Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
| Phase 1 |
Detailed Description
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:
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Measure the impact of the study drug on appetite, fatigue, and pain questionnaires
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Body weight measurements
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Double-Blind PF-06946860 Treatment followed by Open Label PF-06946860 Treatment subcutaneous injection | Drug: PF-06946860 subcutaneous injection |
Placebo Comparator: Double-Blind Placebo Treatment followed by Open-Label PF-06946860 Treatment subcutaneous injection | Drug: PF-06946860 subcutaneous injection Drug: Placebo for PF-06946860 subcutaneous injection |
Outcome Measures
Primary Outcome Measures
- effect of PF 06946860 compared to placebo on appetite [Week 4]
Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale.
Secondary Outcome Measures
- effect of PF 06946860 compared to placebo on appetite [Weeks 1, 2, 3, 5 and 6]
Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Appetite score based on 11-point numerical rating scale.
- effect of PF 06946860 compared to placebo on fatigue [Weeks 1, 2, 3, 4, 5 and 6.]
Change from baseline for patient reported 7-day recall Cancer Related Cachexia Symptom Assessment-Fatigue score based on 11-point numerical rating scale.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Week 6]
Incidence of adverse events
- Incidence of laboratory abnormalities [Safety and Tolerability] [Week 6]
Incidence of laboratory abnormalities
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast or ovarian cancer which, in the treating oncologist's assessment, is considered advanced.
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Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment Appetite 7-day recall scale
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Meets any of the following criteria at Randomization:
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Not currently receiving antineoplastic therapy
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On standard of care systemic antineoplastic therapy or treatment without curative intent
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Signed informed consent.
Key Exclusion Criteria:
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Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
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Current active reversible causes of decreased food intake.
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Current, severe gastrointestinal disease
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Participants with known symptomatic brain metastases requiring steroids.
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Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, HIV or participants with known AIDS-related illness
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inadequate renal or liver function.
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Women who are pregnant or breast-feeding
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Carti Cancer Center | Little Rock | Arkansas | United States | 72205 |
2 | Tower Hematology Oncology Medical Group (THO) | Beverly Hills | California | United States | 90211 |
3 | Ventura County Hematology- Oncology Specialists | Camarillo | California | United States | 93010 |
4 | Cedars- Sinai Medical Center | Los Angeles | California | United States | 90048 |
5 | Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | United States | 90048 |
6 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
7 | Ventura County Hematology Oncology Specialists | Oxnard | California | United States | 93030 |
8 | Providence Medical Foundation | Santa Rosa | California | United States | 95403 |
9 | Ventura County Hematology-Oncology Specialists | Ventura | California | United States | 93003 |
10 | Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
11 | Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | United States | 46804 |
12 | Bozeman Health Cancer Center | Bozeman | Montana | United States | 59715 |
13 | Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research | Bozeman | Montana | United States | 59715 |
14 | Bozeman Health Deaconess Hospital | Bozeman | Montana | United States | 59715 |
15 | Mary Crowley Cancer Research | Dallas | Texas | United States | 75230 |
16 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
17 | US Oncology Investigational Product Center (IPC) | Irving | Texas | United States | 75063 |
18 | Texas Oncology - Longview Cancer Center | Longview | Texas | United States | 75601 |
19 | Texas Oncology-Paris | Paris | Texas | United States | 75460 |
20 | Texas Oncology- Tyler | Tyler | Texas | United States | 75702 |
21 | Cancer Center IDS Pharmacy | Charlottesville | Virginia | United States | 22903 |
22 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22903 |
23 | UVA Health System; Attention: GI Team | Charlottesville | Virginia | United States | 22903 |
24 | University of Virginia Health System | Charlottesville | Virginia | United States | 22908 |
25 | MultiCare Regional Cancer Center - Auburn | Auburn | Washington | United States | 98001 |
26 | MultiCare Regional Cancer Center - Gig Harbor Medical Park | Gig Harbor | Washington | United States | 98335 |
27 | MultiCare Regional Cancer Center - Puyallup | Puyallup | Washington | United States | 98372 |
28 | Medical Oncology Associates, PS (dba Summit Cancer Centers) | Spokane Valley | Washington | United States | 99216 |
29 | MultiCare Institute for Research & Innovation | Tacoma | Washington | United States | 98405 |
30 | MultiCare Regional Cancer Center - Tacoma | Tacoma | Washington | United States | 98405 |
31 | Wenatchee Valley Hospital | Wenatchee | Washington | United States | 98801 |
32 | The Ottawa Hospital Cancer Centre | Ottawa | Ontario | Canada | K1H 8L6 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C3651010