- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06317298
Fruquintinib Plus Everolimus as 2nd Line Therapy of ccRCC Patients Progressed Post IO and TKI Therapy
March 18, 2024 updated by: Peking University First Hospital
Efficacy and Safety of Fruquintinib in Combination With Everolimus as Second Line Therapy of ccRCC Patients Progressed Post Immunotherapy and Tyrosine Kinase Inhibitors Therapy: a Prospective, Single Arm, Phase II Clinical Trial
This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor.
Patients will receive fruquintinib 4mgQd/5mgQd 21days on/7 days off plus everolimus 5mg Qd as the dose escalation phase indicates.
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhisong He, M.D
- Phone Number: +8610-83572418
- Email: wyj7074@sohu.com
Study Contact Backup
- Name: Kaiwei Yang, M.D
- Phone Number: 13811501435
- Email: 13811501435@163.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking University First Hospital
-
Contact:
- Zhisong He, MD
- Phone Number: +8610-83572418
- Email: wyj7074@sohu.com
-
Contact:
- Kaiwei Yang, MD
- Phone Number: 13811501435
- Email: 13811501435@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ≥18 and ≤75 years of age
- Able to Sign informed consent form independently.
- Stage IV clear cell renal cell carcinoma.
- Subjects must have progressed after IO-TKI therapy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Subjects must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start;
- Serum potassium ≥ 3.5 mmol/L;
- Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine < 2.0 x ULN.
Exclusion Criteria:
- Have received approved systemic anti-tumor therapy within 2 weeks prior to the first administration, including but not limited to:TKI (TKI with a washout period of 2 weeks or 5 half-lives, whichever is shorter), traditional Chinese medicine treatment (Chinese medicine treatment with anti-tumor indications in the instructions, which can be washed out for 1 week before the first administration), cytokine therapy, etc; Has received any one of the drugs in this study for treatment
- Participated in or participated in another intervention clinical study within 4 weeks prior to the first administration, except for an observational (non intervention) clinical study or being in the survival follow-up stage of an intervention study;
- Within 60 days prior to the first medication use, significant surgical procedures (such as craniotomy, thoracotomy, or laparotomy, as defined by the researcher) have been performed;
- Have undergone any surgery or invasive treatment within 4 weeks prior to the first medication use (fistula surgery requires stable fistula formation for 4 weeks, except for renal/bladder puncture fistula, puncture biopsy, and venous catheterization); Or unhealed wounds, ulcers, fractures, or significant surgery expected during the course of this study (note: local treatment for isolated lesions is acceptable for palliative purposes);
- Received radiation therapy within one week before the first medication; Received curative radiotherapy (including over 25% bone marrow radiotherapy) within the first 4 weeks of screening;
- Perform close range radiotherapy (such as implanting radiation particles) within 60 days before the first medication;
- Toxicity caused by previous anti-tumor therapy prior to initial use that has not recovered to the level specified in the American Cancer Society Adverse Event General Terminology (NCI CTCAE) v5.0 ≤ 1 or inclusion criteria;
- Allergies to fruquintinib, everolimus or other rapamycin analogues (sirolimus etc), or their excipients;
- Individuals who have developed other malignant tumors within the 5 years prior to enrollment, excluding clinically cured cervical carcinoma in situ/basal cell carcinoma of the skin/squamous cell carcinoma of the skin/ductal carcinoma in situ of the breast, and localized prostate cancer that has undergone radical treatment;
- Known to have central nervous system (CNS) metastasis and/or spinal cord compression and/or cancerous meningitis, with a history of leptomeningeal carcinoma;
- The known history of liver diseases with clinical significance, including those with active viral hepatitis (when hepatitis B virus surface antigen (HBsAg) and or hepatitis B virus core antibody (HbcAb) are positive, hepatitis B B virus (HBV) DNA>10000 copies/mL or>2000 IU/mL; Hepatitis C virus (HCV) antibody positive and HCV RNA positive, or other active hepatitis with clinically significant moderate to severe cirrhosis;
- The patient currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation; Or those who have a history of gastrointestinal perforation or fistula and have not recovered after surgical treatment;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting surgery within the first 6 months of screening; Congestive heart failure: New York Heart Association (NYHA) grade ≥ 2; Left ventricular ejection fraction (LVEF)<50%;
- The patient currently has uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) even after receiving standardized treatment;
- The patient currently has any disease or condition that affects drug absorption, or the patient is unable to administer the medication orally;
- Patients with evidence of bleeding tendency or medical history within 2 months prior to the first medication (such as black stools, vomiting blood, hemoptysis, bloody stools, etc.), regardless of severity (excluding hemorrhoid bleeding);
- Have a history of arterial thrombosis or deep vein thrombosis within 6 months before the first medication; Or have experienced stroke events and/or transient ischemic attacks within 12 months; Except for patients with thrombosis caused by implantable intravenous infusion pumps or catheters, or those with superficial venous thrombosis who have stabilized after regular anticoagulation treatment;
- During screening, it was found that the tumor invaded large vascular structures, such as pulmonary arteries, superior vena cava, or inferior vena cava, and the researcher determined that there was a significant risk of bleeding;
- May lead to other acute or chronic diseases or abnormal laboratory test values: increase the risk of research participation or drug administration, or interfere with the interpretation of research results, and classify patients as ineligible to participate in this study based on the researcher's judgment;
- Pregnant (positive pregnancy test) or lactating female patients;
- Have a history of interstitial lung disease, non infectious pneumonia, or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc;
- Severe chronic or active infections (including pulmonary tuberculosis infection) that require systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to administration; Patients receiving prophylactic antibiotic treatment (such as for preventing urinary tract infections, chronic obstructive pulmonary disease, or tooth extraction);
- Received live vaccination within 14 days before administration;
- Known history of HIV infection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fruquintinib(3mg) plus Everolimus
Fruquintinib 3mg Qd 21 days on 7 days off; Everolimus 5mg Qd; 28 day cycle until disease progression or intolerable adverse events
|
Fruquintinib and Everolimus
|
Experimental: Fruquintinib(4mg) plus Everolimus
Fruquintinib 4mg Qd 21 days on 7 days off; Everolimus 5mg Qd; 28 day cycle until disease progression or intolerable adverse events
|
Fruquintinib and Everolimus
|
Experimental: Fruquintinib(5mg) plus Everolimus
Fruquintinib 5mg Qd 21 days on 7 days off; Everolimus 5mg Qd; 28 day cycle until disease progression or intolerable adverse events
|
Fruquintinib and Everolimus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD (Maximum Tolerated Dose)
Time Frame: 6 month
|
the maximum dose in which the proportion of patients who experience dose limited toxicity (DLT) within 28 days after the first dose level is less than or equal to 1/6.
When DLT occurs in patients with a dose level greater than 1/6, a dose level lower than this dose level is considered MTD.
The MTD dose group requires at least 6 DLT evaluable patients to be confirmed.
|
6 month
|
ORR (Objective Response Rate)
Time Frame: 1 year
|
Based on the evaluable set of tumor efficacy, it is defined as the sum of the proportions of patients with confirmed complete response (CR) or partial response (PR) as the best overall evaluation per RECIST(Response Evaluation Criteria In Solid Tumors )1.1criteria
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS (Progression Free Survival)
Time Frame: 1 year
|
The time from when the patient starts receiving the study drug until disease progression (according to RECIST 1.1) or death occurs, whichever occurs first
|
1 year
|
DCR (Decease Control Rate )
Time Frame: 1 year
|
The best overall assessment is the sum of the proportions of patients who have confirmed CR, PR, and disease stability (SD) (according to RECIST 1.1)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2024
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 5, 2023
First Submitted That Met QC Criteria
March 18, 2024
First Posted (Actual)
March 19, 2024
Study Record Updates
Last Update Posted (Actual)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protein Kinase Inhibitors
- MTOR Inhibitors
- Everolimus
Other Study ID Numbers
- 2023-013-CH01 IIT-RCC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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