CFI-402257 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+1 MoreCFI-402257 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing an investigational drug to see if it is safe to use alone or with another drug to treat people with advanced solid tumors or advanced breast cancer.

Eligible Conditions
  • Advanced Solid Tumors
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 48 months

48 months
Assessment of objective response rates
Assessment of objective response rates of the combination
Assessment of the pharmacokinetic profile of CFI-402257 in combination with fulvestrant through AUC
Assessment of the pharmacokinetic profile of CFI-402257 through AUC
To assess the incidence of adverse events of CFI-402257 as a single agent and at the recommended phase 2 dose (RP2D)
To assess the incidence of adverse events of CFI-402257 in combination with fulvestrant and at the recommended phase 2 dose (RP2D)
To evaluate the effect of CFI-402257 treatment on changes in variant allele function

Trial Safety

Safety Progress

1 of 3

Side Effects for

Dovitinib
50%DECREASED APPETITE
30%CONSTIPATION
30%PAIN IN EXTREMITY
30%RASH
30%DIARRHOEA
20%OEDEMA PERIPHERAL
20%ANAEMIA
20%FATIGUE
20%COUGH
20%HEADACHE
20%ANGINA PECTORIS
20%GAMMA-GLUTAMYLTRANSFERASE INCREASED
20%NASOPHARYNGITIS
10%PYREXIA
10%HERPES ZOSTER
10%NEURALGIA
10%INSOMNIA
10%PLEURAL EFFUSION
10%BLOOD ALKALINE PHOSPHATASE INCREASED
10%CORONARY ARTERY DISEASE
10%BRADYCARDIA
10%PNEUMONIA
10%PNEUMOTHORAX
10%NAUSEA
10%GASTROOESOPHAGEAL REFLUX DISEASE
10%ABDOMINAL PAIN
10%FACE OEDEMA
10%DYSPEPSIA
10%PLATELET COUNT DECREASED
10%ARTHRITIS
10%ASPARTATE AMINOTRANSFERASE INCREASED
10%MUSCULOSKELETAL PAIN
10%INTERNATIONAL NORMALISED RATIO INCREASED
10%HYPERTRIGLYCERIDAEMIA
10%HYPERKALAEMIA
10%RESTLESSNESS
10%MUSCLE SPASMS
10%DYSPNOEA
10%DYSPNOEA EXERTIONAL
10%SKIN LESION
10%MYOCARDIAL ISCHAEMIA
10%EYE OEDEMA
10%LEUKOPENIA
10%INCREASED TENDENCY TO BRUISE
10%NEUTROPENIA
10%ASTHENIA
10%INFLUENZA
10%CONTUSION
10%LYMPHOCYTE COUNT DECREASED
10%HYPOCALCAEMIA
10%ARTHRALGIA
10%PRURITUS
10%BLOOD CREATININE INCREASED
10%HYPOTHYROIDISM
10%PRODUCTIVE COUGH
10%DRY MOUTH
This histogram enumerates side effects from a completed 2016 Phase 2 & 3 trial (NCT02116803) in the Dovitinib ARM group. Side effects include: DECREASED APPETITE with 50%, CONSTIPATION with 30%, PAIN IN EXTREMITY with 30%, RASH with 30%, DIARRHOEA with 30%.

Trial Design

2 Treatment Groups

Part A: Monotherapy Escalation and Expansion
1 of 2
Part B: Combination Escalation and Expansion
1 of 2

Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: CFI-402257 · No Placebo Group · Phase 1 & 2

Part A: Monotherapy Escalation and Expansion
Drug
Experimental Group · 1 Intervention: CFI-402257 · Intervention Types: Drug
Part B: Combination Escalation and ExpansionExperimental Group · 2 Interventions: CFI-402257, Fulvestrant · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3810

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 months

Who is running the clinical trial?

Treadwell Therapeutics, IncLead Sponsor
3 Previous Clinical Trials
259 Total Patients Enrolled
R WesolowskiPrincipal InvestigatorThe Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have clinical chemistry, hematology, and urinalysis results within certain limits specified.
You have advanced cancer that has progressed on at least 1 prior line of systemic therapy.
You have measurable or nonmeasurable disease as per RECIST 1.1 guidelines or other appropriate disease assessment guidelines.
You are at least 18 years of age.