Neoplasm Metastasis Clinical Trial
Official title:
An Open-Label, Multicenter Study of LOXO-435 (LY3866288) In Advanced Solid Tumor Malignancies With FGFR3 Alterations
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.
This is an open-label, multi-center, phase 1a/b study in participants with FGFR3-altered advanced solid tumors, including metastatic urothelial cancer (UC). The study will be conducted in 2 phases: Dose escalation and dose optimization (1a) and dose expansion (1b). Phase 1a will include up to 2 cohorts to assess safety, tolerability, and pharmacokinetics of LOXO-435 to determine the recommended phase 2 dose (RP2D) (or optimal dose). Phase 1b will include 4 dose expansion cohorts of participants with prespecified activating FGFR3 alterations to evaluate the efficacy and safety of LOXO-435 at the RP2D. Cohort B will enroll pts with metastatic UC and includes three cohorts to evaluate LOXO-435 as monotherapy (B1, B2) and in combination with pembrolizumab (B3). Cohort C will enroll pts with non-UC advanced solid tumors and includes a cohort to evaluate LOXO-435 as monotherapy (C1). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03775980 -
CIRSE Emprint Microwave Ablation Registry
|
||
| Completed |
NCT01114958 -
Pilot Study of Intra-Arterial Cisplatin With IV Thiosulfate in Patients With Lung Cancer or Lung Metastases
|
Phase 1 | |
| Terminated |
NCT03986593 -
Cryoablation of Bone Metastases From Endocrine Tumors
|
N/A | |
| Active, not recruiting |
NCT04458259 -
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
|
Phase 1 | |
| Completed |
NCT01218542 -
Whole Brain Radiation Therapy With Boost to Metastatic Tumor Volume Using RapidArc
|
N/A | |
| Not yet recruiting |
NCT03175146 -
A Study to See Whether Stereotactic Body RadioTherapy (SBRT) Can Shrink Tumours Within the Liver Safely
|
N/A | |
| Active, not recruiting |
NCT02395224 -
A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
|
||
| Completed |
NCT02374411 -
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients
|
N/A | |
| Recruiting |
NCT01960829 -
Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study
|
Phase 2 | |
| Terminated |
NCT01846429 -
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
|
Phase 1 | |
| Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
| Recruiting |
NCT01564810 -
Cetuximab in Combination With Chemotherapy for the Treatment of Metastatic Colorectal Cancer
|
Phase 4 | |
| Completed |
NCT00375245 -
Rapamycin With Grapefruit Juice for Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT00232726 -
Clinical Study of Previously Untreated Patients With Malignant Melanoma
|
Phase 2 | |
| Completed |
NCT00207116 -
An Exploratory Pharmacogenomic Study of Monotherapy Erbitux in Subjects With Metastatic Non Small Cell Lung Carcinoma
|
Phase 1 | |
| Completed |
NCT00172003 -
Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
|
Phase 4 | |
| Completed |
NCT00207103 -
MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 |