Gastrointestinal Stromal Tumors Clinical Trial
Official title:
Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial
Gastrointestinal stromal tumors (GIST) compose approximately 20% of soft tissue sarcomas with
an annual incidence of approximately 7 per million population. GISTs occur throughout the GI
tract, most commonly in the stomach or small intestine. The main treatment for localised GIST
is surgical resection. At least 40% of these patients will develop recurrence or metastasis
following complete resection. Local recurrence, liver metastases and/or dissemination within
the abdominal cavity are the most common clinical manifestations. Although imatinib and
sunitinib has greatly improved the quality of life and survival of patients with advanced
GIST. Analysis of clinical trials revealed that patients with tumours with KIT exon 17 or 18
mutations, with a second mutation in KIT exon 17 or 18, had worse responses to imatinib and
sunitinib. Some patients with PDGFRA D842V mutation do not respond to the present standard
therapies.
Anlotinib (1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinolin-7-Yl] oxy]
methyl]cyclopropanamine dihydrochloride) , a multi-targeted tyrosine kinase inhibitor (TKI),
characterized as a highly selective and potent c-KIT, VEGFR, PDGFR, FGFR inhibitor. In vitro
and in vivo, Anlotinib has a broad spectrum of inhibitory action on tumor angiogenesis and
growth, which showed broad activity against soft tissue sarcoma and GIST with D842V, D816H,
V560G and V654A mutations. In 2015, the US FDA granted orphan drug treatment for ovarian
cancer.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05385549 -
5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk
|
Phase 2 | |
| Recruiting |
NCT05905887 -
Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor
|
Phase 2 | |
| Completed |
NCT01933958 -
Regorafenib Post-marketing Surveillance in Japan
|
||
| Recruiting |
NCT04584008 -
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
|
N/A | |
| Completed |
NCT01440959 -
Dovitinib for Imatinib/Sumitinib-failed Gastrointestinal Stromal Tumors (GIST): TKI258
|
Phase 2 | |
| Completed |
NCT00718562 -
Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib
|
Phase 2 | |
| Completed |
NCT00385203 -
The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
|
Phase 2 | |
| Completed |
NCT00137449 -
Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor
|
Phase 2 | |
| Completed |
NCT00237172 -
Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)
|
Phase 2 | |
| Terminated |
NCT04409223 -
Efficacy and Safety of Famitinib Versus Sunitinib in the Treatment of Advanced Gastrointestinal Stromal Tumour Patients After Failure of Imatinib
|
Phase 3 | |
| Active, not recruiting |
NCT03556384 -
Temozolomide (TMZ) In Advanced Succinate Dehydrogenase (SDH)-Mutant/Deficient Gastrointestinal Stromal Tumor (GIST)
|
Phase 2 | |
| Completed |
NCT02171286 -
The Oncopanel Pilot (TOP) Study
|
N/A | |
| Completed |
NCT01114087 -
Impact of the Inhibitors of Tyrosine Kinase on the Male Fertility
|
N/A | |
| Recruiting |
NCT05366816 -
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
|
Phase 2 | |
| Recruiting |
NCT03602092 -
Observational Registry Data on GIST Patients
|
||
| Recruiting |
NCT05197933 -
Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach
|
N/A | |
| Completed |
NCT02931929 -
MITIGATE-NeoBOM: A Study to Evaluate 68Ga- NeoBOMB1 in Patients With Advanced TKI-treated GIST Using PET/CT
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05080621 -
Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)
|
Phase 1/Phase 2 | |
| Completed |
NCT02638766 -
Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST
|
Phase 2 | |
| Completed |
NCT02571036 -
A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies
|
Phase 1 |