CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
Galunisertib +2 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • Advanced and/or metastatic cancer refractory to standard therapy or for which gemcitabine would be appropriate (Phase 1b)
  • Histological or cytological diagnosis of pancreatic adenocarcinoma that is locally advanced (Stage II, III) or metastatic (Stage IV) and not amenable to resection with curative intent (Phase 2)
  • Measurable or non-measurable disease per RECIST
  • ECOG performance status ≤2
Key exclusion· 10
  • Moderate or severe cardiac disease including myocardial infarction within 6 months, unstable angina, NYHA Class III/IV CHF, or uncontrolled hypertension
  • Major cardiac abnormalities by echocardiography including moderate/severe valve dysfunction or LVEF <50%
  • Predisposing conditions for aortic aneurysms or aortic stress (e.g., family history of aneurysms, Marfan syndrome, bicuspid aortic valve, imaging evidence of large vessel damage)
  • Unable to swallow tablets or capsules

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

In the news

2 articles

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT01373164
NCT01373164Phase 2Completed

A Phase 1b/2 Study With Gemcitabine and LY2157299 for Patients With Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)

Eli Lilly and Company·interventional·Posted Jun 14, 2011·Updated May 16, 2018

In Brief

A Phase 2 clinical trial evaluating Galunisertib, Gemcitabine, and 1 other intervention for Neoplasms and 2 related conditions. Completed, enrolled 170 participants across 24 sites in 6 countries.

Detailed Summary

Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, Italy, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2011
Enrollment StartJun 1, 2011
Primary CompletionNov 1, 2015
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.0 years ago

Interventions

Galunisertibdrug

Administered orally

Gemcitabinedrug

Administered intravenously

Placebodrug

Administered orally