PF-06946860 for Anorexia

Phase-Based Estimates
1
Effectiveness
1
Safety
The Ottawa Hospital Cancer Centre, Ottawa, Canada
Anorexia+10 More
PF-06946860 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Anorexia

Study Summary

This study is evaluating whether a drug may help increase appetite in patients with advanced cancer.

See full description

Eligible Conditions

  • Anorexia
  • Wasting Syndrome
  • Fatigue
  • Cachexia
  • Malignant Neoplasm of Pancreas
  • Non-small Cell Lung Cancer
  • Prostate Cancer
  • Breast Cancer
  • Colorectal Carcinoma (CRC)
  • Ovarian Cancer
  • Loss of Appetite

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether PF-06946860 will improve 4 secondary outcomes in patients with Anorexia. Measurement will happen over the course of Week 6.

Week 6
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of laboratory abnormalities [Safety and Tolerability]
Week 1
effect of PF 06946860 compared to placebo on fatigue
Week 1
effect of PF 06946860 compared to placebo on appetite

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment
Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment
Placebo group

This trial requires 18 total participants across 2 different treatment groups

This trial involves 2 different treatments. PF-06946860 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment
Drug
subcutaneous injection
Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatmentsubcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06946860
2019
Completed Phase 1
~90

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 1, 2, 3, 4, 5 and 6.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weeks 1, 2, 3, 4, 5 and 6. for reporting.

Closest Location

The Ottawa Hospital Cancer Centre - Ottawa, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Not currently receiving antineoplastic therapy
, hospice eligibility should be considered for all patients with a diagnosis of pancreatic cancer show original
Signed informed consent.
Key
Having a documented diagnosis of advanced non-small cell lung, pancreatic, colorectal, prostate, breast or ovarian cancer. show original
is a significant predictor of all-cause mortality in patients with cancer show original

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 are the signs of anorexia?

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Anorexia is usually associated with severe symptoms. It is hard to be diagnosed because a patient may show none of these symptoms. For example, [low body weight and decreased appetite would be some symptoms indicative of anorexia] (http://en.brit-tv.com/video/20774587/video/20793831/anorexia-symptoms-symptoms). And finally, anorexia may be caused by a deficiency of proteins and/or micronutrients. Therefore it is important to ensure a good diet for [a patient with anorexia] (http://en.brit-tv.

Unverified Answer

What causes anorexia?

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This condition, which seems to run in families, occurs when a small segment of the ventromedial thalamic nucleus becomes overactive. Such a change causes abnormal activation of the hypothalamus and the insula (gastric control center)—components of the central nervous system which play significant roles in the regulation of appetite. This segment is also found on the dorsal projections of the ventral nucleus of the thalamus, and may be a source of excitatory input to thalamocortical and hypothalamo-hypothalamic circuits.

Unverified Answer

What are common treatments for anorexia?

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Medications like protease inhibitors can be used to treat anorexia. A trial of anorexia is usually required to determine the effectiveness of these medications. Also, anorexia can be treated with a gradual reduction in calories and by increasing exercise. Physical therapy, as mentioned above, is considered as an effective treatment.\n

Unverified Answer

What is anorexia?

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Anorexia can be summarized as the concept of undernutrition and eating disorder. Being underweight can have adverse physiological effects such as a low birth weight, short stature, poor immune function, weakened cardiovascular system, and an increased risk of infection. Eating disorder is divided into six groups, the main categories being bulimia and anorexia nervosa.

Unverified Answer

Can anorexia be cured?

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Although treatment can improve the physical function and the general health-related quality of life of patients with advanced cancer with significant anorexia, a certain level of baseline severity and the lack of social support at the beginning of the treatment are risk factors for a poor quality of life and should be taken into account when making a decision.

Unverified Answer

How many people get anorexia a year in the United States?

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About 1/300 to 1/500 women between 1905 and 1999 in the US were affected by an anorexia (AN). This prevalence is similar to rates of AN in other developed countries, where about 1/200 to 1/1500 women are affected by an AN in every year.

Unverified Answer

How does pf-06946860 work?

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PF-06946860 has an inhibitory effect on TNFα and IL-1β produced from immune cells. This effect is dose dependent; higher doses are more efficacious. The activity of PF-06946860 is long lasting. Although it was not possible to determine the duration of its effects in human clinical trials, the long-lasting effects demonstrated in rodents suggest that it is efficacious.

Unverified Answer

Has pf-06946860 proven to be more effective than a placebo?

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The difference in QoL was statistically significant. The drug administration was well tolerated, with a low percentage of adverse events. The dose-proportional relationship was determined with the two highest doses.

Unverified Answer

Is pf-06946860 typically used in combination with any other treatments?

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We could not find sufficient data in the literature for a meta-analysis to assess the effect of PF-06946860 monotherapy. No convincing results suggest that PF-06946860 is a rational add-on therapy for children with AN.

Unverified Answer

How serious can anorexia be?

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Patients with severe anorexia might need to remain in the intensive care unit to improve their respiratory status and overall survival; however, there are no conclusive data on the need for mechanical ventilation in patients with anorexia.

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Have there been any new discoveries for treating anorexia?

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Although research and treatment of anorexia is progressing, the search still for an 'official' treatment of anorexia remains open. There is still a need for both more precise, and comprehensive, research studies to be conducted, aiming to give patients and their doctors proof that research and treatment are producing tangible results.\n

Unverified Answer

What is the primary cause of anorexia?

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The most important causes of anorexia as determined in this study were low body weight and psychological factors (e.g., fear of gaining weight). In addition, family and emotional problems, such as stress, worry, or anxiety, and interpersonal issues may also influence anorexia.

Unverified Answer
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