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Topoisomerase I inhibitor

EP0057 + Olaparib for Small Cell Lung Cancer

Phase 1 & 2
Recruiting
Led By Anish Thomas, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase II SCLC: Age >=18 years. Patients must have histologically or cytologically confirmed diagnosis of SCLC from a CLIA-certified laboratory. Have received and progressed during or after a platinum-based standard chemotherapy regimen and/or an immune-checkpoint inhibitor. Patients must have measurable disease as per RECIST 1.1. Radiographic evidence of disease progression after initial therapy should have been documented. ECOG performance status <=2. Patients with treated brain metastases are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients must have normal organ and marrow function as defined. Women of child-bearing potential and men must agree to use highly effective contraception. Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of olaparib. Ability to understand and the willingness to sign a written informed consent document.
Urothelial Carcinoma Expansion Cohort: Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis from a CLIA-certified laboratory, with measurable disease by RECIST (version 1.1) including lymphadenopathy and visceral metastatic disease. Male or female patients >= 18 years of age. Patient must have received at least one platinum based regimen of chemotherapy and/or an immune-checkpoint inhibitor if appropriate with progressive disease. ECOG 0 2. Patients must have normal organ and marrow function as defined. Women of child-bearing potential and men must agree to use highly effective contraception. Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of olaparib. Ability to understand and the willingness to sign a written informed consent document. Willingness to release archival tissue sample for research purposes, if available.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3 months post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of a new drug combination to treat small cell lung cancer.

Who is the study for?
Adults over 18 with small cell lung cancer that's gotten worse after treatment can join this trial. They need to have stable health, including normal organ and marrow function, and be off or on a steady dose of steroids if they've had brain metastases. Women who can get pregnant and men must use birth control.
What is being tested?
Researchers are testing EP0057, a new drug made from sugar and chemotherapy linked together, given through an IV every two weeks. Olaparib is another drug taken orally twice daily that may stop cancer cells from fixing DNA damage caused by chemo.
What are the potential side effects?
Possible side effects include reactions where the drugs enter the body, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, hair loss (except alopecia), nerve pain (neuropathy), and potential for severe lung inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Criterion: You are over 18 years old and have been diagnosed with small cell lung cancer. You have already tried standard chemotherapy or immune-checkpoint inhibitor treatment and your disease has continued to progress. You have evidence of measurable disease and are in a condition where you can take oral medications. You must also meet specific organ and marrow function requirements, and agree to use contraception if capable of having children. Additionally, you must be able to understand and sign a consent form.
Select...
Criterion: You have been diagnosed with urothelial carcinoma, a type of bladder or urinary tract cancer, and have measurable disease. You are at least 18 years old and have received a certain type of chemotherapy or immune-checkpoint inhibitor with no improvement in your condition. You should be in good overall health and able to take oral medication. If you can have children, you must use effective birth control. You need to understand and agree to take part in the study, and be willing to provide a tissue sample for research.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Expansion: Determine the PFS rate in the combination of olaparib plus EP0057 at 16 weeks in SCLC patients.
Expansion: To determine overall response rate of EP0057 plus olaparib in patients with mCRPC
Expansion: To determine overall response rate of EP0057 plus olaparib in patients with urothelial carcinoma
+1 more
Secondary study objectives
Determine the duration of response (DOR), overall survival (OS), and progression-free survival (PFS) of the combination
Evaluate the pharmacodynamic (PD) activity of EP0057 in blood, surrogate tissue and tumor biopsy specimens.
Evaluate the pharmacokinetic profile of EP0057 (both the total drug and released camptothecin) and olaparib in plasma
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Phase IIExperimental Treatment2 Interventions
EP0057 + olaparib at MTD/RP2D
Group II: 1/Phase IExperimental Treatment2 Interventions
EP0057 + olaparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
olaparib
2009
Completed Phase 3
~990
EP0057
2020
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,329 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
780 Total Patients Enrolled

Media Library

EP0057 (Topoisomerase I inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02769962 — Phase 1 & 2
Lung Cancer Research Study Groups: 2/Phase II, 1/Phase I
Lung Cancer Clinical Trial 2023: EP0057 Highlights & Side Effects. Trial Name: NCT02769962 — Phase 1 & 2
EP0057 (Topoisomerase I inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02769962 — Phase 1 & 2
~9 spots leftby Jul 2025
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