DAN-222 for Metastatic Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UC San Diego Moores Cancer Center, La Jolla, CAMetastatic Breast CancerDAN-222 - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is designed to study the safety and effectiveness of two different doses of DAN-222, either alone or in combination with niraparib, in women with HER2-negative breast cancer.

Eligible Conditions
  • Metastatic Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

8 Primary · 5 Secondary · Reporting Duration: 3 years

3 years
Clearance rate
Clinical benefit rate (CBR) per RECIST v1.1, defined as the proportion of patients having a BOR of SD ≥ 6 months, PR or CR as determined by Investigator review.
Disease control rate (DCR) per RECIST v1.1, defined as best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by Investigator review.
Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by Investigator review with use of RECIST v1.1, or death from any cause during the study.
Incidence and nature of Dose Limiting Toxicities (DLTs)
Incidence, nature, and severity of adverse events graded according to NCI CTCAE v5.0
Maximum observed plasma concentration (Cmax)
Minimum observed plasma concentration (Cmin through concentration)
Objective response per RECIST v1.1, defined as the proportion of patients having a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by Investigator review.
Progression-free survival per RECIST v1.1, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier as determined by Investigator review.
Terminal half-life (t1/2)
Total exposure (area under the curve) from time 0 to the last measurable concentration (AUC0-last)
Volume of distribution

Trial Safety

Safety Progress

1 of 3

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Side Effects for

Non-gBRCA Niraparib
73%Nausea
48%Fatigue
48%Anaemia
42%Constipation
40%Thrombocytopenia
32%Vomiting
29%Decreased appetite
29%Insomnia
27%Abdominal pain
23%Headache
21%Dyspnoea
20%Hypertension
19%Platelet count decreased
19%Diarrhoea
19%Dizziness
18%Neutropenia
18%Cough
16%Asthenia
14%Back pain
13%Neutrophil count decreased
13%Nasopharyngitis
12%Arthralgia
12%Palpitations
11%Urinary tract infection
11%Photosensitivity reaction
10%Abdominal pain upper
10%Hot flush
10%Dyspepsia
10%White blood cell count decreased
10%Abdominal distension
10%Gastrooesophageal reflux disease
9%Alopecia
9%Myalgia
9%Gamma-glutamyltransferase increased
9%Anxiety
8%Hypomagnesaemia
8%Dry skin
8%Mucosal inflammation
8%Dry mouth
7%Rash
7%Pyrexia
7%Leukopenia
7%Pain in extremity
7%Oropharyngeal pain
6%Bronchitis
6%Dysgeusia
6%Muscle spasms
6%Tachycardia
6%Oedema peripheral
6%Alanine aminotransferase increased
6%Blood alkaline phosphatase increased
6%Hypokalaemia
6%Neuropathy peripheral
6%Blood creatinine increased
6%Upper respiratory tract infection
6%Aspartate aminotransferase increased
6%Sinusitis
6%Depression
5%Flatulence
5%Epistaxis
5%Stomatitis
5%Musculoskeletal pain
3%Small intestinal obstruction
3%Musculoskeletal chest pain
2%Pruritus
1%Myelodysplastic syndrome
1%Pneumonia
1%Pancytopenia
1%Pleural effusion
1%Subileus
1%Disease progression
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT01847274) in the Non-gBRCA Niraparib ARM group. Side effects include: Nausea with 73%, Fatigue with 48%, Anaemia with 48%, Constipation with 42%, Thrombocytopenia with 40%.

Trial Design

5 Treatment Groups

Dose Escalation (DAN-222)
1 of 5
Dose Escalation (DAN-222 + niraparib)
1 of 5
Dose Expansion (DAN-222)
1 of 5
Dose Expansion (DAN-222 + niraparib, HRD-positive)
1 of 5
Dose Expansion (DAN-222 + niraparib, HRD-negative)
1 of 5

Experimental Treatment

30 Total Participants · 5 Treatment Groups

Primary Treatment: DAN-222 · No Placebo Group · Phase 1

Dose Escalation (DAN-222)
Drug
Experimental Group · 1 Intervention: DAN-222 · Intervention Types: Drug
Dose Escalation (DAN-222 + niraparib)Experimental Group · 2 Interventions: DAN-222, Niraparib · Intervention Types: Drug, Drug
Dose Expansion (DAN-222)
Drug
Experimental Group · 1 Intervention: DAN-222 · Intervention Types: Drug
Dose Expansion (DAN-222 + niraparib, HRD-positive)Experimental Group · 2 Interventions: DAN-222, Niraparib · Intervention Types: Drug, Drug
Dose Expansion (DAN-222 + niraparib, HRD-negative)Experimental Group · 2 Interventions: DAN-222, Niraparib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1240

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Dantari, Inc.Lead Sponsor

Eligibility Criteria

Age 18+ · Female Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

How many individuals are being recruited to participate in this clinical examination?

"Affirmative. The information hosted on clinicaltrials.gov verifies that the experiment, which debuted on February 2nd 2022, is now enrolling patients. A total of 30 individuals must be recruited from 8 distinct locations." - Anonymous Online Contributor

Unverified Answer

Has the FDA granted authorization for DAN-222?

"At Power, we rated DAN-222's safety a 1 due to the limited evidence present in phase 1 trials that evaluate both efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Is this medical experiment currently recruiting participants?

"According to clinicaltrials.gov, this experiment is currently recruiting members; the trial was first shared on February 2nd 2022 and most recently revised on October 17th 2022." - Anonymous Online Contributor

Unverified Answer

Are there a multitude of sites conducting this clinical experiment in the urban area?

"UC San Diego Moores Cancer Center, H Lee Moffitt Cancer Center and Research Institute, Magee Women's Hospital in Pittsburgh are the three primary sites for this clinical trial with an additional 8 medical centres across the US." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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