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

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