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LY2880070 for Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Esperas Pharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
For Part A: Must have evidence of cancer (solid tumors, excluding glioblastoma and primary brain tumor) that is advanced or metastatic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to study completion (estimated up to 4 years)
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for adults with certain advanced or metastatic cancers, including colorectal, breast, ovarian, endometrial cancer and sarcomas. Participants must have measurable tumor lesions and adequate organ function. They should not benefit from standard therapy and agree to use contraception. Exclusions include recent investigational drug use, significant radiation exposure to bone marrow, active secondary cancers within a year (with some exceptions), pregnancy or nursing women, CNS metastasis symptoms, certain viral infections or heart rhythm issues.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of LY2880070 in combination with Gemcitabine for treating various solid tumors. It's divided into three parts: one focusing on metabolism phenotype related to CYP2D6 enzyme activity; another on specific genetic signatures in high-grade serous ovarian cancer; and the third part assessing broader efficacy across multiple cancer types.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site with Gemcitabine such as swelling or pain, flu-like symptoms (fever, headache), nausea/vomiting, low blood cell counts increasing infection risk or bleeding problems. LY2880070 could cause similar effects due to its nature as an experimental cancer treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is advanced or has spread to other parts of my body, excluding brain cancer.
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I am a poor metabolizer according to the CYP2D6 test.
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I have advanced cancer in the colon, breast (triple negative), ovary, uterus, soft tissue, or pancreas.
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My breast cancer is triple negative and has come back or not responded to treatment.
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My endometrial cancer is advanced and didn't respond to at least one chemotherapy.
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My pancreatic cancer is advanced and has not responded to at least one chemotherapy treatment.
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I have had 1-4 treatments for my advanced or spread cancer.
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My colorectal cancer is confirmed to be advanced or has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to study completion (estimated up to 4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study completion (estimated up to 4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose(s)
Secondary outcome measures
Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24)
Best response
Change from baseline in lymphocyte count
+9 more

Trial Design

10Treatment groups
Experimental Treatment
Group I: Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer)Experimental Treatment2 Interventions
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Group II: Part B:LY2880070 and Gemcitabine (Ovarian)Experimental Treatment2 Interventions
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Group III: Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))Experimental Treatment2 Interventions
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Group IV: Part B: LY2880070 and Gemcitabine (Pancreatic)Experimental Treatment2 Interventions
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Group V: Part B: LY2880070 and Gemcitabine (Endometrial)Experimental Treatment2 Interventions
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Group VI: Part B: LY2880070 and Gemcitabine (Colorectal)Experimental Treatment2 Interventions
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Group VII: Part B: LY2880070 and Gemcitabine (Breast)Experimental Treatment2 Interventions
Multiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
Group VIII: Part A: LY2880070 with GemcitabineExperimental Treatment2 Interventions
Multiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles
Group IX: Part A: LY2880070 (Metabolism Phenotype)Experimental Treatment1 Intervention
Multiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers
Group X: Part A: LY2880070Experimental Treatment1 Intervention
Multiple oral doses of LY2880070 during 21-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

Esperas Pharma Inc.Lead Sponsor
Email: Darcy.Vincett@ozmosisresearch.caStudy DirectorEsperas Pharma Inc.
Email: choruspharma@lists.lilly.comStudy DirectorEsperas Pharma Inc.

Media Library

Gemcitabine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02632448 — Phase 1 & 2
Endometrial Cancer Research Study Groups: Part A: LY2880070 with Gemcitabine, Part B:LY2880070 and Gemcitabine (Ovarian), Part B: LY2880070 and Gemcitabine (Endometrial), Part A: LY2880070, Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS)), Part C: LY2880070 and Gemcitabine (High Grade Serous Ovarian Cancer), Part A: LY2880070 (Metabolism Phenotype), Part B: LY2880070 and Gemcitabine (Colorectal), Part B: LY2880070 and Gemcitabine (Pancreatic), Part B: LY2880070 and Gemcitabine (Breast)
Endometrial Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT02632448 — Phase 1 & 2
Gemcitabine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02632448 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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))."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
2016. "A Study of LY2880070 in Participants With Advanced or Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02632448.
All > Metastatic Triple Negative Breast Cancer > Endometrial Cancer
~35 spots leftby Sep 2025
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