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Also known as LY2940680 Capsule(s) (Reference), [^14C]-LY2940680, Taladegib
LY2940680 · 2 trials · 2 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 .
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest tested dose that had \<33% probability of causing a DLT in Cycle 1 of Part A.
| 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. |
| Taladegib | EXPERIMENTAL | Part A Cohort 1: 50 milligram (mg) taladegib administered orally QD on a 28-day cycle. Part A Cohort 2: 100 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 3: 200 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 4: 400 mg taladegib administered orally QD on a 28-day cycle. Part A Cohort 5: 600 mg taladegib administered orally QD on a 28-day cycle. Part C: 400 mg taladegib administered orally QD. Participants with advanced solid tumors. Part D: 400 mg taladegib administered orally QD. Participants with advanced basal cell carcinoma (BCC). |
| Name | Type | Description |
|---|---|---|
| LY2940680 | DRUG | Administered orally |
| Taladegib | DRUG | Administered IV |
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 developed by Eli Lilly and Company for the treatment of neoplasm metastasis, meaning cancer that has spread to other parts of the body. It is in Phase 1 clinical development and has been studied in Japanese participants with advanced cancers.
LY2940680 is being studied for neoplasm metastasis, which is cancer that has spread from its original site to other parts of the body. The only completed trial enrolled Japanese participants with advanced cancers. It is investigational and has not been established as a treatment for any condition.
LY2940680 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the drug in Japanese participants with advanced cancers.
LY2940680 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. Because it remains investigational, LY2940680 is not an approved therapy for neoplasm metastasis or any other indication.
LY2940680 has been evaluated in one completed Phase 1 trial, NCT01919398, titled A Study of LY2940680 in Japanese Participants With Advanced Cancers. The trial enrolled 19 participants in Japan, included adults aged 20 years and older of any sex, and was uncontrolled without randomization or blinding.
LY2940680 is also referred to as LY2940680 Capsule(s) (Reference) and [^14C]-LY2940680. The [^14C] label denotes a carbon-14 radiolabeled version used in study work, while the capsule reference name describes the oral capsule form of the same investigational compound.