Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.

NCT04299048 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C3651009
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 10

Brief Summary

Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.

Conditions

Cachexia; Non-Small-Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer

Keywords

cachexia, non-small cell lung cancer, pancreatic cancer; colorectal cancer, weight loss, anorexia, muscle loss, fatigue

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An AE was considered an TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs.

  From Day 1 up to Week 24

• Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

  Participants with laboratory test abnormalities (without regard to baseline abnormality) that met pre-specified criteria included Hemoglobin\< 0.8x lower limit of normal (LLN); Hematocrit\< 0.8x LLN; Erythrocytes (Ery.)\< 0.8x LLN; Ery. Mean Corpuscular Volume\< 0.9x LLN; Leukocytes\< 0.6x LLN; Lymphocytes\< 0.8x LLN; Bilirubin\> 1.5x upper limit of normal (ULN); Aspartate Aminotransferase\> 3.0x ULN; Alkaline Phosphatase\> 3.0x ULN; Protein\< 0.8x LLN; Sodium\< 0.95x LLN; Chloride\< 0.9x LLN; Calcium\< 0.9x LLN; Bicarbonate\< 0.9x LLN; Glucose\> 1.5x ULN; C Reactive Protein\> 1.1x ULN; for urinalysis, Urine Glucose ≥1, Ketones ≥1, Urine Protein ≥1, Urine Hemoglobin ≥1, Urobilinogen ≥1, Nitrite ≥1, and Leukocyte ≥1 Esterase ≥1; Hyaline Casts \>1/LPF.

  From Day 1 up to Week 24

• Number of Participants With Post-Baseline Vital Signs Abnormalities

  Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in vital signs, were supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg), supine SBP increase/decrease from baseline ≥30 mmHg; supine diastolic blood pressure (DBP) \<50 mmHg, supine DBP increase/decrease from baseline ≥20 mmHg; supine pulse rate \<40 beats per minute (bpm) or \>120 bpm.

  From Day 1 up to Week 24

• Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities

  ECG data (PR interval, QRS interval, QT interval, and QTcF) were obtained with participant in the supine position. The pre-specified categorical analysis criteria in ECG, were PR interval: value ≥300 milliseconds (msec), percentage change ≥25/50%; QRS interval: value ≥140 msec, percentage change ≥50%; QT interval: value ≥500 msec; QTcF interval: 470\< value ≤480 msec, 480\< value ≤500 msec, value \>500 msec, and 30\< change ≤60 msec, change \>60 msec.

  From Day 1 up to Week 24

Secondary Outcomes (2)

• Serum Unbound Trough Concentrations (Ctrough) of PF-06946860

  Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15

• Serum Total Ctrough of PF-06946860

  Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15

Study Arms (1)

PF-06946860

EXPERIMENTAL

subcutaneous injection

Drug: PF-06946860

Interventions

PF-06946860 DRUG

subcutaneous injection

PF-06946860

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented histologic or cytologic diagnosis of advanced metastatic NSCLC, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer.
• Cachexia, defined by BMI \<20 kg/m2 with involuntary weight loss of \>2% within 6 months prior to screening or Involuntary weight loss of \>5% within 6 months prior to screening irrespective of BMI or If medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.;
• Will receive the following for non-small cell lung cancer:
• a platinum + pemetrexed ± pembrolizumab or
• a platinum + nab paclitaxel or paclitaxel ± pembrolizumab or
• pembrolizumab alone
• Will receive the following for pancreatic cancer:
• FOLFIRINOX or
• Nab-Paclitaxel + Gemcitabine
• Gemcitabine
• Will receive the following for colorectal cancer:
• FOLFOX +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
• FOLFIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
• FOLFOXIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
• Pembrolizumab for MSI-H • Will be entering the study at the first or second cycle of their current course of anti-cancer treatment/ therapy.

You may not qualify if:

• All other forms of cancers not specified above unless currently considered cured (\>5 years without evidence of recurrence).
• Planned radiation therapy as part of the primary anti-tumor therapy regimen. However, localized radiation therapy for symptomatic relief is permitted
• Cachexia caused by other reasons: Severe COPD requiring use of home O2, heart failure or AIDS.
• known symptomatic brain metastases requiring steroids.
• Active hepatitis B or C virus.
• Confirmed positive HIV test.
• Current active reversible causes of decreased food intake.
• Receiving tube feedings or parenteral nutrition at Screening.
• Elevated blood pressure that cannot be controlled by medications.
• Women who are pregnant or breast-feeding

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

SCL Health Cancer Centers of Colorado - St. Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81501, United States

Location

Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Tallahassee Memorial Healthcare Cancer Center

Tallahassee, Florida, 32308, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46804, United States

Location

New England Cancer Specialists

Scarborough, Maine, 04074, United States

Location

American Oncology Partners of Maryland, PA

Bethesda, Maryland, 20817, United States

Location

American Oncology Partners of Maryland, PA

Germantown, Maryland, 20874, United States

Location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Cachexia; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms; Colorectal Neoplasms; Weight Loss; Anorexia; Muscular Atrophy; Fatigue

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms, Digestive; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: March 6, 2020
• Study Start: November 17, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: December 14, 2023
• Results First Posted: December 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)