Bgj398 clinical trial

Study record managers: refer to the Data Element Definitions if submitting registration or results information. Secondary Outcome Measures : Overall survival in participants treated with infigratinib versus gemcitabine with cisplatin [ Time Frame: Approximately 15 months on average ] Defined as time from date of randomization until death due to any cause Investigator assessed progression free survival in participants treated with infigratinib compared to gemcitabine and cisplatin [ Time Frame: Approximately 10 months on average ] Defined as the time from randomization until date of disease progression by site investigator RECIST v1.

Evaluate the efficacy in participants treated with infigratinib versus gemcitabine with cisplatin by overall response rate ORR determined by blinded independent central assessment and the investigator. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Received treatment with any systemic anti-cancer therapy for unresectable locally advanced or metastatic cholangiocarcinoma, with following exceptions.

Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.

Federal Government. The baseline visit will be a 1-week stay in the clinic. Participants will have the regular study tests, plus:. Participants will take the study drug for six 1-month cycles. In each cycle, participants will:. Participants will have 1 visit at the end of the last cycle and another 3 months later Treatment duration of 6 months with 3 months off drug follow-up and optional extension phase.

The six cycles of BGJ will be followed by 3 months off the drug and an optional extension phase. A participant was considered to have a complete metabolic remission by achieving both normal blood FGF23 and phosphorus levels in the blood for 12 weeks after stopping BGJ A participant was considered to have a complete metabolic response by achieving both normal c-terminal FGF23 and phosphorus levels at each time point.

Each subject was instructed to complete the maximum distance possible in six minutes. Feedback was given in two minute intervals and during the last 30 seconds. Patients were instructed to notify test administrator of leg cramping, pain, nausea, dizziness and shortness of breath.

Test administrators counted each lap and upon test completion, the partial distance is measured and added to where the subject stopped. Hand Grip Strength Test [ Time Frame: Assessed at baseline and every 4 weeks up to 24 weeks during the treatment phase, and every 4 weeks in the follow up phase, up to 37 weeks ] The person is seated, lower extremities flexed at 90 degrees.

The individual uses the dominant hand for this activity. The individual sit with shoulder adducted and neutrally rotated elbow flexed at 90 degrees, forearm in neutral position, resting on the arm of a chair. The examiner lightly supports the readout dial to prevent it from dropping.

The patient is asked to "Squeeze as hard as you can…. A second break occurs to prevent muscle fatigue. Scores are recorded and averaged for the final result. Scores within two standard deviations of the mean are considered within normal limits. Pinch Test [ Time Frame: Assessed at baseline and every 4 weeks for the 24 treatment period, and every 4 weeks in the follow up phase, up to 37 weeks ] A lateral pinch is required of the patient, using the dominant hand.

The individual is seated, lower extremities flexed at 90 degrees. The examiner stabilizes the patient's wrist as the patient holds the pinch gauge to perform the test. The examiner requests the person to pinch with maximum strength. The peak-hold needle will automatically record the highest force exerted.

After the patient uses the Pinch gauge, the examiner records the reading and resets the peak-hold needle to zero before testing again. Three lateral pinch trials are recorded and averaged for the final result. The chair is free standing. Patient sits with arms folded across chest and with their back against the chair. A standard chair height 44 cm was used for each patient. Patient stands fully between repetitions of the test, careful to not touch the back of the chair during each repetition.

Patient instructions: "I want you to stand up and sit down 5 times as quickly as you can when I say Go. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion criteria: - Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Infigratinib BGJ in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study.

Lancet Gastroenterol Hepatol. Epub Aug 3. J Clin Oncol. Epub Nov Fibroblast growth factor receptor 2 fusions as a target for treating cholangiocarcinoma.

Curr Opin Gastroenterol. National Library of Medicine U. The duration of response PR or greater applies only to patients whose best response was PR or greater. It is defined as the Ttime from the first documented response to the date first documented disease progression or relapse or death due to any cause.

Eligibility Criteria. Inclusion Criteria: Patient has a confirmed diagnosis of a select solid tumor except with a primary diagnosis of Urothelial cell carcinoma, Cholangiocarcinoma, Endometrial cancer, and Glioblastoma multiforme or hematologic malignancies and is in need of treatment because of progression or relapse. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Solid Tumor Hematologic Malignancies. Drug: BGJ Phase 2. Study Type :. Interventional Clinical Trial. Actual Enrollment :.