Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Weight Loss

Melanoma

Anorexia

Body Weight

Nausea

Vomiting

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Signs and Symptoms, Digestive

Neuroendocrine Tumor

Neuroepithelioma

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Antineoplastic Agents

Palonosetron

Cisplatin

Vinblastine

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

2 Days Palonosetron 0.25 mg intravenous (IV)

0.25 mg IV (By Vein) Daily for 2 Days or 0.25 mg IV Daily for 3 Days.

Agop Y. Bedikian, MD

Primary Objectives:

* Safety of palonosetron administered for control of nausea and vomiting in patients with metastatic melanoma receiving biochemotherapy.
* To determine the patterns and severity of nausea and vomiting in two groups of patients with metastatic melanoma receiving biochemotherapy with palonosetron premedication using two schedules of palonosetron administration.

Palonosetron is designed to work by blocking the substance serotonin from binding to the brain and gastrointestinal tract, which may help to decrease nausea and vomiting.

Participants in this study will be receiving biochemotherapy treatment as part of their routine care. This treatment will include 3 chemotherapy drugs (cisplatin, vinblastine, and DTIC) and 2 drugs that stimulate the immune system (interferon and interleukin-2 (IL-2)). Biochemotherapy often causes nausea, vomiting, loss of appetite, and weight loss. Palonosetron will be given on this study to try to treat the side effects of biochemotherapy.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups. You have an equal chance of being assigned to either group.

Participants in Group 1 will receive palonosetron by vein over a few minutes starting 30 minutes before receiving chemotherapy on Days 1 and 4 of therapy. Participants in Group 2 will receive palonosetron by vein over a few minutes on Days 1, 3, and 5.

All participants on this study will also receive Ativan by vein every 8 hours for 5 days. Ativan is given for additional control of nausea and it will also help to sedate you. In addition to palonosetron, you may be given standard anti-nausea medications such as lorazepam or compazine if you experience intolerable nausea and vomiting while on study.

You will also be asked to fill out a Functional Living Index-Emesis (FLIE) questionnaire every day for 7 days in a row. The questionnaire will ask about any nausea and/or vomiting you are experiencing and the effect of the therapy on your quality of life. You will stay in the hospital for at least 7 days while you receive treatment.

After the first course of palonosetron given with biochemotherapy, your doctor will decide if you will receive additional courses of palonosetron or if you will be given another anti-nausea drug.

If your doctor does decide to have you continue on palonosetron, it will be given off study. Your participation in this study will be over after 1 course.

This is an investigational study. Palonosetron has been approved by FDA for control of nausea and vomiting caused by chemotherapy. However, it has not been adequately evaluated for safety and effectiveness in patients receiving high dose interleukin-2 alone or in combination with chemotherapy. About 30 patients will take part in this study. All patients will enrolled at M. D. Anderson.

Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

Evaluation of Two Different Schedules of Palonosetron for the Prevention of Nausea and Vomiting in Patients With Metastatic Melanoma Receiving Concurrent Biochemotherapy

Participants response measured as incidences biochemotherapy emesis and those of nausea interfering with appetite, sleep, physical activity, social life and enjoyment of life are summarized. Response evaluated during 5-day administration of biochemotherapy and the 23 subsequent days after therapy ends.

Eisai Inc.

M.D. Anderson Cancer Center

3 Days Palonosetron 0.25 mg intravenous (IV)

3 Days Palonosetron

2 Days Palonosetron

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Agop Bedikian, MD Professor

Nausea Episodes (First 7 days)

Vomiting Episodes (First 7 days)

Cumulative Participants Response to Palonosetron

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Fatigue

Breast Neoplasms

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Wasting Syndrome

Cachexia

Syndrome

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

PF-06946860

Placebo for PF-06946860

Pfizer CT.gov Call Center

Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under the skin) doses.

A 6 week double blind study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated doses injected under the skin (subcutaneously).

During the initial 6-week treatment period (Part A), a total of 2 doses of study drug or placebo will be administered 3 weeks apart. Each dose contains two injections. Part B is an optional 18-week open-label treatment period where up to 7 doses of study drug may be administered. Part B does not include placebo.

Assessments include:

* Measure the impact of the study drug on appetite, fatigue, and pain questionnaires
* Body weight measurements
* Blood samples to evaluate safety and additional endpoints including the amount of the study drug in the blood and the effects of the study drug on levels of a specific cytokine.

Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.

Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia

A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN STUDY TO ASSESS THE EFFECT OF REPEATED SUBCUTANEOUS ADMINISTRATION OF PF-06946860 ON APPETITE IN PARTICIPANTS WITH ADVANCED CANCER AND ANOREXIA, FOLLOWED BY AN 18-WEEK OPEN-LABEL TREATMENT PERIOD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite.

In this Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group.

The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite.

In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score were summarized descriptively by treatment group and timepoint.

The Cancer-Related Cachexia Symptom Assessment-Fatigue was a self-reported questionnaire that measured the severity of fatigue. The measure consisted of 1 question that asked study participants to rate their fatigue over the past 7 days from 0-"no fatigue" to 10-"worst possible fatigue", where higher score indicated worse fatigue.

In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Fatigue score were summarized descriptively by treatment group and timepoint.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs are events between first dose of study drug and up to discharge from study that are absent before treatment or that worsen relative to pretreatment state. An SAE is any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.

Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, erythrocytes mean corpuscular volume, erythrocytes mean corpuscular hemoglobin, erythrocytes mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, basophils, eosinophils and monocytes), chemistry (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate and glucose) and urine (pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes \[/high power field (HPF)\], urine leukocytes \[/HPF\] and hyaline casts \[/low power field (LPF)\]).

Pfizer

The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

AE data was planned to be collected and analyzed separately for Part A and Part A + Part B combined. No individual AE analysis was done for Part B.

Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.

Placebo

Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.

PF-06946860 200mg Q3W

Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.

Placebo -> OL PF-06946860 200mg Q3W

Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC. Starting at the Week 6 visit, participants who continued to the optional OLT period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.

PF-06946860 200mg Q3W -> OL PF-06946860 200mg Q3W

Age, Continuous

18-44

45-64

>=65

Age, Customized

Ethnicity (NIH/OMB)

White

Black or African American

Asian

Race/Ethnicity, Customized

The baseline analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Pfizer ClinicalTrials.gov Call Center

The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed/number analyzed = number of participants evaluable for this OM in each treatment group.

Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A

Week 1

Week 2

Week 3

Week 5

Week 6

The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed at each timepoint in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed = number of participants evaluable for this OM, number analyzed = number of participants evaluable at each timepoint for each treatment group.

Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A

Week 4

Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A

Participants With All-Causality TEAEs

Participants With All-Causality SAEs

The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A

Hemoglobin <0.8 x lower limit of normal (LLN)

Hematocrit <0.8 x LLN

Erythrocytes <0.8 x LLN

Erythrocytes Mean Corpuscular Volume <0.9 x LLN

Erythrocytes Mean Corpuscular Volume >1.1 x upper limit of normal (ULN)

Erythrocytes Mean Corpuscular Hemoglobin <0.9 x LLN

Erythrocytes Mean Corpuscular Hemoglobin >1.1 x ULN

Erythrocytes Mean Corpuscular Hemoglobin Concentration <0.9 x LLN

Erythrocytes Mean Corpuscular Hemoglobin Concentration >1.1 x ULN

Platelets <0.5 x LLN

Platelets >1.75 x ULN

Leukocytes <0.6 x LLN

Leukocytes >1.5 x ULN

Lymphocytes <0.8 x LLN

Lymphocytes >1.2 x ULN

Basophils >1.2 x ULN

Eosinophils >1.2 x ULN

Monocytes >1.2 x ULN

Bilirubin >1.5 x ULN

Aspartate Aminotransferase >3.0 x ULN

Alanine Aminotransferase >3.0 x ULN

Alkaline Phosphatase >3.0 x ULN

Protein <0.8 x LLN

Protein >1.2 x ULN

Albumin <0.8 x LLN

Albumin >1.2 x ULN

Blood Urea Nitrogen >1.3 x ULN

Creatinine >1.3 x ULN

Urate >1.2 x ULN

Sodium <0.95 x LLN

Sodium >1.05 x ULN

Potassium <0.9 x LLN

Potassium >1.1 x ULN

Chloride <0.9 x LLN

Chloride >1.1 x ULN

Calcium <0.9 x LLN

Calcium >1.1 x ULN

Bicarbonate <0.9 x LLN

Bicarbonate >1.1 x ULN

Glucose <0.6 x LLN

Glucose >1.5 x ULN

pH <4.5

pH >8

Urine Glucose >=1

Ketones >=1

Urine Protein >=1

Urine Hemoglobin >=1

Urobilinogen >=1

Urine Bilirubin >=1

Nitrite >=1

Leukocyte Esterase >=1

Urine Erythrocytes (/HPF) >=20

Urine Leukocytes (/HPF) >=20

Hyaline Casts (/LPF) >1

PF- 06946860 200mg Q3W

The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, with at least one observation of the given laboratory test while on study treatment or during lag time.

Number of Participants With Laboratory Test Abnormalities in Part A

Participants received placebo during the 6-week double-blind phase (Part A) 3 weeks apart (Q3W) subcutaneously (SC). Starting at the Week 6 visit, participants who continued to the optional open-label treatment (OLT) period of up to 18 weeks (Part B) had an opportunity to receive up to 7 additional doses of PF-06946860 200 mg Q3W. Each dose was comprised of two 1 mL SC injections which were administered consecutively.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting	NCT00412425	Melanoma	Palonosetron	18 Years - 65 Years	M.D. Anderson Cancer Center
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia	NCT04803305	Non-small Cell ... Pancreatic Canc... Colorectal Canc... Prostate Cancer Breast Cancer Ovarian Cancer Loss of Appetit... Fatigue Cachexia Anorexia	PF-06946860 Placebo for PF-...	18 Years -	Pfizer
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S	NCT04430842	Astrocytoma Brain Cancer Brain Metastase... Bladder Cancer Breast Cancer Cervical Cancer Cholangiocarcin... Colorectal Canc... Esophagus Cance... Gastric Cancer Head and Neck C... Kidney Cancer Liver Cancer Lung Cancer Melanoma Ovarian Cancer Pancreatic Canc... Pleural Mesothe... Prostate Cancer Sarcoma Tongue Cancer Thymic Carcinom... Urinary Tract C...	QBS10072S	18 Years -	Quadriga Biosciences, Inc.
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced and Incurable Solid Tumors	NCT05705492	Advanced Malign...	Biospecimen Col... Computed Tomogr... Olanzapine Placebo Adminis... Questionnaire A...	18 Years -	OHSU Knight Cancer Institute
Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting	NCT00412425	Melanoma	Palonosetron	18 Years - 65 Years	M.D. Anderson Cancer Center
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15	NCT05546476	Non-small Cell ... Pancreatic Canc... Colorectal Canc... Loss of Appetit... Fatigue Cachexia	ponsegromab Placebo for pon...	18 Years -	Pfizer
Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting	NCT00412425	Melanoma	Palonosetron	18 Years - 65 Years	M.D. Anderson Cancer Center
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced and Incurable Solid Tumors	NCT05705492	Advanced Malign...	Biospecimen Col... Computed Tomogr... Olanzapine Placebo Adminis... Questionnaire A...	18 Years -	OHSU Knight Cancer Institute

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