Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Disease Progression

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants with advanced endometrial cancer and disease progression following platinum-based, first line chemotherapy.

Lenvatinib 24 mg administered orally, once daily continuously in 28-day cycles to participants with advanced endometrial cancer and disease progression following first-line chemotherapy. Participants continued to receive study drug until disease progression, development of unacceptable toxicity or withdrawal of consent. 'Treatment interruption and subsequent dose reduction' was allowed for participants who experienced lenvatinib-related toxicity.

Eisai Medical Services

To assess the objective response rate (ORR: complete response + partial response \[CR+ PR\]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy. .

Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression

An Open-Label, Single-Arm, Multicenter Phase II Study of E7080 (Lenvatinib) in Subjects With Advanced Endometrial Cancer and Disease Progression Following First-Line Chemotherapy

A total of 6 blood samples for pharmacokinetic (PK) analysis were collected from each participant who received lenvatinib once daily.

The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of 2 dynamic contrast-enhanced magnetic resonance imaging/diffusion-weighted magnetic resonance imaging (DCE-MRI/DWI MRI) scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included percentage change in initial area under the gadolinium contrast agent time-concentration curve (first 90 seconds, blood normalized) from baseline.

The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in Ktrans for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.

The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in ADC for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.

ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review. BOR of CR was confirmed by a subsequent CR assessment at least 4 weeks later. BOR of PR was confirmed by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. The null hypothesis ORR was ≤10% was tested using 1-sided exact test of a single proportion, at 1-sided 0.05 level. ORR was presented with corresponding 2-sided, 95% confidence interval (CI). ORR=CR+PR

PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death (whichever occurred first), as determined by independent radiologic review (IRR) and Investigator based on RECIST 1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.

OS was the length time in months from the date of first treatment until the date of death from any cause. If death was not observed, OS was censored at the last known alive date or data cut-off. Additional survival follow-up data was collected for all participants who had not withdrawn consent and were alive at the time of the initial survival follow-up as of 26 Nov 2012 data cut-off. Participants who were lost to follow-up at the time of the initial assessment may have been contacted again at the investigator's discretion. Updated survival (based on 26 Nov 2012 cut-off) was derived for these participants if the contact was made successfully.

DCR was defined as the percentage of participants with BOR of CR or PR or stable disease (SD) based on RECIST 1.1 and SD lasting greater than or equal to 7 weeks, as determined by IRR and Investigator.

CBR was defined as the percentage of participants with BOR of CR or PR or durable stable disease (dSD) \[CR + PR + dSD\] based on RECIST 1.1. The dSD rate was defined as the percentage of participants with dSD (based on RECIST 1.1 and defined as SD lasting greater than or equal to 23 weeks), as determined by the IRR and Investigator.

Safety was assessed by monitoring and recording all AEs and SAEs, regular monitoring of hematology, clinical chemistry, and urine values, regular measurement of vital signs, electrocardiograms (ECGs), and echocardiograms.

Eisai Inc.

Treatment-emergent adverse events (TEAEs) and serious TEAEs were collected and reported. Safety analysis set included all participants who received at least one dose of study drug. AEs were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles

Lenvatinib 24 mg

Age, Continuous

Sex: Female, Male

Carboplatin

Cisplatin

Cisplatin w/Doxorubicin

Taxol [Paclitaxel] w/Carboplatin

Participants could have received more than one prior platinum based chemotherapy regimen.

Prior Platinum-based Chemotherapy Regimen

Full Analysis Set (Intent-to-Treat \[ITT\] Analysis Set) was used and included all participants who received at least 1 dose lenvatinib.

Objective Response Rate (ORR)

Determined by IRR

Determined by Investigator

Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.

Progression Free Survival (PFS)

Overall Survival (OS)

Disease Control Rate (DCR)

Clinical Benefit Rate (CBR)

SAEs

Safety Analysis Set included all participants who received at least 1 dose of lenvatinib and had at least 1 postbaseline safety evaluation. This was the analysis set for all safety evaluations.

Number of Participants With Adverse Events (AEs) /Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib Tolerability of Lenvatinib

Cycle 1, Day 1 (Pre-dose) n=132

Cycle 1, Day 1 (2-hour Post-dose) n=132

Cycle 1, Day 8 (Pre-dose) n=122

Cycle 1, Day 8 (2-hour Post-dose) n=123

Cycle 2, Day 1 (Pre-dose) n=107

Cycle 2, Day 1 (2-hour Post-dose) n=102

PK analysis set was used and included all participants with an evaluable plasma concentration.

Summary of Plasma Concentration of Lenvatinib

Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.

Percentage Change From Baseline for the Imaging Biomarker Parameter of the Area Under the Plasma Concentration Curve Blood Normalized (90) (AUCBN (90)) Median for Total Volume

Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.

Percentage Change From Baseline in the Contrast Volume Transfer Coefficient (Ktrans) Median

Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 2 participants with evaluable data.

Percentage Change From Baseline in the Apparent Diffusion Coefficient (ADC) Median

Lenvatinib hard capsules, 24 mg (two 10-mg capsules and one 4-mg capsule) were self-administered orally once a day in the morning (without regard to food intake) in 28-day cycles. Dose reduction or interruption was allowed for participants who experienced lenvatinib-related toxicity.

Overall Study

Pharmaceutical Solutions

Natriuretic Agents

Gastrointestinal Agents

Bone Density Conservation Agents

Central Nervous System Depressants

Other Dietary Supplements

Pembrolizumab

Calcium

Mannitol

Calcium Carbonate

Calcium, Dietary

Benzocaine

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Tannic Acid

3 to 6 patients will receive EG-007 1000 mg once weekly starting on the day of injection of Pembrolizimab starting the next 21-day cycle of treatment.

6 to 10 patients will receive EG-007 loading dose of 5000 mg given as 1000 mg daily over 5 consecutive days starting 4 days before the first dose of Pembrolizumab under this protocol.

6 to 12 patients initiating new regimens of Len+Pem will receive EG-007 loading dose of 5000 mg given as 1000 mg daily over 5 consecutive days starting 4 days before the first dose of Pembrolizumab.

EG-007

Pembrolizumab will be provided as a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution that requires dilution for intravenous infusion. Each vial contains 100 mg of pembrolizumab in 4 mL of solution.

Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection

Lenvatinib will be provided as 4-mg and 10-mg capsules. Lenvatinib is formulated with calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropylcellulose, and talc.

Lenvatinib Capsules

Xin Du, Ph.D.

Charles Lee, M.D., Ph.D.

This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.

A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.

Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem

A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab

Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTCAE v5.0, toxicities will be characterized in terms including seriousness, causality, toxicity grading, and action taken with regard to trial treatment. Data Monitoring committee review for safety to proceed through dose escalation.

Using NCI-PRO CTCAE to record the tolerability score for patients to evaluate symptomatic toxicities.

To conduct long-term monitoring of the safety and clinical outcomes for EG-007 plus Len+Pem. The proportion of Participants With Treatment-Related Adverse Events during long-term monitoring.

Evergreen Therapeutics, Inc.

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Uterine Sarcoma

Anti-Infective Agents

Amino Acids

Gemcitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Antibodies

Antibodies, Monoclonal

Doxorubicin

Liposomal doxorubicin

Immunoglobulins

Tyrosine Kinase Inhibitors

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Tyrosine

First-line treatment: TQB2450 injection 1200mg,d1/Q3W+Carboplatin Injection, AUC=5 mg/ml.min,d1/Q3W + Paclitaxel Injection 175mg/m2,d1/Q3W;6-8 cycles;

Maintenance treatment: TQB2450 injection, 1200mg，d1/Q3W

First-line treatment: TQB2450 Injection 1200mg, d1/Q3W + Anlotinib Hydrochloride Capsules 8mg/qd, d8-21/Q3W + Carboplatin Injection AUC=5 mg/ml.min, d1/Q3W + Paclitaxel Injection 175mg/m2, d1/Q3W ; 6-8 cycles; Maintenance treatment: TQB2450 injection+ Anlotinib Hydrochloride Capsules 8mg/qd, d8-21/Q3W

First-line treatment stage:

TQB2450 injection 1200mg, d1/Q3W + anlotinib hydrochloride capsules 8mg/qd, d8-21/Q3W+ chemotherapy（① Doxorubicin Hydrochloride Injection 60mg/㎡，d1/Q3W; or ② Gemcitabine Hydrochloride Injection 900mg/㎡, d1, d8/Q3W+ Docetaxel Injection 75mg/㎡, d8/Q3W）; 6-8 cycles;

Maintenance phase:

TQB2450 injection 1200mg, d1/Q3W+ Anlotinib hydrochloride capsules 10mg/qd, d8-21/Q3W

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents the binding of PD-L1 to PD-1 and B7.1 receptors on the surface of T cells, thereby reactivating T cells and enhancing the immune response.

TQB2450 injection

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Anlotinib Hydrochloride Capsule

Carboplatin which s similar to alkylating agent, is a second-generation platinum anti-tumor drug, which mainly causes cross-linking of DNA within and between chains, destroys DNA molecules, and disintegrates the helix.

Carboplatin Injection

Paclitaxel is a diterpene alkaloid with anticancer activity

Paclitaxel Injection

Doxorubicin hydrochloride is a cycle non-specific anticancer chemotherapy drug, which directly acts on DNA, changes the nature of DNA template, and inhibits DNA polymerase.

Doxorubicin Hydrochloride Injection

Gemcitabine is a cell cycle specific antimetabolic drug, which mainly acts on tumor cells at the DNA synthesis stage.

Gemcitabine Hydrochloride Injection

Docetaxel is an anti-tumor drug of paclitaxel, which plays an anti-tumor role by interfering with the microtubule network necessary for cell Mitosis and interphase cell function.

Docetaxel injection

Xiaojun Chen, Doctor

Ke Wang, Doctor

Dapeng Li

Ruifang An

Hui Qiu, Doctor

Keqiang Zhang, Doctor

Hua Qian, Doctor

Yongjie Zhang, Doctor

Ying Yang, Doctor

Bingzhong Zhang, Doctor

Xiumin Li, Doctor

Chunyan Wang, Doctor

This study plans to enroll 69 subjects of endometrial cancer and 5-10 subjects of sarcoma of uterus. The experimental set is divided into lead-in trial and formal trial. The lead-in trial includes 9 subjects to observe the safety of the combination and determine the dosage of anlotinib dihydrochloride capsules before the formal phase.

The formal trial includes 60 subjects of endometrial cancer and 5-10 subjects of sarcoma of uterus. The purpose is to evaluate efficacy and safety of TQB2450 injection combined with chemotherapy ± anlotinib hydrochloride capsules for first-line treatment and maintenance treatment of patient with advanced endometrial cancer or sarcoma of uterus, and explore biomarkers related to efficacy, mechanism of action, safety and/or pathological mechanisms, the surgical conversion rate. ORR is the primary endpoint.

Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.

Evaluating the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for First-line Treatment of Patient With Advanced Endometrial Cancer or Sarcoma of Uterus: a Multi-center, Open-label, Randomized Controlled, Phase II Clinical Trial.

The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases with complete remission and partial remission

From randomization to the first occurrence of disease progression or death from any cause. Disease progression refers to tumor growth, or the metastasis of primary tumor lesions, or the discovery of new lesions, etc.

From randomization to the time of death of death from any cause

The period from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD).

the proportion of patients whose tumors shrink or remain stable for a certain period of time, including complete remission (CR, Complete Response), partial remission (PR, Partial Response) and stable (SD, stable Disease) cases

The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

The incidence of abnormal laboratory test indicators of participants by attachment 1 in the test protocol.

The proportion of subjects who meet the criteria and undergo radical resection surgery.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Carcinoma

BKM120

Novartis Pharmaceuticals

This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

BKM120 as Second-line Therapy for Advanced Endometrial Cancer

A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma

BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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

PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Overall survival (OS) was defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months

All Patients

Female

Male

Sex/Gender, Customized

Study Director

Patients with Measurable disease at baseline

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive disease (PD)

Unknown (UNK)

Overall Response Rate (CR + PR)

Activated Pl3K

Non-Activated Pl3K

Full analysis set includes all patients who received at least one dose of study drug.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression	NCT01111461	Endometrial Can...	Lenvatinib	18 Years -	Eisai Inc.
Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem	NCT05106127	Advanced Endome...	EG-007 Pembrolizumab 1... Lenvatinib Caps...	18 Years -	Evergreen Therapeutics, Inc.
Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression	NCT01111461	Endometrial Can...	Lenvatinib	18 Years -	Eisai Inc.
Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.	NCT05481645	Advanced Endome... Sarcoma of Uter...	TQB2450 injecti... Anlotinib Hydro... Carboplatin Inj... Paclitaxel Inje... Doxorubicin Hyd... Gemcitabine Hyd... Docetaxel injec...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
BKM120 as Second-line Therapy for Advanced Endometrial Cancer	NCT01289041	Advanced Endome...	BKM120	18 Years -	Novartis
Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.	NCT05481645	Advanced Endome... Sarcoma of Uter...	TQB2450 injecti... Anlotinib Hydro... Carboplatin Inj... Paclitaxel Inje... Doxorubicin Hyd... Gemcitabine Hyd... Docetaxel injec...	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Efficacy and Safety of a Repurposed Drug Added to the Combination of Len Plus Pem in Advanced Endometrial Cancer	NCT05077215	Advanced Endome...	EG-007 Pembrolizumab 1... Lenvatinib Caps...	18 Years -	Evergreen Therapeutics, Inc.
GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer	NCT06046274	Advanced Endome...	Pembrolizumab Acasunlimab	18 Years -	Genmab
Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem	NCT05106127	Advanced Endome...	EG-007 Pembrolizumab 1... Lenvatinib Caps...	18 Years -	Evergreen Therapeutics, Inc.
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer	NCT04574284	Advanced Endome...	TQB2450 Anlotinib	18 Years -	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for advanced endometrial cancer