Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Endometrial Neoplasms

Genital Diseases, Female

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status

TKI258

Novartis Pharmaceuticals

This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.

A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

A Phase II, Open-label, Single-arm, Non-randomized, Multi-center Study to Evaluate the Efficacy of Oral TKI258 as Second-line Therapy in Patients With Either FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).

DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).

Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.

OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.

PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.

Adverse event monitoring was conducted throughout the study.

Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.

FGFR2 (MUT)

FGFR2 (WT)

Total

Age, Continuous

Sex/Gender, Customized

Study Director

Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.

Progression Free Survival (PFS) Rate

Overall Response Rate (ORR)

Disease Control Rate (DCR)

This outcome measure was not analyzed. The analysis was not required because there were too few responders.

Duration of Response (DR)

Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.

Overall Survival (OS)

Progression Free Survival (PFS)

Adverse events (serious and non-serious)

Serious adverse events

Deaths

Safety analysis set: The safety set included all participants who received at least one dose of study medication.

Number of Participants With Adverse Events, Serious Adverse Events and Deaths

Treatment Phase

Tumor Assessment Follow-up (f/u) Phase

Antineoplastic Agents

All Drugs and Chemicals

Dactolisib

BEZ235

This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.

BEZ235 Trial in Patients With Advanced Endometrial Carcinoma

A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma

Blood and Lymph Conditions

Hematologic Neoplasms

Herbal and Botanical

Cola

LDE225 800 mg (hard gelatin capsules) will be administered orally once daily on a continuous dosing schedule.

LDE225 800 mg (hard gelatin capsules) will be administered orally once daily on a continuous dosing schedule

LDE225

The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study

LDE225 for Patients With PTCH1 or SMO Mutated Tumors

Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module - 5 LDE225 for Patients With PTCH1 or SMO Mutated Tumors

Clinical benefit rate (CBR) Number and percentage of subjects with CBR (responses of CR, PR or SD ≥ 16 weeks) as assessed by investigator was reported for all patients along with 95% exact confidence interval (CI). Overall Response Rate (ORR) Overall response was to be determined by investigator assessment for each tumor in the study. For subjects with solid tumors, the assessment criteria was RECIST 1.1 and included responses of CR and/or PR. The number and percentage of subjects for different categories of overall response (e.g., for solid tumors - CR, PR, SD, PD, Not Evaluable) were to be provided for solid tumors, and each hematological tumor type (if applicable). Ninety-five percent (95%) exact CI was to be provided for the response rate(s) (e.g., for solid tumors - CRn and/or PR) as well.

Progression-free survival (PFS) is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 30 days of last dose. If a subject has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.

All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.

Sonidegib

Age, Categorical

Sex: Female, Male

The study was closed for accrual when the sponsor realized that not enough patients will be recruited for any meaningful stat analysis even if the study were kept open beyond the original planned accrual window.

Clinical Disclosure Office

Complete response (CR)

Partial response (PR)

Stable disease (SD)

Progressive disease (PD)

Non-evaluable (NE)

Overall response rate (ORR: CR+PR)

Clinical benefit rate (CBR: CR+PR+SD)

Summary of Overall Response (ORR) and Clinical Benefit (CBR)

1 Month

2 Months

3 Months

4 Months

Summary of Timing and Estimated Rate for Progression-free Survival (PFS) - Full Analysis Set

Kaplan-Meier Estimates of Progression Free Survival (PFS )Timing, Months

Overall Study

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Breast Neoplasms

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

The Success Study's Standard Behavioral Weight Change Intervention consists of 75 minute group sessions held monthly which include 30 minutes of physical activity with a licensed Physical Activity Instructor. Web Lessons that include information on Physical Activity, Nutrition and Healthy Behaviors will also be provided to participants on the study's website.

Participants enrolled in Phase 2 of the study will meet once a month for 75 minutes over the course of 4 months. Within this 75 minutes, they will complete 25 minutes of physical activity with a licensed physical activity instructor that is very experienced with working with this population, review and discuss various topics/lessons that relate to diabetes, nutrition, survivorship and physical activity with the study's interventionist and Group Leader

Standard Behavioral Weight Change Intervention

Wanda Nicholson, MD

Investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African American female breast or endometrial cancer survivors diagnosed with type 2 diabetes.

Recent systematic reviews and meta-analyses of cohort studies show that physical activity can reduce mortality and morbidity in diabetes and obesity-related cancers. Yet, there have been few efforts to promote physical activity within the context of female cancer survivorship, particularly among women with diabetes. In response, investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African Americans (AA) with diabetes and who are breast or endometrial cancer survivors. This web-based, lifestyle intervention, coupled with coaching calls and in-person exercise sessions, may be an effective way to promote physical activity and healthy survivorship. The primary goal is for participants to participate in 30 minutes of moderate-to-vigorous physical activity five times a week. The investigators' aims : i) refine a theory-driven healthy lifestyle intervention, that is delivered via computer technologies and periodic in-person group exercise sessions with appropriate content, literacy demand and graphics, ii) assess the preliminary effects of the intervention on the primary outcome of level of moderate to vigorous physical activity (MVPA), as measured by accelerometry; weight, glycosylated hemaglobin and evaluate the effect of eating behaviors, wellbeing/functioning (quality of life, depressive symptoms, self-efficacy), compliance/adherence to protocol and acceptability on response to the intervention.

Translating Healthy Lifestyle Interventions for Cancer Survivors

Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes

Body weight in pounds will be measured on a digital scale to assess change in body weight over the 16-week intervention period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer	NCT01379534	Solid Tumors an... Endometrial Can... Second-line Tre... VEGF	TKI258	18 Years -	Novartis
BEZ235 Trial in Patients With Advanced Endometrial Carcinoma	NCT01290406	Endometrial Can...	BEZ235	18 Years -	Novartis
LDE225 for Patients With PTCH1 or SMO Mutated Tumors	NCT02002689	PTCH1 or SMO Ac...	LDE225	18 Years -	Novartis
LDE225 for Patients With PTCH1 or SMO Mutated Tumors	NCT02002689	PTCH1 or SMO Ac...	LDE225	18 Years -	Novartis
BEZ235 Trial in Patients With Advanced Endometrial Carcinoma	NCT01290406	Endometrial Can...	BEZ235	18 Years -	Novartis
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer	NCT01379534	Solid Tumors an... Endometrial Can... Second-line Tre... VEGF	TKI258	18 Years -	Novartis
Translating Healthy Lifestyle Interventions for Cancer Survivors	NCT02690766	Diabetes Mellit... Breast Cancer Endometrial Can...	Standard Behavi...	30 Years - 99 Years	University of North Carolina, Chapel Hill

Spots Global Cancer Trial Database for endometrial cancer,