CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
LY3295668drug
Likely dose
Not stated in record
Key inclusion· 10
  • ✓1–4 prior systemic therapies
  • ✓ECOG performance status 0 or 1
  • ✓Adequate organ function
  • ✓Life expectancy ≥12 weeks
Key exclusion· 8
  • ✕Symptomatic CNS metastasis
  • ✕Primary CNS tumor
  • ✕Swallowing disorder or GI disease precluding participation
  • ✕Uncontrolled electrolyte abnormalities (hypokalemia, hypomagnesemia, hypocalcemia)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03092934
NCT03092934Phase 2Completed
CompareCT.gov

A Phase I/II Open-Label Multicenter Study to Evaluate the Safety and Efficacy of AK-01 as Monotherapy in Patients With Locally Advanced or Metastatic Solid Tumors

Eli Lilly and Company·interventional·Posted Mar 28, 2017·Updated Jul 2, 2021

In Brief

A Phase 2 clinical trial evaluating LY3295668 for Neoplasms and 6 related conditions. Completed, enrolled 13 participants across 3 sites.

Detailed Summary

This two-part study consists of a phase 1 dose escalation study in participants with locally advanced or metastatic solid tumors, and a phase 2 portion in up to 3 groups with either small cell lung cancer, breast cancer and/or one other solid tumor type.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Neoplasm Metastasis, Triple Negative Breast Neoplasms, Head and Neck Neoplasms, Breast Neoplasms, Solid Tumor, Adult, Small Cell Lung Carcinoma
CountriesCanada
CollaboratorsAurKa Pharma Inc.

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 28, 2017
Enrollment StartMay 29, 2017
Primary CompletionApr 20, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.3 years ago

Interventions

LY3295668drug

Oral capsules