Abemaciclib for Urinary Bladder Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Moffitt Cancer Center, Tampa, FL
Urinary Bladder Cancer+1 More
Abemaciclib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Urinary Bladder Cancer

Study Summary

This study is evaluating whether a drug may help treat bladder cancer.

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Eligible Conditions

  • Urinary Bladder Cancer
  • Urinary Bladder Neoplasms
  • Bladder Cancer, Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Abemaciclib will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Urinary Bladder Cancer. Measurement will happen over the course of At baseline and post 4 week treatment.

Week 4
Change in cell-cycle dynamics between pre- and post-Abemaciclib tumor samples
Effect on tumor downstaging defined as <pT2 at time of cystectomy
Year 3
Incidence of Treatment-Emergent Adverse Events (TEAEs) of Abemaciclib
Year 3
Impact of Abemaciclib on clonal evolution

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Side Effects for

Abemaciclib
Diarrhoea
91%
Nausea
67%
Fatigue
48%
Decreased appetite
45%
Vomiting
35%
Anaemia
27%
Abdominal pain
26%
Asthenia
23%
Neutrophil count decreased
23%
Cough
21%
Constipation
20%
Headache
20%
Arthralgia
19%
White blood cell count decreased
18%
Neutropenia
18%
Alopecia
15%
Dry mouth
14%
Dysgeusia
14%
Platelet count decreased
14%
Weight decreased
14%
Dyspnoea
13%
Back pain
12%
Dizziness
12%
Abdominal pain upper
12%
Pyrexia
11%
Blood creatinine increased
11%
Oedema peripheral
11%
Dyspepsia
11%
Pain
10%
Stomatitis
9%
Aspartate aminotransferase increased
9%
Thrombocytopenia
8%
Lacrimation increased
8%
Pruritus
8%
Dry skin
8%
Dehydration
8%
Alanine aminotransferase increased
8%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
7%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
6%
Gastrooesophageal reflux disease
5%
Myalgia
5%
Rash
5%
Cellulitis
2%
Pleural effusion
2%
Arterial thrombosis
1%
Renal function test abnormal
1%
Pulmonary embolism
1%
Sepsis
1%
Liver function test abnormal
1%
Lung infection
1%
Sinus bradycardia
1%
Respiratory tract infection
1%
Hip fracture
1%
Fall
1%
Pneumothorax
1%
Gastroenteritis viral
1%
Large intestinal obstruction
1%
Tachycardia
1%
Haematotoxicity
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Muscular weakness
1%
Bone pain
1%
Acute kidney injury
1%
Febrile neutropenia
1%
Pancreatic enzyme abnormality
1%
Atypical pneumonia
1%
Pneumonitis
1%
Epilepsy
1%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02102490) in the Abemaciclib ARM group. Side effects include: Diarrhoea with 91%, Nausea with 67%, Fatigue with 48%, Decreased appetite with 45%, Vomiting with 35%.

Trial Design

2 Treatment Groups

Control
All Subjects

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Abemaciclib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

All Subjects
Drug
Abemaciclib 200 mg oral, every 12 hours
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

Moffitt Cancer Center - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Neuropathy ≥ grade 2 by CTCAE criteria and/or a. Absolute neutrophil count ≥ 1.5 K/mm3 b. White blood cell count (WBC) > 3.0 K/mm3 c. Platelets ≥ 100 K/mm3 d. Hemoglobin ≥ 9 g/dL e. Serum total bilirubin ≤ 1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted) f. ALT and AST ≤ 2.5 x ULN g. Serum creatinine clearance (CrCl) ≥ 30 ml/min using the MDRD or serum creatinine ≤ 2 times ULN.using the Cockcroft-Gault or measurement with 24 hour urine collection 6. Ability to swallow oral medications 7. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization
1. Age ≥ 18 years old at time of informed consent 2. Histologically confirmed MIBC (T2-T4) pure or mixed histology urothelial carcinoma [urothelial carcinoma should be the dominant (>50%) histology].
Creatinine clearance < 60 mL/min (by Cockgroft-Gault calculation and/or measured creatinine clearance)
Hearing loss ≥ grade 2 by CTCAE criteria and/or;

Patient Q&A Section

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

What is urinary bladder cancer?

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There are many rare cancers that can present with urinary tract symptoms like hesitancy to urinate, pain, bladder outflow obstruction, or frequency. The presence of palpable masses on a bladder cystoscopy should prompt surgeons to exclude other bladder pathology.

Unverified Answer

Can urinary bladder cancer be cured?

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Treatment for urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) is currently dependent on the stage of the cancer, as well as the patient's overall health. There is currently no cure for urinary bladder cancer, therefore, treatments are focused on managing pain, as well as delaying the cancer further until the treatment of the cancer is not essential anymore. Because of the different treatments available to manage symptom relief, there is a wide range of treatments for pain management at the bedside. These treatments include intravesical instillations of chemotherapy and the use of alpha blockers. Other strategies include the administration of anti-cancer agents, such as cisplatin, 5-FU or paclitaxel. Some treatments are only used for patients who are already in the advanced stages of their cancer.

Unverified Answer

What are common treatments for urinary bladder cancer?

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• Tumor size, multiplicity, metastases, and histological grade are all important factors that influence treatment choice. • The choice of radiation dose, chemotherapy regimen, and urology consultation should be determined based on tumor size, grade, metastasis, and treatment-related complications. • Prognosis is determined by many complicated factors, including age, disease stage, and baseline health. • Clinical trials and long-term follow-up are suggested in order to understand the effects of different treatment plans and to improve outcomes.

Unverified Answer

How many people get urinary bladder cancer a year in the United States?

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Currently, there is a 0,002% incidence of bladder cancer in the United States. In the past 10 years though (1996 to 2006) the incidence rate decreased by about 22%. These decreases may be partly attributable to declining use of cytological screening for urothelial carcinoma, urinary tract infections, and over-the-counter anticholinergics.

Unverified Answer

What are the signs of urinary bladder cancer?

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Dysuria (difficulty passing urine), hematuria (blood in the urine), and frequency (increased urination) are signs of bladder cancer. The presence of bladder tenderness also points to this diagnosis. These signs are present in up to 70% of cases. The presence of one or more of these signs does not by itself imply bladder cancer. Patients must be referred on the basis of the signs because many clinicians are unfamiliar with the symptoms of bladder cancer. The symptoms associated with bladder cancer are so many that clinicians need to work with multiple symptoms when diagnosing a urinary tract disorder. The signs and symptoms of urinary bladder disease are similar to those found in other illnesses and thus physicians with clinical experience in that body should be involved.

Unverified Answer

What causes urinary bladder cancer?

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It is not clear whether this may be a hereditary condition or related to the amount of fluid in the bladder. Tobacco and alcohol seem to be significant causes in this group of patients. The association of the bladder cancer risk with smoking habits and drinking alcohol does not mean that the process leading to bladder cancer is caused by these substances. Tobacco and alcohol are known to cause damage to the urothelium that provides the urinary bladder with an ultrafiltering and barrier function. It remains for others to demonstrate whether bladder cancer can be prevented by quitting smoking and stopping alcohol consumption.

Unverified Answer

Does urinary bladder cancer run in families?

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These data do not support the notion that urinary bladder cancer run in families. However, with our sample sizes limited, the absence of an effect might simply reflect sampling error.

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How quickly does urinary bladder cancer spread?

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More recent studies have shown that [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) tends to spread slowly (Figure 6, 7), but the time taken for the disease to progress differs. The 5-year survival rate for patients with localized cancer (< or=3 cm) is 60%. Patients with metastatic disease (< or =3 cm) have a 5-year survival rate of 42.5%. For patients with advanced disease (3 cm-T1a or T1b, or N x T-stage<2, but no regional lymph nodes involved), the prognosis is worse: the expected 5-year survival rate is 25%.

Unverified Answer

Is abemaciclib safe for people?

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The safety profile of abemaciclib in women with breast cancer is similar to that of previously reported in combination trials with aromatase inhibitors. Data from a recent study, combined with recently published data showing significant antitumour activity of abemaciclib with minimal toxicity in women with advanced breast cancer, highlight the pivotal role of the E2 axis in breast cancer development and progression.

Unverified Answer

What is the average age someone gets urinary bladder cancer?

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The average age at diagnosis of bladder cancer is 70, which is nearly 20 years earlier than in the 1950s. This trend, particularly among women, has been attributed to changes in lifestyles. An alternative explanation is that increased life expectancy following World War I and subsequent improvements in the health of people in some countries have led to an earlier onset of bladder cancer in later life.

Unverified Answer

Is abemaciclib typically used in combination with any other treatments?

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There is no evidence for abemaciclib's use in combination with any other cancer therapies in the current or previous trials. Data from a recent study suggest that the use of abemaciclib may be contraindicated in patients treated with platinum-based doublet or combination chemotherapy.

Unverified Answer

What is the latest research for urinary bladder cancer?

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The prevalence of [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) is increasing globally. Recent advancements have been made in the treatment of both the disease and in understanding its mechanisms. Current research directions are aimed at the development of agents that prolong survival and quality of life in cancer patients, as well as the optimization of current approaches to cancer management.

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