Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Tamoxifen

Hormones

Tyrosine Kinase Inhibitors

Infigratinib

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

In study part 1 (dose exploration), participants will receive up to infigratinib 100 mg. 100 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen

In study part 1 (dose exploration), participants will receive up to infigratinib 125 mg. 125 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen

In study part 1 (dose exploration), participants will receive up to infigratinib 75 mg. 75 mg of Infigratinib will be administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen

Omnipaque 350

Iopamidol

Computed tomography (CT) to assess disease state using Iopamidol and/or Omnipaque 350.

Computed tomography (CT)

Jennifer Lee Caswell-Jin

The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered breast cancer)

Primary Objective: Determine the maximum (no greater than 125 mg) dose of infigratinib used in combination with the FDA-approved dose and schedule of tamoxifen (Cohort 1) in terms of the number of dose-limiting toxicities observed in the first 2 cycles of therapy in subjects with hormone receptor-positive, HER2-negative advanced breast cancer.

Secondary Objective:

* Estimate the incidence of treatment-emergent adverse events (serious and non-serious).
* Estimate the objective tumor response rate (ORR) in subjects with measurable disease.
* Estimate the progression-free survival (PFS).
* Estimate the durable clinical benefit rate.

Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

A Phase 1B Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

The primary outcome for this study is dose-limiting toxicities (DLTs) during the first 2 cycles of therapy. All grades per the Common Terminology Criteria for Adverse Events (CTCAE). DLT is defined as a related and clinically significant adverse event (AE), including missed doses due to a related AE.

Treatment emergent adverse events (TEAEs) are defined as adverse events of any grade with initial onset or increasing in severity after the first dose of study treatment until 30 days after last dose of study drug. Pregnancy during the reporting period will be classified as a serious adverse event.

Objective tumor response will be assessed as achieving a Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Complete Response (CR) or a Partial Response (PR). The outcome will be reported as the number of subjects that achieve an overall response (OR) to treatment, ie, CR or PR, within 18 months of starting treatment. RECIST criteria are:

* CR = Disappearance of all target lesions
* PR = ≥ 30% decrease in the sum of the longest diameter of target lesions
* Overall Response (OR) = CR + PR
* Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
* Stable disease (SD) = Small changes that do not meet any of the above criteria

Progression free survival (PFS) means the participant remains alive without return or relapse of the tumor. The outcome is defined as the number of days to either progressive disease as defined per RECIST v1.1 or death. RECIST criteria are:

* CR = Disappearance of all target lesions
* PR = ≥ 30% decrease in the sum of the longest diameter of target lesions
* Overall Response (OR) = CR + PR
* Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
* Stable disease (SD) = Small changes that do not meet any of the above criteria

Clinical benefit (CB) is defined as achieving a Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Complete Response (CR) ; Partial Response (PR); or Stable Disease (SD). The outcome will be reported as the number of subjects that achieve CR, PR, or SD. RECIST criteria are:

* CR = Disappearance of all target lesions
* PR = ≥ 30% decrease in the sum of the longest diameter of target lesions
* SD = Small changes that do not meet any of the above criteria
* Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)

National Cancer Institute (NCI)

QED Therapeutics, Inc.

Assistant Professor of Medicine (Oncology)

In study part 1 (dose exploration), participants receive infigratinib up to 100 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen

Cohort 1: Infigratinib (100mg) + Tamoxifen

In study part 1 (dose exploration), participants receive infigratinib up to 125 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/ day tamoxifen

Cohort 2: Infigratinib (125mg) + Tamoxifen

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Jennifer Lee Caswell-Jin, MD

Number of Dose-limiting Toxicities (DLTs)

Number of Treatment Emergent Adverse Events (TEAE)

Objective Tumor Response Rate

Progression-free Survival (PFS)

CB (CR + PR +SD)

Participants who completed at least 6 treatment cycles are included in the analysis.

Clinical Benefit Rate

In study part 1 (dose exploration), participants receive infigratinib up to 75 mg administered orally daily, 3 weeks on, 1 week off + 20 mg/day tamoxifen

Cohort 3: Infigratinib (75mg) + Tamoxifen

Dose Level 1 (up to 18 28-day Cycles+FU)

Dose Level 2 (up to 18 28-day Cycles+FU)

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Chelating Agents

Patients undergo conventional and advanced MRI over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI over 60 minutes each between 4-16 weeks apart. Patients may receive gadolinium and/or iopamidol during MRI scans.

Advanced Magnetic Resonance Imaging

Conventional Magnetic Resonance Imaging

Gadolinium-Chelate

Jason M Johnson

This clinical trial studies the different types of investigational imaging techniques called sequences during magnetic resonance imaging (MRI) of the head before and after radiation therapy in patients with cancer that has spread to the brain (intracranial metastases). This clinical trial also compares these new techniques with standard MRI imaging to see if sequences provide better images. Diagnostic procedures, such as MRI, may help find and diagnose solid organ cancer and find out how far the disease has spread.

PRIMARY OBJECTIVES:

I. Conspicuity:

Ia. To assess the conspicuity of idealized T1 and T2 imaging at detecting brain metastases at baseline. (Quantitative MRI) Ib. To assess the conspicuity (CNR) of chemical exchange saturation transfer (CEST) imaging at detecting brain metastases at baseline. (CEST MRI) Ic. To assess the conspicuity (CNR) of advances in difference equations (Adv Diff) at detecting brain metastases at baseline. (Multiple B Value Diffusion Imaging \[Adv Diff\]) Id. To assess the conspicuity of gradient- and spin-echo (GESE) dynamic susceptibility contrast (DSC) and standard Gradient Echo (GE) DSC at detecting brain metastases at baseline. (GESE DSC perfusion imaging)

SECONDARY OBJECTIVES:

I. Conspicuity:

Ia. To assess the conspicuity of T2 imaging at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points. (Quantitative MRI) Ib. To assess the conspicuity (CNR) of CEST imaging at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points. (CEST MRI) Ic. To assess the conspicuity (CNR) of Adv Diff at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points. (Multiple B Value Diffusion Imaging \[Adv Diff\]) Id. To assess the conspicuity of GESE DSC and standard Gradient Echo (GE) DSC at detecting brain metastases on a per-patient basis at follow-up scans and on a per-lesion basis at baseline and at follow-up time points. (GESE DSC perfusion imaging) II. Treatment response. IIa. To assess the trend of idealized quantitative T1 and T2 values of brain metastases compared to normal brain parenchyma following treatment with stereotactic radiosurgery. (Quantitative MRI) IIb. To assess the ability of CEST imaging to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery. (CEST MRI) IIc. To assess whether Adv Diff can differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery. (Multiple B Value Diffusion Imaging \[Adv Diff\]) IId. To assess whether GESE DSC improves differentiation of radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery compared to standard GE DSC. (GESE DSC perfusion imaging) IIe. To assess the ability of Adv arterial spin labeling (ASL) to differentiate radiation necrosis from progressive disease in brain metastases following stereotactic radiosurgery. (Multiple inversion time \[TI\] ASL "Adv ASL" perfusion)

OUTLINE:

Patients undergo conventional and advanced MRI scans over 60 minutes within 14 days before the start of scheduled brain radiation treatment. Patients then undergo 7 additional MRI scans over 60 minutes each between 4-16 weeks apart. Patients may receive gadolinium and/or iopamidol during MRI scans.

Advanced MRI Scan Before and After Radiation Therapy for the Detection of Intracranial Metastasis

Advanced MRI for Intracranial Metastasis Treated With Stereotactic Radiosurgery

Will be performed on the largest lesion within each patient at baseline, and the analysis will be repeated considering all lesions.

The sensitivity of each method at detecting lesions as determined by T1 weighting will be reported with 95% confidence intervals. Analyses will also be performed at the subsequent scans as numbers permit.

Brain metastases "treatment response" will be defined by size and contrast to noise ratio (CNR). Size: treatment response in a lesion will be considered as a decrease in size of 30%. CNR: treatment response will be considered as a decrease in T1 post-contrast CNR of at least 20%. Metastases that do not meet these criteria for treatment response will be considered treatment failure. Will calculate the CNR in patients with lesions that respond to treatment and in patients with local failure and will compare these by using a Wilcoxon rank-sum test. If numbers permit, analyses may be repeated using all lesions. The CNR will be compared between lesions with treatment change and those that are progressive disease using a Wilcoxon rank-sum test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer	NCT04504331	Breast Cancer HER2-negative B... ER Positive Bre... PR-Positive Bre...	Infigratinib Tamoxifen Omnipaque 350 Iopamidol Computed tomogr...	18 Years -	Stanford University
Advanced MRI Scan Before and After Radiation Therapy for the Detection of Intracranial Metastasis	NCT04870645	Malignant Solid...	Advanced Magnet... Conventional Ma... Gadolinium-Chel... Iopamidol	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for iopamidol

Every month we try and update this database with for iopamidol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for iopamidol

Every month we try and update this database with for iopamidol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for iopamidol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.