What side effects are associated with this type of intervention?

Common treatments for endometrial cancer include pelvic radiation therapy (RT), vaginal brachytherapy (VBT) followed by chemotherapy (paclitaxel/carboplatin), and targeted therapies like LY2880070. Pelvic RT is associated with fatigue, which typically recovers to pretreatment levels within 11 weeks, and late toxicity comparable to other treatments. VBT followed by chemotherapy can cause greater acute toxicity, more serious adverse events, including neurotoxicity, and higher rates of nodal recurrences. Targeted therapies like LY2880070, which focus on tumor growth and progression, may have side effects such as fatigue, gastrointestinal issues, and potential liver function abnormalities, although specific side effects for LY2880070 are not detailed in the context.

What prior FDA approvals exist?

FDA-approved treatments for endometrial cancer that are similar to LY2880070, a targeted therapy, include pembrolizumab, which targets PD-L1 expression in tumors. Pembrolizumab is used for patients whose tumors express PD-L1 and have progressed on prior chemotherapy. Additionally, everolimus, an mTOR inhibitor, has shown efficacy when combined with letrozole in hormone receptor-positive endometrial cancer, achieving a response rate of up to 32 percent. These treatments focus on inhibiting specific pathways involved in tumor growth and progression, similar to the approach of LY2880070.

What other types of research exist?

Promising alternatives to LY2880070 for endometrial cancer patients include the combination of lenvatinib and pembrolizumab, which has shown superiority in progression-free survival and overall survival in patients with advanced endometrial cancer after platinum-based therapy. Additionally, PARP inhibitors and angiogenesis inhibitors like bevacizumab are also being explored as potential treatments.

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Other

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

Must not have

Have symptomatic central nervous system (CNS) metastasis

Females who are pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to study completion (estimated up to 4 years)

Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain and is causing symptoms.

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I am not pregnant or nursing.

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I have undergone a bone marrow transplant.

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I have received radiation therapy to more than a quarter of my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to study completion (estimated up to 4 years)

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