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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months post-treatment
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 moreSecondary 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 moreTrial 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
~690
EP0057
2020
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,667 Previous Clinical Trials
40,926,009 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
689 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot be receiving any other experimental medications. If you have experienced significant side effects from previous cancer treatment, except for hair loss and nerve-related issues, you may not participate. If you have been treated with olaparib or similar drugs (for UC expansion Cohort only), you are not eligible. Additionally, if you have certain blood disorders or severe allergic reactions to the study treatments, you cannot take part.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.Criterion: You have advanced prostate cancer that has spread, and have already been treated with certain medications. You must have low levels of testosterone, and be in good overall health. You must also agree to certain medical procedures and use contraception if applicable.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.
Research Study Groups:
This trial has the following groups:- Group 1: 2/Phase II
- Group 2: 1/Phase I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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