Colorectal Cancer Clinical Trial
Official title:
A PHASE 1B, 12-WEEK, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS FOLLOWING REPEATED SUBCUTANEOUS ADMINISTRATIONS OF PF-06946860 IN PATIENTS WITH CANCER AND CACHEXIA
Verified date | March 2023 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
Status | Completed |
Enrollment | 11 |
Est. completion date | March 30, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. - Adequate renal and liver function. - Signed informed consent. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | American Oncology Partners of Maryland, PA | Bethesda | Maryland |
United States | Beverly Hills Cancer Center | Beverly Hills | California |
United States | Duke Cancer Center | Durham | North Carolina |
United States | Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana |
United States | American Oncology Partners of Maryland, PA | Germantown | Maryland |
United States | SCL Health Cancer Centers of Colorado - St. Mary's Hospital and Regional Medical Center | Grand Junction | Colorado |
United States | New England Cancer Specialists | Scarborough | Maine |
United States | VA Puget Sound Health Care System | Seattle | Washington |
United States | Tallahassee Memorial Healthcare Cancer Center | Tallahassee | Florida |
United States | Lutheran Medical Center | Wheat Ridge | Colorado |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Serum Unbound Trough Concentrations (Ctrough) of PF-06946860 | Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum unbound Ctrough was summarized by time and treatment group. | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 | |
Secondary | Serum Total Ctrough of PF-06946860 | Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum total Ctrough was summarized by time and treatment group. | Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15 |
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