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DNA Repair Inhibitor
AsiDNA + Olaparib for Recurrent Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Onxeo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
iv. Surgically (bilateral orchiectomy) or medically castrated, with serum testosterone 50 ng/dL (≤1.73 nmol/L) at screening
iii. Progressive disease in the setting of medical or surgical castration (ie, CRPC) by PCWG3 criteria for study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights
Study Summary
This trial tests a new drug combo to treat ovarian, breast and prostate cancer that has worsened despite PARP inhibitor therapy. Researchers will look at how safe and effective it is.
Who is the study for?
Adults with recurrent ovarian, breast, or prostate cancer that's worsened after treatment or who can't tolerate standard treatments. They must have tried PARP inhibitors before and for prostate cancer, be medically castrated. Breast cancer patients need known ER/PR/HER2 status; HER2 positive and those without prior sacituzumab aren't eligible.Check my eligibility
What is being tested?
The trial is testing AsiDNA combined with Olaparib in people with certain types of recurring cancers to see if it's safe and works against tumors. It has two parts: Phase 1b finds the right dose and Phase 2 tests its effectiveness at that dose.See study design
What are the potential side effects?
Potential side effects include issues from taking oral medication, reactions related to drug metabolism by the liver (CYP3A interactions), worsening of previous persistent cancer therapy side effects except hair loss, and complications from brain metastases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have undergone treatment to lower my testosterone levels below 50 ng/dL.
Select...
My prostate cancer has worsened despite treatment to lower testosterone.
Select...
My cancer has spread to other parts of my body, as shown by scans.
Select...
My prostate cancer is confirmed to be advanced and resistant to hormonal therapy.
Select...
My prostate cancer has spread and is visible on scans.
Select...
My ER+ tumor has worsened despite previous treatments with CDK4/6 inhibitors.
Select...
My cancer's ER, PR, and HER2 status are documented according to ASCOCAP criteria.
Select...
My breast cancer has come back and was confirmed by a lab test.
Select...
I am a woman with a specific type of ovarian, fallopian tube, or peritoneal cancer that has come back.
Select...
I am willing to continue hormone therapy for prostate cancer during the study.
Select...
My advanced cancer (ovarian, breast, prostate) has worsened after all known beneficial treatments.
Select...
My cancer is not HER2 positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: Evaluate the safety and tolerability and determine the recommended Phase 2 dose (RP2D) of AsiDNA administered in combination with olaparib in participants with advanced and/or metastatic ovarian, breast, or prostate cancer.
Phase 2: Evaluate the anti-tumor activity of AsiDNA in combination with olaparib.
Secondary outcome measures
Phase 1b: Assess the pharmacokinetics (PK) of AsiDNA when administered in combination with olaparib in participants with advanced and/or metastatic ovarian, breast, or prostate cancer.
Phase 2: Evaluate additional parameters of efficacy of AsiDNA in combination with olaparib.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose Expansion: Recurrent Epithelial Ovarian Cancer CohortExperimental Treatment2 Interventions
Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
Group II: Dose Expansion: Recurrent Breast Cancer CohortExperimental Treatment2 Interventions
Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
Group III: Dose Expansion: Metastatic Castration-resistant Prostate Cancer CohortExperimental Treatment2 Interventions
Recommended Phase 2 dose of AsiDNA delivered intravenously weekly in combination with Olaparib
Group IV: Dose EscalationExperimental Treatment2 Interventions
Three dose levels of AsiDNA delivered intravenously weekly in combination with Olaparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AsiDNA
2018
Completed Phase 1
~40
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
OnxeoLead Sponsor
27 Previous Clinical Trials
3,798 Total Patients Enrolled
Valerio TherapeuticsLead Sponsor
28 Previous Clinical Trials
3,963 Total Patients Enrolled
1 Trials studying Breast Cancer
165 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone treatment to lower my testosterone levels below 50 ng/dL.I have stopped taking certain strong medications for the required time before starting olaparib.My prostate cancer has worsened despite treatment to lower testosterone.I have breast cancer.My cancer has spread to other parts of my body, as shown by scans.My prostate cancer is confirmed to be advanced and resistant to hormonal therapy.My prostate cancer has spread and is visible on scans.I have triple-negative breast cancer and have been treated with sacituzumab before.My ER+ tumor has worsened despite previous treatments with CDK4/6 inhibitors.My cancer's ER, PR, and HER2 status are documented according to ASCOCAP criteria.My breast cancer has come back and was confirmed by a lab test.I have lasting side effects from cancer treatment, but not hair loss.I am 18 years old or older.I am a woman with a specific type of ovarian, fallopian tube, or peritoneal cancer that has come back.I am not currently using strong or moderate drugs that affect liver enzymes.I haven't had major radiation therapy in the last 4 weeks or bone-targeted radiation in the last 2 weeks.I have prostate cancer.It has been over 6 months since my last platinum-based chemotherapy.I am willing to continue hormone therapy for prostate cancer during the study.I have ovarian cancer.I haven't taken any cancer drugs in the last 28 days, except for PARPi.I haven't had cancer in the last 5 years, except for certain skin, cervical, or breast cancers.My advanced cancer (ovarian, breast, prostate) has worsened after all known beneficial treatments.My cancer is not HER2 positive.I cannot swallow or absorb pills.My brain metastases are stable, and I've been on a steady or reducing steroid dose for over a week.Participants in Phase 2 must have medical evidence showing that their condition has gotten worse despite previous treatment with PARP inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion: Recurrent Breast Cancer Cohort
- Group 2: Dose Expansion: Recurrent Epithelial Ovarian Cancer Cohort
- Group 3: Dose Escalation
- Group 4: Dose Expansion: Metastatic Castration-resistant Prostate Cancer Cohort
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.
Are volunteers being accepted to participate in this experiment?
"Per the statistics on clinicaltrials.gov, this trial is actively searching for participants with an initial post date of February 20th 2023 and a recent update from March 28th 2023."
Answered by AI
How many participants are enrolled in this investigation?
"Affirmative. Information currently displayed on clinicaltrials.gov indicates that this study is actively recruiting patients, with 115 participants needed from a single site. The trial was initially posted on February 20th 2023 and last modified on March 28th of the same year."
Answered by AI
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