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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial tests a new drug called DAN-222 alone and with another drug, niraparib. Niraparib is an oral medication approved for maintenance treatment in ovarian, fallopian tube, or primary peritoneal cancer. It likely targets cancer patients who need new treatment options. DAN-222's effects are being studied, while niraparib helps kill cancer cells by stopping them from repairing their DNA.
Eligible Conditions
- Metastatic Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Escalation (DAN-222)Experimental Treatment1 Intervention
The starting dose of DAN-222 will be administered IV every week (QW) to subjects in the first cohort.
Group II: Dose Escalation (DAN-222 + niraparib)Experimental Treatment2 Interventions
The starting dose of DAN-222 will be administered IV every week (QW), in combination with daily oral niraparib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DAN-222
2022
Completed Phase 1
~30
Niraparib
FDA approved
Find a Location
Who is running the clinical trial?
Dantari, Inc.Lead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious medical, social or mental condition that may put you at risk during the study, or may make it difficult for you to follow the study instructions.You have had a type of blood cancer called myelodysplasia or have had another type of cancer that has required treatment within the last three years, except for non-melanoma skin cancer or carcinoma in situ.You cannot participate in the DAN-222 and niraparib combination study if you are allergic to FD&C Yellow No. 5 (tartrazine).
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation (DAN-222 + niraparib)
- Group 2: Dose Escalation (DAN-222)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
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