Gastric Cancer Clinical Trial
Official title:
A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors
Verified date | December 2021 |
Source | Five Prime Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.
Status | Completed |
Enrollment | 79 |
Est. completion date | June 30, 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Life expectancy of at least 3 months - ECOG performance status of 0 to 1 • In sexually-active patients, willingness to use 2 effective methods of contraception - Adequate hematological and organ function, confirmed by lab values - Tumor tissue must be available for prospective determination of FGFR2b overexpression - Locally recurrent or metastatic disease that has progressed on or following standard treatment, or is not a candidate for standard treatment - Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract - Measurable disease as defined by RECIST version 1.1 Exclusion Criteria: - Untreated or symptomatic central nervous system (CNS) metastases - Impaired cardiac function or clinically significant cardiac disease - Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144 - Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI CTCAE Grade 1 - Retinal disease or a history of retinal disease or detachment - Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal transplant, or other known abnormalities of the cornea - Major surgical procedures are not allowed =28 days prior to FPA144 administration - Females who are pregnant or breastfeeding; women of childbearing potential must not be considering getting pregnant during the study - Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study - Known allergy or hypersensitivity to components of the FPA144 formulation including polysorbate - History of prior malignancy except: - a) Curatively treated non-melanoma skin cancer or - b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or - c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect - Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493, BAY1179470) of the FGF-FGFR pathway |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonbuk National University Hospital | Jeonju | Jeollabuk-do |
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | |
Korea, Republic of | Gangnam Severance Hospital | Seoul | |
Korea, Republic of | Korea University Anam Hospital | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Seoul St. Mary's Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University | Seoul | |
Korea, Republic of | SMG-SNU Boramae Medical Center | Seoul | |
Taiwan | China Medical University Hospital | Taichung | |
Taiwan | National Cheng Kung University Hospital | Tainan | |
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Veterans General Hospital | Taipei | |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | The University of Chicago Medical Center | Chicago | Illinois |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | The University of Texas M.D. Anderson Cancer Center | Houston | Texas |
United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
United States | Sarah Cannon Research Institute, LLC | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Weill Cornell Medical Center | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas |
United States | UCSF Helen Diller Family Comprehensive Cancer Center, Mission Bay | San Francisco | California |
United States | Innovative Cancer Research Institute | Whittier | California |
Lead Sponsor | Collaborator |
---|---|
Five Prime Therapeutics, Inc. |
United States, Korea, Republic of, Taiwan,
Catenacci DV, Tesfaye A, Tejani M, Cheung E, Eisenberg P, Scott AJ, Eng C, Hnatyszyn J, Marina N, Powers J, Wainberg Z. Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design. Future Oncol. 2019 Jun;15(18):2073-2082. doi: 10.2217/fon-2019-0141. Epub 2019 May 16. — View Citation
Catenacci DVT, Rasco D, Lee J, Rha SY, Lee KW, Bang YJ, Bendell J, Enzinger P, Marina N, Xiang H, Deng W, Powers J, Wainberg ZA. Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma. J Clin Oncol. 2020 Jul 20;38(21):2418-2426. doi: 10.1200/JCO.19.01834. Epub 2020 Mar 13. — View Citation
Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only). | Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs) | 4 weeks on average | |
Primary | Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only) | Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only) | 16 weeks on average | |
Secondary | Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration | Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.
• Summary of area under serum concentration-time curve, maximum serum concentration, |
16 weeks on average | |
Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | 16 weeks on average | |
Secondary | Duration of Response Per RECIST 1.1 (Part 2 Only) | Duration of complete or partial response with 95% confidence intervals in gastric cancer population. | 16 weeks on average | |
Secondary | Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve | Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.
• Summary of area under serum concentration-time curve, maximum serum concentration, |
16 weeks on average |
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