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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01503372




Registration number
NCT01503372
Ethics application status
Date submitted
22/12/2011
Date registered
4/01/2012
Date last updated
12/02/2019

Titles & IDs
Public title
FLO +/- Pazopanib as First-line Treatment in Advanced Gastric Cancer
Scientific title
Pazopanib With 5-Fluorouracil, Leucovorin and Oxaliplatin (FLO) as 1st-line Treatment in Advanced Gastric Cancer; a Randomized Phase-II-study of the Arbeitsgemeinschaft Internistische Onkologie
Secondary ID [1] 0 0
2010-024379-15
Secondary ID [2] 0 0
PaFLO
Universal Trial Number (UTN)
Trial acronym
PaFLO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pazopanib
Treatment: Drugs - 5-FU, Oxaliplatin, Leukovorin (FLO)

Experimental: Arm A: FLO + Pazopanib -

Active comparator: Arm B: FLO -


Treatment: Drugs: Pazopanib
Adding Pazopanib to a standard chemotherapy consisting of FLO. 800 mg (2x400mg or 4x200mg) Pazopanib per day should be taken orally without food at least one hour before or two hours after a meal. Pazopanib will be given d1-14 each cycle (2 weeks cycles) with 12 cycles of chemotherapy FLO (d 1, each cycle). After 12 cycles chemotherapy FLO will be discontinued and Pazopanib will be given alone until disease progression

Treatment: Drugs: 5-FU, Oxaliplatin, Leukovorin (FLO)
Oxaliplatin 85 mg/m2 2h iv Leucovorin 200mg/m2 2h - iv FU 2600mg/m2 24h iv q2w for 12 cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
Timepoint [1] 0 0
Immediately after injection.
Primary outcome [2] 0 0
progression-free survival rate at 6 months
Timepoint [2] 0 0
6 months after study entry
Secondary outcome [1] 0 0
progression-free survival rate at 9 and 12 months
Timepoint [1] 0 0
9 and 12 months after study entry
Secondary outcome [2] 0 0
median progression-free survival
Timepoint [2] 0 0
48 months
Secondary outcome [3] 0 0
response rate
Timepoint [3] 0 0
48 months
Secondary outcome [4] 0 0
duration of response
Timepoint [4] 0 0
48 months
Secondary outcome [5] 0 0
toxicity
Timepoint [5] 0 0
48 months
Secondary outcome [6] 0 0
tolerability
Timepoint [6] 0 0
48 months
Secondary outcome [7] 0 0
overall survival
Timepoint [7] 0 0
48 months
Secondary outcome [8] 0 0
time to treatment failure
Timepoint [8] 0 0
48 months
Secondary outcome [9] 0 0
evaluation of the predictive and prognostic relevance of biomarkers
Timepoint [9] 0 0
48 months
Secondary outcome [10] 0 0
Mean Injection Site Pain on a Visual Analogue Scale (VAS)
Timepoint [10] 0 0
15 minutes post injection
Secondary outcome [11] 0 0
Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale
Timepoint [11] 0 0
10 minutes and 30 minutes after injection
Secondary outcome [12] 0 0
Percentage of Participants With no Erythema in the Draize Scale
Timepoint [12] 0 0
10 minutes and 30 minutes after injection
Secondary outcome [13] 0 0
Percentage of Participants With no Edema in the Draize Scale
Timepoint [13] 0 0
10 minutes and 30 minutes after injection
Secondary outcome [14] 0 0
Percentage of Participants With no Pruritus in the Draize Scale
Timepoint [14] 0 0
10 minutes and 30 minutes after injection
Secondary outcome [15] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [15] 0 0
Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious adverse events were collected from the time that participant signed the informed consent.

Eligibility
Key inclusion criteria
* Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.
* Age = 18 years.
* Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction with either metastatic or locally advanced disease, incurable by operation.
* Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2
* At least one unidimensional, measurable tumor parameter (according to RECIST 1.1)
* No preceding cytotoxic therapy (neoadjuvant or adjuvant treatment allowed if finished > 6 months before inclusion)
* Adequate organ system function.
* Men and women must perform an adequate contraception.
* Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior malignancy, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.
* Overexpression of HER-2, defined as IHC 3+ or IHC 2+ and FISH positive.
* Known hypersensitivity against 5-FU, leukovorin, oxaliplatin or other platinum compounds or pazopanib.
* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.
* Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or the absorption of investigational product
* Presence of uncontrolled infection.
* Corrected QT interval (QTc) > 480 ms using Bazett's formula.
* History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, NYHA III or IV congestive heart failure.
* Poorly controlled hypertension.
* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
* Evidence of active bleeding or bleeding diathesis.
* Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
* Hemoptysis in excess of 2.5 ml within 8 weeks of first dose of study drug.
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
* Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.
* Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib. A neoadjuvant or adjuvant chemotherapy must be finished at least 6 month before study entry.
* Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
* Grade 3 or 4 diarrhea.
* Peripheral polyneuropathy > NCI Grade.
* Pregnant or lactating women.
* Men or women who are planning a pregnancy within the next six months.
* Participation in another clinical trial with investigational agents within the last 30 days prior to study start.
* The patient is a colleague or employed by the study investigator or by an involved institution including the sponsor of the study.
* Patient is detained in a psychiatric unit or imprisoned.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/12/2017
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 63354 - Malvern East
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 63355 - Maroochydore
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 63353 - Shenton Park
Recruitment postcode(s) [1] 0 0
3145 - Malvern East
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
6008 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Berlin
Country [2] 0 0
Canada
State/province [2] 0 0
Hamilton
Country [3] 0 0
Canada
State/province [3] 0 0
Winnipeg
Country [4] 0 0
Germany
State/province [4] 0 0
Munich
Country [5] 0 0
Germany
State/province [5] 0 0
Ostseebad Damp

Funding & Sponsors
Primary sponsor type
Other
Name
Charite University, Berlin, Germany
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Peter Thuss-Patience, MD
Address 0 0
Charite University medicine
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

No information has been provided regarding IPD availability


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/NCT01503372