIMENTAL | 100 mg LY2940680 given once orally as a tablet (test formulation) in fasted state in 1 of 4 study periods |
| LY2940680 Tablet Fed (Part B) | EXPERIMENTAL | 100 mg LY2940680 given once orally as a tablet (test formulation) in fed state following a standardized, high-fat breakfast in 1 of 4 study periods |
| LY2940680 Tablet Fasted + PPI (Part B) | EXPERIMENTAL | 30 mg lansoprazole (PPI) given orally once daily for 7 days. One hour after last dose, 100 mg LY2940680 given orally once as a tablet (test formulation) in fasted state in 1 of 4 study periods |
| Name | Type | Description |
|---|---|---|
| LY2940680 | DRUG | Administered orally |
| [^14C]-LY2940680 | DRUG | Administered as solution by mouth |
| LY2940680 Capsule(s) (Reference) | DRUG | Administered orally as a capsule(s) |
| LY2940680 Tablet (Test) | DRUG | Administered orally as a tablet |
| Lansoprazole | DRUG | Administered orally as a capsule |
| Placebo Capsule(s) | DRUG | Administered orally as a capsule(s) |
Inclusion Criteria: * Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic. The participant must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to pro...
LY2940680 is an investigational small molecule being studied for use in healthy participants and in patients with advanced cancers, including neoplasm metastasis. It has been evaluated in early-stage clinical trials, though it is not approved and remains in clinical development.
LY2940680 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company has sponsored clinical trials of the drug in the United States and Japan.
LY2940680 is in Phase 1 clinical development. It has completed three Phase 1 trials, including studies in healthy participants and in Japanese participants with advanced cancers. The drug is investigational and has not been approved by regulatory authorities.
LY2940680 has been studied in three completed Phase 1 trials: NCT01681186 and NCT01746745 in healthy participants in the United States, and NCT01919398 in Japanese participants with advanced cancers. These trials are all completed, with no active trials currently listed.
LY2940680 is the primary name used in clinical trial records for this investigational drug. No alternative names have been identified in the available information, so it is not known to be the same as any other marketed or investigational drug.