Stomach NeoplasmsPhase 3ARMANINCT02934464

Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers

A Phase 3 study testing RAMUCIRUMAB, Paclitaxel and FOLFOX 4 in people with Stomach Neoplasms, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a randomized, open-label, multicenter phase III trial of ramucirumab plus paclitaxel, given as switch maintenance, versus continuation of first-line chemotherapy, given as per standard clinical practice, in subjects with unresectable locally advanced or metastatic HER-2 negative gastric or GEJ cancer, without… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stomach Neoplasms
What is being tested?: RAMUCIRUMAB, Paclitaxel and FOLFOX 4
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 280 participants
Where: 1 siteItaly
Study dates: Dec 2016to Dec 2021
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must meet the following criteria for study entry:
Written informed consent prior to performance of any study procedure;
Age ≥18 years;
ECOG Performance Status 0-1 (Appendix I);
Life expectancy of at least 12 weeks in the opinion of the Investigator;
Unresectable locally advanced or metastatic, histopathologically confirmed, HER-2 negative adenocarcinoma of gastric or GEJ cancer with measurable and/or evaluable disease based on RECIST, v1.1

Show all 16Show fewer

Must have received lead-in chemotherapy in the first-line setting using one of the fluoropyrimidines- and oxaliplatin-based doublet combinations as specified in Section 7 and continued for three months (i.e. 6 administrations for bi-weekly cycles regimens or 4 administrations for three-weekly cycles regimens). Patients who had received adjuvant cisplatin/oxaliplatin plus fluoropyrimidine-based doublet chemotherapy and had recurrence beyond 12 months from its completion are eligible.
Must have radiological evidence of clinical benefit following the last dose of the lead-in chemotherapy (either CR, PR or SD by RECIST v1.1 criteria in case of measurable disease, or absence of progressive disease in case of non-measurable disease).
Laboratory requirements:
The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1000/µL, hemoglobin ≥9 g/dL (5.58 mmol/L), and platelets ≥100,000/µL.
The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).
The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is >1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). The patient's urinary protein is ≤1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥2+, a 24-hour urine collection for protein must demonstrate <1000 mg of protein in 24 hours to allow participation in this protocol).
Coagulation: The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5, and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to randomization
Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating center.
Archival tumor tissue is required for exploratory research at enrollment.
Because the teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods) for the entire duration of the study including a minimum of 12 weeks after dosing has been completed. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrolment. Women must not be breastfeeding.

Who cannot join

Exclude a patient from this study if any of the following conditions are observed:
HER2 positive status, or the patient has squamous cell.
Prior malignancy, active within 3 years from study entry, except for locally curable cancers that have been apparently cured and need no subsequent therapy, such as non-melanoma skin cancers, superficial bladder cancer or cancer in situ of the breast or cervix.
Has a serious illness or medical condition(s) including, but not limited to the following:
Known brain metastasis or leptomeningeal metastasis.
Active infection (ie, body temperature ≥38°C due to infection).

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Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
Intestinal obstruction, pulmonary fibrosis or interstitial pneumonitis, renal failure, liver failure, or cerebrovascular disorder.
Uncontrolled diabetes.
The patient has symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
Autoimmune disorders or history of organ transplantation that require immunosuppressive therapy.
l.Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
m.The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to randomization.
n.The patient is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. Patients receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR ≤ 1.5 and aPTT ≤ 1.5 x ULN) or (PT ≤ 1.5 x ULN and aPTT ≤1.5 x ULN) are met.
o.The patient is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs, eg, indomethacin, ibuprofen, naproxen or similar agents) or other anti-platelet agents (eg, clopidogrel, ticlopidine, dipyridamole, anagrelide). Aspirin use at doses up to 325 mg/day is permitted.
p.The patient has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to study entry.
q.History of gastrointestinal perforation and/or fistulae within 6 months prior randomization.
r.The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
s.The patient has uncontrolled arterial hypertension ≥ 150 / ≥ 90 mm Hg despite standard medical management.
t.The patient has a serious or non healing wound or peptic ulcer or bone fracture within 28 days prior to randomization.
u.Known allergy or hypersensitivity to monoclonal antibody treatment or any components used in the ramucirumab DP preparation. Known allergy or hypersensitivity to paclitaxel or any components used in the paclitaxel preparation or other contraindication for taxane therapy.
v.Persistent proteinuria of CTCAE Grade 3 (>3.5g/24 hours).
Treatment with any of the following within the specified time frame prior to study drug administration:
Major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to randomization.
Any investigational agent including VEGF or VEGFR-targeted agents within prior 4 weeks
Extended field radiation within prior 4 weeks or limited field radiation within prior 2 weeks.
Unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation). In particular, patients with platinum induced neurotoxicity greater than or equal CTCAE Grade 2 that has not resolved after induction phase should be excluded.
Is a pregnant or lactating female, or is planning to become pregnant during treatment and within 12 weeks after the end of treatment with ramucirumab. Women of child-bearing potential with either positive or no pregnancy test at baseline. Women of child-bearing potential or sexually active men not willing to use contraception during study and for at least 12 weeks after end of treatment with ramucirumab. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
Concomitant participation or participation within the last 30 days in another clinical trial

Trial locations and contacts

1 site in 1 country.

MARIA DI BARTOLOMEO, MD contact

+390223902882

maria.dibartolomeo@istitutotumori.mi.it

Filippo Pietrantonio, MD contact

+390223903807

filippo.pietrantonio@istitutotumori.mi.it

Italy1 site, 1 recruiting

Maria Di Bartolomeo
Milan, 20133
MARIA DI BARTOLOMEO, MD, +390223902882, maria.dibartolomeo@istitutotumori.mi.it
SILVIA LAZZATI, +3923903835, trialcenter@istitutotumori.mi.it
Recruiting

Other trials in Italy

About this study

Official title: Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers: the ARMANI Phase III Trial

The acceptable first-line or lead-in chemotherapy will be:

FOLFOX4:Oxaliplatin 85 mg/m2. l-Leucovorin 100 mg/m2 5-fluorouracil 400/600 mg/m2. Cycle length is 2 weeks +/- 3 days.
ModifiedFOLFOX6: Oxaliplatin a 85 mg/m2. l-Leucovorin 200 mg/m2. 5-fluorouracil 400 mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days.
XELOX:Oxaliplatin130 mg/m2.Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is 3 weeks +/- 3 days.

Read the detailed description

Treatment must be continued for up to 4 three-weekly cycles or 6 bi-weekly cycles, or for up to a maximum of 12 weeks. Subjects with CR/PR/SD after oxaliplatinum compound and fluoropyrimidine-based regimens, or without evidence of progressive disease in case of non-measurable disease, will be randomized in 1:1 ratio between the two treatment arms.

Prior to randomization, subjects will be stratified based on Center; Prior gastrectomy: No vs. Yes; Peritoneal carcinomatosis: Yes vs. No; Site of origin: GEJ vs. gastric.

Conditions: Stomach Neoplasms
Being tested: RAMUCIRUMAB, Paclitaxel, FOLFOX 4, mFOLFOX 6, XELOX
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RAMUCIRUMABDrug
Also called Cyramza
PaclitaxelDrug
Paclitaxel
FOLFOX 4Drug
Also called Oxaliplatino + l-leucovorin + 5 Fluorouracile
mFOLFOX 6Drug
Also called Oxaliplatino + l-leucovorin + 5 Fluorouracile
XELOXDrug
Also called Oxaliplatino + Capecitabina

Study groups in NCT02934464
Study group	Role	What they receive
ARM A	Experimental	* RAMUCIRUMAB 8 mg/kg on Days 1 and 15 of every 28-day cycle * PACLITAXEL 80 mg/m2 on Days 1, 8, and 15 of every 28-day cycle until progressive disease, unacceptable toxicity, informed consent withdrawal or patient's death. Receives: Drug: RAMUCIRUMAB; Drug: Paclitaxel
ARM B	Active comparator	* FOLFOX4: Oxaliplatin 85 mg/m2 + l-Leucovorin 100 mg/m2 + 5-fluorouracil 400/600 mg/m2. Cycle length is 2 weeks +/- 3 days. * mFOLFOX6: Oxaliplatin a 85 mg/m2+ l-Leucovorin 200 mg/m2 + 5-fluorouracil 400 mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days. * XELOX:Oxaliplatin130 mg/m2 + Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is 3 weeks +/- 3 days. Receives: Drug: FOLFOX 4; Drug: mFOLFOX 6; Drug: XELOX

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Measured: 3 years

Secondary outcomes (9)

Overall Survival (OS)
Overall Survival (OS)
Measured: 3 years
Time-to-treatment failure
Time-to-treatment failure
Measured: 3 years
Overall response rate
Overall response rate
Measured: 3 years
Duration of response
Duration of response of patients who receive swich maintenance (arm A) versus patients who receive continuation therapy (arm B).
Measured: 3 years
Percentage of patients in second line therapy
To compare the percentage of patients that will receive a second line therapy according to arm treatment.
Measured: 3 years
Adverse events
Incidence of adverse events, according to CTCAE v4.03
Measured: 3 years
Quality of life EORTC QLQ-C30
PRO are assessed using the questionnaires EORTC QLQ-C30
Measured: 3 years
Quality of life EORTC QLQ-OG25
PRO are assessed using the questionnaire the EORTC QLQ-OG25
Measured: 3 years
Quality of life EuroQol EQ-5D
PRO are assessed using the questionnaire EuroQol EQ-5D
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Dec 2021

First posted17 Oct 2016 (estimated)
Study startDec 2016
Primary completionDec 2021 (estimated)
Study completionDec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 280 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02934464
Sponsor's protocol ID: INT 103-16
Acronym: ARMANI
Status last verified: Sep 2021
First submitted: 6 Oct 2016
Last updated: 13 Sep 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Randon G, Lonardi S, Fassan M, Palermo F, Tamberi S, Giommoni E, Ceccon C, Di Donato S, Fornaro L, Brunetti O, De Vita F, Bittoni A, Chini C, Spallanzani A, Nappo F, Bethaz V, Strippoli A, Latiano T, Cardellino GG, Giuliani F, Morano F, Niger M, Raimondi A, Prisciandaro M, Pircher CC, Sciortino C, Marchesi S, Garattini SK, Airo G, Miceli R, Di Bartolomeo M, Pietrantonio F. Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line oxaliplatin-based chemotherapy in patients with advanced HER2-negative gastric or gastro-oesophageal junction cancer (ARMANI): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 Dec;25(12):1539-1550. doi: 10.1016/S1470-2045(24)00580-1. Epub 2024 Nov 15.
PubMed 39557058
Di Bartolomeo M, Niger M, Morano F, Corallo S, Antista M, Tamberi S, Lonardi S, Di Donato S, Berardi R, Scartozzi M, Cardellino GG, Di Costanzo F, Rimassa L, Luporini AG, Longarini R, Zaniboni A, Bertolini A, Tomasello G, Pinotti G, Scagliotti G, Tortora G, Bonetti A, Spallanzani A, Frassineti GL, Tassinari D, Giuliani F, Cinieri S, Maiello E, Verusio C, Bracarda S, Catalano V, Basso M, Ciuffreda L, De Vita F, Parra HS, Fornaro L, Caporale M, de Braud F, Pietrantonio F. Assessment of Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line chemotherapy in patients with advanced HER-2 negative gastric or gastroesophageal junction cancers: the ARMANI phase III trial. BMC Cancer. 2019 Mar 29;19(1):283. doi: 10.1186/s12885-019-5498-3.
PubMed 30922323

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers: the ARMANI Phase III Trial
ClinicalTrials.gov ID: NCT02934464
Acronym / sponsor ID: ARMANI / INT 103-16
Conditions: Stomach Neoplasms
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 280 participants (estimated)
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
Study start: Dec 2016 (actual)
Primary completion: Dec 2021 (estimated)
Study completion: Dec 2021 (estimated)
First posted: 17 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The acceptable first-line or lead-in chemotherapy will be:

FOLFOX4:Oxaliplatin 85 mg/m2. l-Leucovorin 100 mg/m2 5-fluorouracil 400/600 mg/m2. Cycle length is 2 weeks +/- 3 days.
ModifiedFOLFOX6: Oxaliplatin a 85 mg/m2. l-Leucovorin 200 mg/m2. 5-fluorouracil 400 mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days.
XELOX:Oxaliplatin130 mg/m2.Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is 3 weeks +/- 3 days.

Detailed description

Prior to randomization, subjects will be stratified based on Center; Prior gastrectomy: No vs. Yes; Peritoneal carcinomatosis: Yes vs. No; Site of origin: GEJ vs. gastric.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ARM A	Experimental	Drug: RAMUCIRUMAB, Drug: Paclitaxel* RAMUCIRUMAB 8 mg/kg on Days 1 and 15 of every 28-day cycle * PACLITAXEL 80 mg/m2 on Days 1, 8, and 15 of every 28-day cycle until progressive disease, unacceptable toxicity, informed consent withdrawal or patient's death.
ARM B	Active comparator	Drug: FOLFOX 4, Drug: mFOLFOX 6, Drug: XELOX* FOLFOX4: Oxaliplatin 85 mg/m2 + l-Leucovorin 100 mg/m2 + 5-fluorouracil 400/600 mg/m2. Cycle length is 2 weeks +/- 3 days. * mFOLFOX6: Oxaliplatin a 85 mg/m2+ l-Leucovorin 200 mg/m2 + 5-fluorouracil 400 mg/m2 and 2400 mg/m2 46-hours continous infusion. Cycle length is 2 weeks +/- 3 days. * XELOX:Oxaliplatin130 mg/m2 + Capecitabine will be 2000 mg/m2 for 14 days. Cycle length is 3 weeks +/- 3 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Written informed consent prior to performance of any study procedure;
Age ≥18 years;
ECOG Performance Status 0-1 (Appendix I);
Life expectancy of at least 12 weeks in the opinion of the Investigator;
Unresectable locally advanced or metastatic, histopathologically confirmed, HER-2 negative adenocarcinoma of gastric or GEJ cancer with measurable and/or evaluable disease based on RECIST, v1.1

Key exclusion criteria (31 listed)

HER2 positive status, or the patient has squamous cell.
Prior malignancy, active within 3 years from study entry, except for locally curable cancers that have been apparently cured and need no subsequent therapy, such as non-melanoma skin cancers, superficial bladder cancer or cancer in situ of the breast or cervix.
Has a serious illness or medical condition(s) including, but not limited to the following:
l.Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
m.The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to randomization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RAMUCIRUMABAlso: Cyramza	Drug	ARM A
PaclitaxelPaclitaxel	Drug	ARM A
FOLFOX 4Also: Oxaliplatino + l-leucovorin + 5 Fluorouracile	Drug	ARM B
mFOLFOX 6Also: Oxaliplatino + l-leucovorin + 5 Fluorouracile	Drug	ARM B
XELOXAlso: Oxaliplatino + Capecitabina	Drug	ARM B

Primary outcome

Progression-Free Survival (PFS)
Time frame: 3 years
Progression-Free Survival (PFS)

9 secondary outcomes

Overall Survival (OS)
Time frame: 3 years
Time-to-treatment failure
Time frame: 3 years
Overall response rate
Time frame: 3 years
Duration of response
Time frame: 3 years
Percentage of patients in second line therapy
Time frame: 3 years
Adverse events
Time frame: 3 years
Quality of life EORTC QLQ-C30
Time frame: 3 years
Quality of life EORTC QLQ-OG25
Time frame: 3 years
Quality of life EuroQol EQ-5D
Time frame: 3 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
Derived from this study: PubMed 39557058Randon G, Lonardi S, Fassan M, Palermo F, Tamberi S, Giommoni E, Ceccon C, Di Donato S, Fornaro L, Brunetti O, De Vita F, Bittoni A, Chini C, Spallanzani A, Nappo F, Bethaz V, Strippoli A, Latiano T, Cardellino GG, Giuliani F, Morano F, Niger M, Raimondi A, Prisciandaro M, Pircher CC, Sciortino C, Marchesi S, Garattini SK, Airo G, Miceli R, Di Bartolomeo M, Pietrantonio F. Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line oxaliplatin-based chemotherapy in patients with advanced HER2-negative gastric or gastro-oesophageal junction cancer (ARMANI): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2024 Dec;25(12):1539-1550. doi: 10.1016/S1470-2045(24)00580-1. Epub 2024 Nov 15.
Derived from this study: PubMed 30922323Di Bartolomeo M, Niger M, Morano F, Corallo S, Antista M, Tamberi S, Lonardi S, Di Donato S, Berardi R, Scartozzi M, Cardellino GG, Di Costanzo F, Rimassa L, Luporini AG, Longarini R, Zaniboni A, Bertolini A, Tomasello G, Pinotti G, Scagliotti G, Tortora G, Bonetti A, Spallanzani A, Frassineti GL, Tassinari D, Giuliani F, Cinieri S, Maiello E, Verusio C, Bracarda S, Catalano V, Basso M, Ciuffreda L, De Vita F, Parra HS, Fornaro L, Caporale M, de Braud F, Pietrantonio F. Assessment of Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line chemotherapy in patients with advanced HER-2 negative gastric or gastroesophageal junction cancers: the ARMANI phase III trial. BMC Cancer. 2019 Mar 29;19(1):283. doi: 10.1186/s12885-019-5498-3.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MARIA DI BARTOLOMEO, MD contact

+390223902882

maria.dibartolomeo@istitutotumori.mi.it

Filippo Pietrantonio, MD contact

+390223903807

filippo.pietrantonio@istitutotumori.mi.it

MARIA DI BARTOLOMEO principal investigator

Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RAMUCIRUMAB, Paclitaxel and FOLFOX 4 in people with Stomach Neoplasms, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact MARIA DI BARTOLOMEO, MD (+390223902882, maria.dibartolomeo@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02934464, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.