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Topoisomerase I inhibitor

EP0057 + Olaparib for Small Cell Lung Cancer

National Institutes of Health Clinical Center, Bethesda, MD
Targeting 5 different conditionsolaparib +1 morePhase 1 & 2RecruitingLed by Anish Thomas, M.D.Research Sponsored by National Cancer Institute (NCI)

Study Summary

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

Eligible Conditions
  • Lung Cancer
  • Bladder Cancer
  • Small Cell Lung Cancer
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You don't necessarily need to have a measurable disease to participate in Phase I.
You agree to provide a tissue sample from a previous medical procedure for research purposes, if it is available.
You have had tumors in your brain that were treated with surgery or radiation, but they must have been stable for at least 2 weeks and you should not be taking certain medications that could interact with the study drug.


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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
Completed Phase 2

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,486 Previous Clinical Trials
41,267,040 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
676 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

Frequently Asked Questions

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

What medical condition is EP0057 commonly used to treat?

"EP0057 has been clinically tested to treat advance directives, ovarian cancer, and primary peritoneal cancer."

Answered by AI

Is this a cutting-edge research project?

"Since 2005, EP0057 has been the focus of numerous clinical trials. The initial trial was sponsored by AstraZeneca and included 98 participants - leading to its Phase 1 drug approval. Currently there are 188 active studies for this medicine occurring in 59 countries across 1468 cities."

Answered by AI

Has EP0057 been the subject of prior scientific inquiry?

"Presently, 188 clinical trials are being conducted in order to research EP0057. Out of those studies, 27 have advanced past the third phase. Despite most of these trials taking place near Houston, Texas, there are 9250 different sites around the world that provide access to this medical treatment."

Answered by AI

How many participants are the maximum allowed to join this experiment?

"Absolutely. Data hosted on clinicaltrials.gov attests to the fact that this medical study is still searching for participants, having been initially posted on May 9th 2016 and recently modified in November 16th 2022. 123 patients from a single trial site are needed to complete the trail."

Answered by AI

What is the primary aim of this research endeavor?

"This 28-day medical trial will assess the overall response rate of EP0057 plus olaparib in patients with urothelial carcinoma. Secondary objectives include exploring further safety combination effects, determining duration of response and PSA on mCRPC expansion cohort, and noting any adverse event frequency associated with the study regimen."

Answered by AI

Are there any vacancies remaining for potential participants of this study?

"Affirmative. Information housed on clinicaltrials.gov reveals that this medical research is presently seeking participants, with the initial post date being May 9th 2016 and latest update occurring November 16th 2022. The team requires 123 subjects from a solitary site to join in the trial."

Answered by AI
~21 spots leftby Jul 2025