Safety, Tolerability, PK and PD Following SC PF-06946860 in Patients With NSCLC and Cachexia
NCT04299048
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- Documented diagnosis of stage III or advanced metastatic stage IV NSCLC.
- 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 platinum-based therapy with a platin + pemetrexed ± pembrolizumab or platin + nab paclitaxel
± pembrolizumab as first or second line therapy; and at the first cycle of platinum based therapy.
- Adequate renal and liver function.
- Signed informed consent.
- Other forms of lung cancer
- 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
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Descriptive Information | |||||
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Brief Title ICMJE | Safety, Tolerability, PK and PD Following SC PF-06946860 in Patients With NSCLC and Cachexia | ||||
Official Title ICMJE | 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 NON-SMALL CELL LUNG CANCER AND CACHEXIA | ||||
Brief Summary | This 12-week open-label study will explore how PF-06946860 is tolerated, the effects of the study drug, the best dose for treatment and how participants with Non Small Cell Lung Cancer and cachexia feel after receiving repeated subcutaneous dosing. | ||||
Detailed Description | This 12-week open-label study will explore how PF-06946860 is tolerated, the effects of the study drug, the best dose for treatment and how participants with Non Small Cell Lung Cancer and cachexia feel after receiving repeated subcutaneous dosing.During the 12-week treatment period, study drug will be administered subcutaneously every 3 weeks for a total of 5 doses. There is a 12-week follow-up period following the last dose of study drug. Additional assessments include:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE |
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Intervention ICMJE | Drug: PF-06946860
subcutaneous injection | ||||
Study Arms ICMJE | Experimental: subcutaneous injection
Intervention: Drug: PF-06946860 | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 16 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 12, 2021 | ||||
Estimated Primary Completion Date | September 12, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04299048 | ||||
Other Study ID Numbers ICMJE | C3651009 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |