A Multi-Center Open-Label Study of Fruquintinib in Solid Tumors Colorectal and Breast Cancer

  • STATUS
    Recruiting
  • End date
    Dec 15, 2021
  • participants needed
    130
  • sponsor
    Hutchison Medipharma Limited
Updated on 17 February 2021
cancer
breast cancer
vegf
oxaliplatin
adenocarcinoma of the colon
fluoropyrimidine
HER2
EGFR
irinotecan
metastatic colorectal cancer
bevacizumab
tas-102
solid tumors
biological therapy
adenocarcinoma
solid tumour
triple negative breast cancer
stage iv breast cancer
erbb2
vascular endothelial growth factor
adjuvant chemotherapy
adenocarcinoma of colon
regorafenib
hmpl-013
fruquintinib
immunological adjuvant
tumors, colorectal

Summary

An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.

Description

The study is an open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors. The study will consist of two phases:

  • A dose escalation phase - A 3+3 design will be used for this portion of the study.
  • A dose expansion phase - Five cohorts will be evaluated in Dose Expansion. Cohort A will evaluate the MTD/RP2D in patients with advanced solid tumors. Cohort B and Cohort C will evaluate the MTD/RP2D in metastatic colorectal cancer patients. Cohort D and Cohort E will evaluate the MTD/RP2D in metastatic breast cancer patients.

Study will be conducted in up to 9 sites in the US.

Details
Condition Colorectal Cancer, Rectal Cancer, Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Colon Cancer Screening, Colon cancer; rectal cancer, Advanced Solid Tumors, Metastatic Breast Cancer, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, HER2 Negative Breast Cancer, Stage IV Breast Cancer, Brain Function, Metastatic Colon Cancer, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, Hormone Receptor Positive Breast Carcinoma, rectal carcinoma
Treatment Fruquintinib (HMPL-013)
Clinical Study IdentifierNCT03251378
SponsorHutchison Medipharma Limited
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: or Recurrent Respiratory Papillomatosis or Hormone Receptor Positive Breast Carcinoma or HER2 Negative Breast Cancer or Injection Port or Colon cance...?
Do you have any of these conditions: or Advanced Solid Tumors or Anal Dysplasia or Pediatric Health or Colorectal Cancer or Triple Negative Breast Cancer or Breast Cancer - HER2 Positive...?
Do you have any of these conditions: Metastatic Colon Cancer or Colon Cancer Screening or Advanced Solid Tumors or Metastatic Triple-Negative Breast Cancer or Brain Function or Chronic Sh...?
Fully understand the study and voluntarily sign the ICF
years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Dose Escalation Phase
Histologically or cytologically documented, locally advanced or metastatic
solid malignancy of any type (except squamous NSCLC) that has progressed on
approved systemic therapy, and for whom no effective therapy or standard of
care exists. This cohort is closed to enrollment
Dose Expansion Phase
Cohort A: Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type (except squamous NSCLC), that has progressed on approved systemic therapy, and for whom no effective therapy or standard of care exists. This cohort is closed to enrollment
Cohort B: Histologically or cytologically documented mCRC in patients that have progressed on, or had intolerable toxicity with at least 1 FDA-approved third-line systemic therapy (trifluridine/tipiracil or regorafenib). Patients must also have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and an anti-EGFR therapy for patients who had RAS wild-type tumors. This cohort is currently enrolling
Cohort C: Histologically or cytologically documented adenocarcinoma of the colon or rectum. Patients must have progressed on, or had intolerable toxicity to, at least 2 prior regimens of standard chemotherapy, but must not have received prior TAS-102 or regorafenib. Prior therapy could have included adjuvant chemotherapy if a tumor had recurred within 6 months after the last administration of treatment. Patients must have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy
Cohort D only: Histologically- or cytologically-confirmed Her2-negative, hormone receptor positive (ER+ and/or PR+) breast cancer
Cohort E only: Histologically- or cytologically- confirmed triple negative breast cancer

Exclusion Criteria

Patients will be excluded from the study, if any of the following criteria is
met
Severe anemia, neutropenia, thrombocytopenia
Moderate to severe renal or hepatic impairment
Uncontrolled hypertension
Risk of, or active hemorrhage: history or presence of active gastric/duodenal ulcer or ulcerative colitis, active hemorrhage of an unresected gastrointestinal tumor, history of perforation of fistulas; or any other condition that could possibly result in gastrointestinal tract hemorrhage or perforation within 6 months prior to screening
History of a thromboembolic event (including deep vein thrombosis [DVT], pulmonary embolism, stroke and/or transient ischemic attack) within 6 months prior to screening
Patients with squamous NSCLC
Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction or coronary artery bypass surgery within 6 months prior to enrollment, severe or unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment, or left ventricular ejection fraction (LVEF) <50%
Patients who have ever received a VEGFR inhibitor, except for patients with mCRC enrolled in the dose expansion phase
Systemic anti-neoplastic therapies or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy
Systemic small molecule targeted therapies (eg, tyrosine kinase inhibitors) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug
Palliative radiotherapy for bone metastasis/lesion within 2 weeks prior to the initiation of study drug
Brachytherapy (ie, implantation of radioactive seeds) within 60 days prior to the first dose of study drug
Known human immunodeficiency virus (HIV) infection
Known clinically significant history of liver disease, including cirrhosis, current alcohol abuse or active viral hepatitis. For patients with evidence of chronic hepatitis B (HBV), the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Tumor invasion of a large vascular structure, eg, pulmonary artery, superior or inferior vena cava
Women who are pregnant or lactating
Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; patients requiring steroids within 4 weeks prior to start of study treatment will be excluded
No other malignancy, except for non-melanoma skin cancer, during the 5 years prior to screening
Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery (eg, gastric bypass) or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product
Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at undue risk of harm based on the investigator's assessment
Known hypersensitivity to fruquintinib or any of its excipients
For Cohort C only: patients who have been previously treated with TAS-102 or regorafenib
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