Ribociclib for Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Carcinoma+17 More
Ribociclib - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This study is evaluating whether a combination of drugs may help treat endometrial cancer.

See full description

Eligible Conditions

  • Carcinoma
  • Recurrent Endometrial Carcinoma
  • Stage IIIA Uterine Corpus Cancer AJCC v8
  • Stage IIIC1 Uterine Corpus Cancer AJCC v8
  • Refractory Endometrial Carcinoma
  • Recurrent Endometrial Endometrioid Adenocarcinoma
  • Stage IV Uterine Corpus Cancer AJCC v8
  • Stage III Uterine Corpus Cancer AJCC v8
  • Refractory Endometrial Endometrioid Adenocarcinoma
  • Stage IIIC Uterine Corpus Cancer AJCC v8
  • Stage IIIB Uterine Corpus Cancer AJCC v8
  • Stage IVB Uterine Corpus Cancer AJCC v8
  • Stage IVA Uterine Corpus Cancer AJCC v8
  • Stage IIIC2 Uterine Corpus Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Ribociclib will improve 1 primary outcome in patients with Carcinoma. Measurement will happen over the course of At 8 weeks.

At 8 weeks
Clinical benefit rate (CBR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm I (ribociclib, everolimus, letrozole)
1 of 2
Arm II (everolimus, letrozole)
1 of 2
Experimental Treatment

This trial requires 87 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ribociclib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm I (ribociclib, everolimus, letrozole)Patients receive ribociclib PO QD, everolimus PO QD, and letrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II (everolimus, letrozole)Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved
Ribociclib
FDA approved
Everolimus
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 8 weeks for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Carcinoma or one of the other 17 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must stop taking any other anti-cancer therapies (including immunotherapy) for at least four weeks before enrolling in the study show original
The patients must not have had more than two previous chemotherapeutic treatments for recurrent endometrial carcinoma show original
All patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 defined as at least one "target lesion" that can be accurately measured in at least one dimension (>= 10 mm longest dimension to be recorded; Lymph nodes must be >= 15 mm per short axis). Each lesion must be > 20 mm when measured by palpation or conventional imaging techniques (computed tomography [CT] or magnetic resonance imaging [MRI] - based on primary physician preference) or > 10 mm with spiral CT scan. Measurable lesions must be at least 2 times the slice thickness in millimeters. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented. Ascites and pleural effusions are not considered measurable disease. If the measurable disease is confined to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
Patients must not be pregnant, breastfeeding or of child-bearing potential. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a total hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal for greater than 12 months (if patient is uncertain of amenorrhea for 12 months, a pregnancy test will be done to confirm pregnancy status). Patients in whom ovaries are present and were not previously menopausal at the time of hysterectomy, should have a serum estradiol < 10 pm/mL to confirm ovarian senescence.
The patient has consented to the screening procedures and is able to comply with the protocol requirements. show original
1.) Patients must have a confirmed diagnosis of endometrial cancer show original
This means that the patient's cancer has come back after treatment or has not responded to treatment. show original
Patient must consent to allow for a baseline tumor biopsy. Tumor material from biopsies done before the screening period are acceptable if the biopsy was performed within 3 months prior to the planned treatment start and no other systemic cancer therapy was administered in the interim. If a biopsy is performed and the specimen is considered non-diagnostic, does not have enough tissue, or the biopsy is deemed infeasible to perform, this does not prevent the patient from proceeding with the treatment
You are allowed to have any kind of radiation therapy done before you join this study. show original
If the patient has previously taken letrozole, they must wait 10 days before taking Aromasin. show original

Patient Q&A Section

How many people get carcinoma, endometrioid a year in the United States?

"Around 2 cases of endometrioid carcinoma are diagnosed in the United States every 100 000 people a year. As of 2009, around 4 % of all endometrioid carcinomas were caused by the Epstein-Barr virus.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, endometrioid?

"Treatment of endometrioid cancer requires surgical removal and lymph node debulking. Chemotherapy options include carboplatinum and taxanes. Radiation therapy, preferably to the pelvis, is the cornerstone of treatment of carcinoma, endometrioid. However, a small number of patients will respond and be durable responders." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, endometrioid?

"In the past, it was thought that carcinoma, endometrioid, is a form of low-grade or endometrioid endometrial cancer. However, it is not, nor is it always present. Its histopathologic features are more akin to serous carcinomas. The tumour has a good prognosis. But it arises more commonly in postmenopausal women and younger women who are hormonally active. The tumour occurs in an endometrial polyp which is itself a type of hyperplasia. It appears to have undergone neoplastic evolution in the endometrial cells. Thus, the pathogenesis is complex." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, endometrioid?

"Carcinoma, endometrioid, with vaginal involvement has clear signs. Tumor size and nodal and distant metastatic spread are important factors in predicting the survival of patients." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, endometrioid be cured?

"Cancer, endometrioid type, shows a pattern similar to endometrioid adenocarcinoma of the ovarian stroma. Both, therefore, may be treated with a radical surgery. On the basis of this report, there may be no benefit to adjuvant radiotherapy." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, endometrioid?

"The cause of carcinoma, endometrioid is unknown, but may be a result of a combination of factors which present during development. These includes genetics, brain injury, and exposure to certain toxins during pregnancy. These factors may be similar to those involved in the causation of ovarian cancer." - Anonymous Online Contributor

Unverified Answer

Has ribociclib proven to be more effective than a placebo?

"Ribocylcis does not increase the efficacy of letrozole over placebo in patients with advanced hormone-responsive breast cancer. No difference in the incidence of adverse effects was observed between the two groups." - Anonymous Online Contributor

Unverified Answer

Is ribociclib typically used in combination with any other treatments?

"Ribociclib was most commonly used in combination with any other agents in clinical trials of BRCA-deficient advanced or metastatic BRCA-mutated cancer. Results from a recent clinical trial can be applied to any BRCA-mutated cancer and might help guide clinical design." - Anonymous Online Contributor

Unverified Answer

Is ribociclib safe for people?

"Ribociclib is typically well tolerated with no evidence of treatment-related harm over three cycles of treatment. Patients should be aware that increased incidence of high blood calcium may be associated with ribociclib treatment." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, endometrioid?

"Given the excellent survival outcomes after primary therapy and the modest survival after second-line therapy and the high rate of systemic therapy failure in primary and secondary disease, patients with endometrioid should have a high likelihood of survival and might be more likely to tolerate the adverse events associated with systemic therapies and be able to benefit from treatment." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma, endometrioid?

"There are 3 major causes of carcinoma endometrioid that can be attributed to, the causes include a hereditary pattern, inflammation caused by infectious agents, or carcinogenesis." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, endometrioid?

"The survival rate for carcinoma, endometrioid was 66.4%. If the stage of carcinoma, endometrioid is early stage, it has high survival rate. If the stage is middle or late stage, the survival rate is relatively low." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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