Therapy Detail

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Therapy Name Cabozantinib
Synonyms
Therapy Description

Cometriq (Cabometyx, cabozantinib) inhibits several receptor tyrosine kinases, including VEGFR2, FLT3, AXL, MET, RET, ROS1 fusions, and c-KIT (PMID: 27370605, PMID: 21926191). Cometriq (cabozantinib) is FDA approved for medullary thyroid cancer and Cabometyx (cabozantinib) is FDA approved for advanced renal cell carcinoma and in sorafenib previously treated hepatocellular carcinoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cabozantinib Cometriq Cabometyx|Cabozantinib-s-malate|XL184 AXL Inhibitor 29 FLT3 Inhibitor 56 KIT Inhibitor 51 MET Inhibitor 53 RET Inhibitor 39 ROS1 Inhibitor 14 VEGFR2 Inhibitor 35 Cometriq (Cabometyx, cabozantinib) inhibits several receptor tyrosine kinases, including VEGFR2, FLT3, AXL, MET, RET, ROS1 fusions, and c-KIT (PMID: 27370605, PMID: 21926191). Cometriq (cabozantinib) is FDA approved for use in patients with medullary thyroid cancer, Cabometyx (cabozantinib) is FDA approved for use in patients with advanced renal cell carcinoma, hepatocellular carcinoma previously treated with sorafenib, adult and pediatric patients 12 years and older with locally advanced or metastatic differentiated thyroid cancer, and in combination with Opdivo (nivolumab) in patients with advanced renal cell carcinoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KIT W557_K558del Advanced Solid Tumor sensitive Cabozantinib Preclinical - Cell culture Actionable In a preclinical study, Cometriq (Cabometyx, cabozantinib) treatment resulted in decreased viability of transformed cells expressing KIT W557_K558del in culture (PMID: 33212994). 33212994
RET over exp Advanced Solid Tumor predicted - sensitive Cabozantinib Preclinical - Cell line xenograft Actionable In a preclinical study, Cometriq (Cabometyx, cabozantinib) treatment resulted in moderate tumor volume reduction in a cell line xenograft model of transformed cells overexpressing RET (PMID: 30446652). 30446652
RET M918T thyroid gland medullary carcinoma sensitive Cabozantinib Case Reports/Case Series Actionable In a clinical case study, Cometriq (cabozantinib) treatment resulted in a partial response in a patient with medullary thyroid carcinoma with extensive CNS metastasis harboring MET M918T, although the patient experienced multiple adverse effects and her disease progressed after 8 months of treatment (PMID: 33154983). 33154983
RET M918T thyroid gland medullary carcinoma sensitive Cabozantinib Phase III Actionable In a Phase III trial, Cometriq (cabozantinib) treatment resulted in improved progression free survival (61 vs 17 weeks) compared to placebo in thyroid medullary carcinoma patients harboring RET M918T (PMID: 27525386). 27525386
RET M918T thyroid gland medullary carcinoma sensitive Cabozantinib Phase III Actionable In a Phase III trial, Cometriq (cabozantinib) increased overall survival to 25.4 months in medullary thyroid carcinoma patients with RET M918T (J Clin Oncol 33, 2015, suppl; abstr 6012). detail...
KIT T670I Advanced Solid Tumor sensitive Cabozantinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing KIT T670I demonstrated sensitivity to Cometriq (Cabometyx, cabozantinib) treatment in culture, resulting in reduced cell viability (PMID: 33212994). 33212994
RET rearrange lung adenocarcinoma predicted - sensitive Cabozantinib Phase II Actionable In a Phase II trial, treatment with Cometriq (cabozantinib) resulted in an overall response rate of 28% (7/25) in patients with RET-rearranged lung adenocarcinoma, with a median duration of response of 7.0 months (PMID: 27825636; NCT01639508). 27825636
KIT act mut gastrointestinal stromal tumor sensitive Cabozantinib Preclinical Actionable In a preclinical study, Cometriq (cabozantinib) decreased cell viability in imatinib-sensitive and resistant gastrointestinal stromal tumor (GIST) cell lines harboring KIT activating mutations in culture, and induced tumor regression in KIT-mutant GIST mouse models (PMID: 25836719). 25836719
RET rearrange lung non-small cell carcinoma sensitive Cabozantinib Guideline Actionable Cometriq (cabozantinib) is in guidelines for non-small cell lung cancer patients with RET rearrangements (NCCN.org). detail...
RET rearrange lung non-small cell carcinoma sensitive Cabozantinib Clinical Study Actionable In a clinical study, analysis of patients with RET-rearranged non-small cell lung cancer treated with RET inhibitors demonstrated a response rate of 37% (7/19), with complete response in 5% (1/19) and partial response in 32% (6/19) of patients, and stable disease in 26% (5/19) of patients following Cometriq (cabozantinib) treatment (PMID: 28447912). 28447912
HRAS mutant thyroid gland medullary carcinoma sensitive Cabozantinib Phase III Actionable In a Phase III trial, Cometriq (cabozantinib) treatment resulted in improved progression free survival (47 vs 8 weeks) compared to placebo in thyroid medullary carcinoma patients harboring RAS mutations (PMID: 27525386). 27525386
FLT3 exon 14 ins Advanced Solid Tumor predicted - sensitive Cabozantinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing a FLT3-ITD mutation were sensitive to Cometriq (cabozantinib) in culture (PMID: 21926191). 21926191
KIT D816V Advanced Solid Tumor resistant Cabozantinib Preclinical Actionable In a preclinical study, transformed cells expressing KIT D816V demonstrated resistance to Cometriq (cabozantinib) in culture (PMID: 24205792). 24205792
CTNNB1 mutant endometrial cancer predicted - sensitive Cabozantinib Case Reports/Case Series Actionable In a Phase II (NCI9322/PHL86) trial, Cometriq (Cabometyx, cabozantinib) treatment resulted in a response rate of 40% (4/10) and a 12-week progression-free survival rate of 70% (7/10) in patients with endometrial cancer harboring CTNNB1 mutations, with a median PFS of 7.6 months (PMID: 31992589; NCT01935934). 31992589
KIT K558_G565delinsR gastrointestinal stromal tumor sensitive Cabozantinib Preclinical - Pdx Actionable In a preclinical study, Cometriq (Cabometyx, cabozantinib) resulted in tumor regression, decreased mitotic activity, and increased apoptotic activity in a gastrointestinal stromal tumor patient derived xenograft (PDX) model harboring KIT K558_G565delins (PMID: 27777285). 27777285
RET mutant thyroid gland medullary carcinoma sensitive Cabozantinib Phase III Actionable In a Phase III trial, Cometriq (cabozantinib) treatment resulted in improved progression free survival (60 vs 20 weeks) compared to placebo in thyroid medullary carcinoma patients harboring RET mutations (PMID: 27525386). 27525386
KIT N655K Advanced Solid Tumor decreased response Cabozantinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing KIT N655K demonstrated a reduced response to Cometriq (Cabometyx, cabozantinib) treatment compared to cells expressing KIT T670I in culture (PMID: 33212994). 33212994
KIT W557Lfs*5 KIT P577del KIT D820G gastrointestinal stromal tumor sensitive Cabozantinib Preclinical - Pdx Actionable In a preclinical study, Cometriq (Cabometyx, cabozantinib) slowed tumor growth and decreased mitotic activity in a gastrointestinal stromal tumor patient derived xenograft (PDX) model harboring KIT mutations, P577del, W557Lfs*5, and D820G (PMID: 27777285). 27777285
KIT A502_Y503dup gastrointestinal stromal tumor sensitive Cabozantinib Preclinical - Pdx Actionable In a preclinical study, Cometriq (Cabometyx, cabozantinib) resulted in decreased tumor volume and reduced mitotic activity in a gastrointestinal stromal tumor patient derived xenograft (PDX) model harboring KIT A502_Y503dup (PMID: 27777285). 27777285
RET C634W thyroid gland carcinoma sensitive Cabozantinib Preclinical - Cell line xenograft Actionable In a preclinical study, Cometriq (cabozantinib) inhibited phosphorylation of RET C634W and decreased tumor growth in xenograft models of a human thyroid carcinoma cell line harboring RET C634W mutation (PMID: 23705946). 23705946

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04116541 Phase II Alectinib Cabozantinib HDM201 + Ribociclib A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. (MegaMOST) Recruiting 1
NCT04767906 Phase II Cabozantinib Cabozantinib Treatment in a Phase II Study for Patients With Hepatocellular Carcinoma (HCC) Refractory to PD-1 Inhibitors (CaPture) Recruiting 1
NCT04205799 Phase II Cabozantinib Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure (CABOCOL-01) Recruiting 1
NCT01866293 Phase Ib/II Cabozantinib Cabozantinib (XL184) in Patients With Relapsed or Refractory Myeloma Completed USA 0
NCT04876456 Phase II Cabozantinib A Phase II Trial Evaluating the Efficacy of Cabozantinib With Patients With Refractory GCTs Recruiting USA 0
NCT03878524 Phase I Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) Recruiting USA 0
NCT03945773 Phase II Cabozantinib Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal Cell Carcinoma (RCC) With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors (CaboPoint) Recruiting 7
NCT04497038 Phase Ib/II Cabozantinib Cabozantinib in Patients With Advanced Hepatocellular Carcinoma With Child Pugh Class B Cirrhosis After First-Line Therapy Recruiting USA 0
NCT02041260 Phase II Cabozantinib A Phase II Trial of Cabozantinib for the Treatment of Radioiodine (RAI)-Refractory Differentiated Thyroid Carcinoma (DTC) in the First-line Setting Active, not recruiting USA 0
NCT03370718 Phase II Cabozantinib Cabozantinib in Unresectable/Metastatic Adrenocortical Carcinoma Active, not recruiting USA 0
NCT01908426 Phase III Cabozantinib Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib Completed USA | CAN 17
NCT02795156 Phase II Cabozantinib Afatinib Regorafenib Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations Recruiting USA 0
NCT01935934 Phase II Cabozantinib Cabozantinib-S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer Active, not recruiting USA | CAN 0
NCT01703065 Phase I Cabozantinib Cabozantinib in Treating Men With Castration-Resistant Prostate Cancer Terminated USA 0
NCT04551430 Phase II Cabozantinib + Ipilimumab + Nivolumab Cabozantinib Cabozantinib Combined With PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue Sarcoma Recruiting USA 0
NCT01688999 Phase II Cabozantinib Cabozantinib for Advanced Urothelial Cancer Active, not recruiting USA 0
NCT02132598 Phase II Cabozantinib Trial of Cabozantinib (XL184) in Non-Small Cell Lung Cancer With Brain Metastases Terminated USA 0
NCT02885324 Phase II Cabozantinib Pilot Study of Cabozantinib for Recurrent or Progressive High-Grade Glioma in Children Recruiting USA 0
NCT02101736 Phase II Cabozantinib Cabozantinib for Plexiform Neurofibromas (PN) in Subjects With NF1 (16 Years +) Active, not recruiting USA 0
NCT03755791 Phase III Cabozantinib Sorafenib Atezolizumab + Cabozantinib Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy (COSMIC-312) Recruiting USA | CAN 32
NCT01835145 Phase II Dacarbazine Temozolomide Cabozantinib Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Melanoma of the Eye Active, not recruiting USA | CAN 0
NCT01466036 Phase II Cabozantinib Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors Active, not recruiting USA 0
NCT04134390 Phase II Cabozantinib Study of Cabozantinib Efficacy, Safety and Tolerability in Metastatic Renal Carcinoma in Aged Fragile Patients: CABOMAYOR Study (CABOMAYOR) Recruiting 1
NCT01709435 Phase I Cabozantinib Cabozantinib in Treating Younger Patients With Recurrent or Refractory Solid Tumors Completed USA | CAN 0
NCT04338269 Phase III Cabozantinib Atezolizumab + Cabozantinib A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment (CONTACT-03) Recruiting USA | CAN 13
NCT02761057 Phase II Savolitinib Cabozantinib Crizotinib Sunitinib Cabozantinib-S-Malate, Crizotinib, Volitinib, or Sunitinib Malate in Treating Patients With Locally Advanced or Metastatic Kidney Cancer Active, not recruiting USA | CAN 0
NCT03967522 Phase II Cabozantinib Evaluation of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases (CABRAMET) Recruiting 1
NCT03612232 Phase II Cabozantinib Cabozantinib in Advanced Adrenocortical Carcinoma (CaboACC) Recruiting 1
NCT03793166 Phase III Nivolumab Cabozantinib + Nivolumab Cabozantinib Ipilimumab + Nivolumab Nivolumab and Ipilimumab Followed by Nivolumab Versus Cabozantinib and Nivolumab in Treating Patients With Metastatic Untreated Renal Cell Cancer Recruiting USA 1
NCT04300140 Phase Ib/II AVB-S6-500 + Cabozantinib Cabozantinib Efficacy and Safety Study of AVB-S6-500 in Patients With Clear Cell Renal Cell Carcinoma Recruiting USA 0
NCT02302833 Phase I Cabozantinib Cabozantinib for Malignant Pheochromocytoma Recruiting USA 0
NCT01834651 Phase II Cabozantinib A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases Completed USA 0
NCT01979393 Phase II Cabozantinib IRCI Gynae Sarcomas, High Grade Uterine Sarcoma Active, not recruiting 6
NCT04131543 Phase II Cabozantinib Phase II Study With Cabozantinib in Patients With RET Positive NSCLC (CRETA) Recruiting 1
NCT03943602 Phase II Cabozantinib Cabozantinib in Patients With Advanced Penile Squamous Cell Carcinoma (PSCC) (CaboPen) (CaboPen) Recruiting 1
NCT04220229 Phase Ib/II Cabozantinib Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities Recruiting USA 0
NCT01835158 Phase II Cabozantinib Cabozantinib + Sunitinib Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer Completed USA 0
NCT02315430 Phase II Cabozantinib Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Completed USA 0
NCT01582295 Phase I Cabozantinib XL184 For Relapsed/Refractory Multiple Myeloma (MM) With Bone Disease Completed USA 0
NCT04211337 Phase III Vandetanib Cabozantinib Selpercatinib A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) Recruiting USA | CAN 19
NCT01588821 Phase II Cabozantinib Cabozantinib in Advanced Solid Malignancies Completed USA 0
NCT04412629 Phase II Cabozantinib Cabozantinib in High Grade Neuroendocrine Neoplasms Recruiting USA 0
NCT01811212 Phase II Cabozantinib Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer Completed USA 0
NCT02551718 Phase I Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia Active, not recruiting USA 0
NCT03541902 Phase II Cabozantinib Sunitinib Cabozantinib Versus Sunitinib for Metastatic Variant Histology Renal Cell Carcinoma Recruiting USA 0
NCT01865747 Phase III Everolimus Cabozantinib A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma Completed USA | CAN 24
NCT02036476 Phase II Cabozantinib Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma Active, not recruiting USA 0
NCT01639508 Phase II Cabozantinib Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity Recruiting USA 0
NCT04310007 Phase II Nab-paclitaxel Gemcitabine Cabozantinib + Nivolumab Cabozantinib Docetaxel Paclitaxel Docetaxel + Ramucirumab Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer Recruiting USA 0
NCT05012371 Phase II Cabozantinib Everolimus + Lenvatinib Lenvatinib With Everolimus Versus Cabozantinib for Second-Line Treatment of Metastatic Renal Cell Cancer Not yet recruiting USA 0
NCT04511455 Phase II Cabozantinib A Phase II, Non-randomized, Single Arm, Translational Study of Cabozantinib for Patients With Hepatocellular Carcinoma (HCC) Refractory to Lenvatinib Treatment Recruiting 1
NCT03375320 Phase III Cabozantinib Cabozantinib S-malate in Treating Patients With Neuroendocrine Tumors Previously Treated With Everolimus That Are Locally Advanced, Metastatic, or Cannot Be Removed by Surgery Recruiting USA 0
NCT03428217 Phase II Cabozantinib Cabozantinib + Telaglenastat CB-839 With Cabozantinib vs. Placebo With Cabozantinib in Patients With Metastatic Renal Cell Carcinoma (CANTATA) Completed USA 7
NCT01812668 Phase I Cabozantinib Cabozantinib-S-Malate in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer Completed USA 0
NCT04435977 Phase II Cabozantinib Efficacy and Safety of Cabozantinib in Patients With Hepatocellular Carcinoma (Immunocabo) Recruiting 1
NCT01822522 Phase I Cabozantinib Cabozantinib-S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus Active, not recruiting USA 0
NCT01896479 FDA approved Cabozantinib A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer Active, not recruiting CAN 13
NCT03964337 Phase II Cabozantinib Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer (SPARC) Recruiting USA 0
NCT04522908 Phase II Cabozantinib Dose Escalation Study of Cabozantinib for Advanced HCC Patients With Compensated Liver Cirrhosis Recruiting 1
NCT01630590 Phase II Cabozantinib Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer Completed USA 0
NCT02260531 Phase II Cabozantinib Trastuzumab Cabozantinib + / - Trastuzumab In Breast Cancer Patients w/ Brain Metastases Completed USA 0
NCT04022343 Phase II Cabozantinib Neoadjuvant Cabozantinib in Treating Patients With Locally Advanced Kidney Cancer Recruiting USA 0
NCT02867592 Phase II Cabozantinib Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors Active, not recruiting USA 0
NCT04586231 Phase III Belzutifan + Lenvatinib Cabozantinib A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011) Recruiting USA 12
NCT01755195 Phase II Cabozantinib Cabozantinib for Adults With Advanced Soft Tissue Sarcoma Active, not recruiting USA 0
NCT03542877 Phase II Cabozantinib Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer Active, not recruiting USA 0
NCT04204850 Phase II Cabozantinib Cabozantinib to Treat of Recurrent Liver Cancer Post Transplant (CaboTx) Recruiting CAN 0
NCT04631744 Phase II Cabozantinib Cabozantinib in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Recruiting USA 0
NCT01961765 Phase I Cabozantinib Phase I Trial of Cabozantinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia Completed USA 0
NCT04316182 Phase II Cabozantinib Cabozantinib in Patients With Hepatocellular Carcinoma (ACTION) (ACTION) Recruiting 1
NCT03690388 Phase III Cabozantinib A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-targeted Therapy Active, not recruiting USA | CAN 23
NCT04071223 Phase II Cabozantinib + Radium Ra 223 dichloride Cabozantinib Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, the RadiCaL Study Recruiting USA 0
NCT04066595 Phase II Cabozantinib Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma. (CabUC) Terminated 1
NCT04454762 Phase II Cabozantinib A Study to Evaluate the Safety, Tolerability and Efficacy of Cabozantinib in Patients With Hepatocellular Carcinoma and Impaired Liver Function (CaboCHILD) Recruiting 1


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