Part A: LY2880070 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Centre Hospitalier de l'Université de Montréal, Montréal, CanadaBreast Cancer+10 MoreGemcitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trialis testing a drug for people with advanced cancer to see if it's safe and effective.

Eligible Conditions
  • Breast Cancer
  • Colon Cancer
  • Tumors
  • Soft Tissue Sarcoma
  • Pancreatic Cancer
  • Solid Tumors
  • Colorectal Cancer
  • Ovarian Cancer
  • Endometrial Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Baseline to study completion (estimated up to 4 years)

Day 21
Maximum Tolerated Dose(s)
Number of dose limiting toxicities (DLTs)
Day 20
Change from baseline in lymphocyte count
Change from baseline in neutrophil count
Change from baseline in white blood cell count
Time to reach maximum plasma concentration (tmax)
Day 20
Peak plasma concentration (Cmax)
Day 20
Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24)
Year 4
Best response
Duration of objective response
Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1)
Progression free survival
Year 1
Overall survival

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

10 Treatment Groups

Part A: LY2880070
1 of 10
Part A: LY2880070 with Gemcitabine
1 of 10
Part B:LY2880070 and Gemcitabine (Ovarian)
1 of 10
Part B: LY2880070 and Gemcitabine (Endometrial)
1 of 10
Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))
1 of 10
Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer)
1 of 10
Part A: LY2880070 (Metabolism Phenotype)
1 of 10
Part B: LY2880070 and Gemcitabine (Colorectal)
1 of 10
Part B: LY2880070 and Gemcitabine (Pancreatic)
1 of 10
Part B: LY2880070 and Gemcitabine (Breast)
1 of 10

Experimental Treatment

229 Total Participants · 10 Treatment Groups

Primary Treatment: Part A: LY2880070 · No Placebo Group · Phase 1 & 2

Part A: LY2880070
Drug
Experimental Group · 1 Intervention: LY2880070 · Intervention Types: Drug
Part A: LY2880070 with GemcitabineExperimental Group · 2 Interventions: Gemcitabine, LY2880070 · Intervention Types: Drug, Drug
Part B:LY2880070 and Gemcitabine (Ovarian)Experimental Group · 2 Interventions: Gemcitabine, LY2880070 · Intervention Types: Drug, Drug
Part B: LY2880070 and Gemcitabine (Endometrial)Experimental Group · 2 Interventions: Gemcitabine, LY2880070 · Intervention Types: Drug, Drug
Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))Experimental Group · 2 Interventions: Gemcitabine, LY2880070 · Intervention Types: Drug, Drug
Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer)Experimental Group · 2 Interventions: Gemcitabine, LY2880070 · Intervention Types: Drug, Drug
Part A: LY2880070 (Metabolism Phenotype)
Drug
Experimental Group · 1 Intervention: LY2880070 · Intervention Types: Drug
Part B: LY2880070 and Gemcitabine (Colorectal)Experimental Group · 2 Interventions: Gemcitabine, LY2880070 · Intervention Types: Drug, Drug
Part B: LY2880070 and Gemcitabine (Pancreatic)Experimental Group · 2 Interventions: Gemcitabine, LY2880070 · Intervention Types: Drug, Drug
Part B: LY2880070 and Gemcitabine (Breast)Experimental Group · 2 Interventions: Gemcitabine, LY2880070 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to study completion (estimated up to 4 years)

Who is running the clinical trial?

Esperas Pharma Inc.Lead Sponsor
Email: choruspharma@lists.lilly.comStudy DirectorEsperas Pharma Inc.

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Are there multiple venues in Canada where this research project is being conducted?

"This ongoing medical trial is available at 9 locations, including Montreal, Edmonton and Detroit. It would be prudent to choose the nearest study site so as to limit your transportation burden should you decide to join." - Anonymous Online Contributor

Unverified Answer

Does this experiment still accept volunteers?

"That is correct. According to clinicaltrials.gov, the trial which was originally posted on May 16th 2016 has recently resumed recruiting efforts and seeks 229 patients from 9 different locations." - Anonymous Online Contributor

Unverified Answer

To which maladies is Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)) commonly deployed?

"Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)) are indicated for use in small cell lung cancer treatment, but may also be useful to treat other carcinomas such as head and neck cancers, pancreatic adenocarcinoma locally advanced, or cervical tumours." - Anonymous Online Contributor

Unverified Answer

What is the maximum capacity for enrollment in this research project?

"Correct. According to clinicaltrials.gov, this study has been recruiting since May 16th 2016 and was last updated on January 11th 2023. The protocol requires the enrolment of 229 participants from 9 different medical sites." - Anonymous Online Contributor

Unverified Answer

Are there any other research projects that have tested the efficacy of Part B: LY2880070 and Gemcitabine when treating Soft Tissue Sarcoma (STS)?

"Currently, 416 trials assessing the efficacy of Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)) are in progress with 127 at Phase 3. While Adelaide, South Australia has the most studies devoted to this research endeavor, there remain 23323 clinical trial sites around the world investigating Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.