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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05546476




Registration number
NCT05546476
Ethics application status
Date submitted
12/08/2022
Date registered
19/09/2022

Titles & IDs
Public title
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
Scientific title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD (PROACC -1)
Secondary ID [1] 0 0
2022-003016-87
Secondary ID [2] 0 0
C3651003
Universal Trial Number (UTN)
Trial acronym
PROACC-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Pancreatic Cancer 0 0
Colorectal Cancer 0 0
Loss of Appetite 0 0
Fatigue 0 0
Cachexia 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Mental Health 0 0 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ponsegromab
Treatment: Drugs - Placebo for ponsegromab

Experimental: Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment - ponsegromab low dose subcutaneous injection every 4 weeks

Placebo comparator: Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment - Match placebo subcutaneous injection every 4 weeks

Experimental: Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment - ponsegromab medium dose subcutaneous injection every 4 weeks

Experimental: Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment - ponsegromab high dose subcutaneous injection every 4 weeks


Treatment: Drugs: ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment

Treatment: Drugs: Placebo for ponsegromab
Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in body weight for ponsegromab compared to placebo
Timepoint [1] 0 0
baseline, Week 12
Secondary outcome [1] 0 0
Change from baseline in physical activity as measured with remote digital sensors
Timepoint [1] 0 0
baseline, Week 12
Secondary outcome [2] 0 0
change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS and FAACT-5IASS) scores
Timepoint [2] 0 0
baseline, Week 12
Secondary outcome [3] 0 0
Change from baseline in anorexia/appetite; Nausea and vomiting; and Fatigue as measured by the Cancer Related Cachexia Symptom Diary (CRCSD)
Timepoint [3] 0 0
baseline, Week 12
Secondary outcome [4] 0 0
Incidence of adverse events
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Incidence of lab abnormalities
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Incidence of vital sign abnormalities
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Incidence of ECG abnormalities
Timepoint [7] 0 0
Week 12

Eligibility
Key inclusion criteria
Key

* Documented active diagnosis of non-small cell lung, pancreatic, colorectal cancer
* Cachexia defined by Fearon criteria of weight loss
* Serum GDF-15 concentrations
* Signed informed consent
* ECOG PS =3 with life expectancy of at least 4 months to be able to complete Part A.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
* Current active reversible causes of decreased food intake.
* Cachexia caused by other reasons.
* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
* inadequate liver function
* renal disease requiring dialysis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Orange Hospital - Orange
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [5] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [7] 0 0
Western Health-Sunshine & Footscray Hospitals - St Albans
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2800 - Orange
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Burgas
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Haskovo
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Pleven
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Ruse
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Shumen
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Sofia
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Vratsa
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
China
State/province [25] 0 0
Beijing
Country [26] 0 0
China
State/province [26] 0 0
Henan
Country [27] 0 0
China
State/province [27] 0 0
Hubei
Country [28] 0 0
China
State/province [28] 0 0
Jiangsu
Country [29] 0 0
China
State/province [29] 0 0
Jiangxi
Country [30] 0 0
China
State/province [30] 0 0
Shandong
Country [31] 0 0
China
State/province [31] 0 0
Shanghai
Country [32] 0 0
China
State/province [32] 0 0
Shanxi
Country [33] 0 0
China
State/province [33] 0 0
Zhejiang
Country [34] 0 0
Czechia
State/province [34] 0 0
Olomoucký KRAJ
Country [35] 0 0
Czechia
State/province [35] 0 0
Praha 8
Country [36] 0 0
Czechia
State/province [36] 0 0
Stredoceský KRAJ
Country [37] 0 0
Hungary
State/province [37] 0 0
Bács-kiskun
Country [38] 0 0
Hungary
State/province [38] 0 0
Jász-nagykun-szolnok
Country [39] 0 0
Hungary
State/province [39] 0 0
Budapest
Country [40] 0 0
Japan
State/province [40] 0 0
Chiba
Country [41] 0 0
Japan
State/province [41] 0 0
Ehime
Country [42] 0 0
Japan
State/province [42] 0 0
Hyogo
Country [43] 0 0
Japan
State/province [43] 0 0
Kanagawa
Country [44] 0 0
Japan
State/province [44] 0 0
Nagoya, Aichi
Country [45] 0 0
Japan
State/province [45] 0 0
Shizuoka
Country [46] 0 0
Japan
State/province [46] 0 0
Tokyo
Country [47] 0 0
Japan
State/province [47] 0 0
Kyoto
Country [48] 0 0
Poland
State/province [48] 0 0
Malopolskie
Country [49] 0 0
Poland
State/province [49] 0 0
Podlaskie
Country [50] 0 0
Poland
State/province [50] 0 0
Pomorskie
Country [51] 0 0
Poland
State/province [51] 0 0
Grudziadz
Country [52] 0 0
Poland
State/province [52] 0 0
Katowice
Country [53] 0 0
Poland
State/province [53] 0 0
Lublin
Country [54] 0 0
Poland
State/province [54] 0 0
Slaskie
Country [55] 0 0
Slovakia
State/province [55] 0 0
Banska Bystrica
Country [56] 0 0
Slovakia
State/province [56] 0 0
Bratislava
Country [57] 0 0
Slovakia
State/province [57] 0 0
Nitra
Country [58] 0 0
Slovakia
State/province [58] 0 0
Nove Zamky
Country [59] 0 0
Slovakia
State/province [59] 0 0
Partizanske
Country [60] 0 0
Slovakia
State/province [60] 0 0
Trnava
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona [barcelona]
Country [62] 0 0
Spain
State/province [62] 0 0
Catalunya [cataluña]
Country [63] 0 0
Spain
State/province [63] 0 0
Illes Balears [islas Baleares]
Country [64] 0 0
Spain
State/province [64] 0 0
Valenciana, Comunitat
Country [65] 0 0
Spain
State/province [65] 0 0
Madrid
Country [66] 0 0
Spain
State/province [66] 0 0
València
Country [67] 0 0
Taiwan
State/province [67] 0 0
Tainan
Country [68] 0 0
Taiwan
State/province [68] 0 0
Kaohsiung
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taichung
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05546476