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Esophagogastric AdenocarcinomaPhase 2MEGANNCT02856867

Nintedanib Plus mFOLFOX6 for Previously Untreated Metastatic Esophagogastric Adenocarcinoma (MEGAN)

A Phase 2 study testing Nintedanib, Fluorouracil and Leucovorin in people with Esophagogastric Adenocarcinoma and Metastatic Disease, run by European Organisation for Research and Treatment of Cancer - EORTC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a prospective, multicenter, randomized, placebo-controlled, triple-blind phase II trial. The randomization will be a 1:1 randomization (experimental arm:control arm). This study will enroll patients with histologically confirmed esophagogastric adenocarcinoma with metastatic disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nintedanib, Fluorouracil and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2016to Jun 2019
Phase
Phase 2
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

  • Histologically confirmed esophagogastric adenocarcinoma with metastatic (M1) disease
  • HER2-negative tumors as per local assessment (according to Rüschoff-Criteria)
  • Presence of at least one evaluable lesion per RECIST v1.1
  • Representative formalin fixed, paraffin embedded tumor blocks or unstained tissue slides, either from the primary tumor or a metastatic lesion, must be available for histological central review of FGFR2 and associated oncogenic pathway and tumor stroma analyses
  • Age 18 years or older
  • ECOG performance status 0-1
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  • Within 7 days prior to treatment start: adequate bone marrow, liver and renal function and coagulation parameters:
  • Neutrophils ≥ 1.5 x 109/L
  • Hemoglobin ≥ 9 g/dL (or ≥ 5.6 mmol/L). Blood transfusions or the administration of hematopoietic growth factors are allowed to achieve these baseline values
  • Platelets ≥ 100 x 109/L. Platelet transfusions or the administration of hematopoietic growth factors are allowed to achieve these baseline values
  • Bilirubin ≤ 1.5 x ULN
  • Patients with Gilbert syndrome and/or bilirubin <2 ULN and normal AST/ALT are eligible
  • SGPT/ALT and SGOT/AST ≤ 2.5 x ULN for patients with liver metastasis
  • SGPT/ALT and SGOT/ AST ≤ 1.5x ULN for patients without liver metastasis
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance/eGFR > 45 ml/min assessed as per local standard method
  • No proteinuria CTCAE grade 2 or greater
  • International normalized ratio (INR) < 2, prothrombin
  • Prothrombin time (PT) and partial thromboplastin time (PTT) >50% of institutional ULN.
  • No Child Pugh B or C hepatic impairment
  • Women of childbearing potential (WOCP): defined as a sexually mature woman who 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally post-menopausal (amenorrhoea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months), must:
  • Have a negative serum pregnancy test within 7 days prior to randomization.
  • Agree to remain sexually abstinent, have a partner who is sterile (i.e., vasectomy), or use two medically effective methods of contraception during dosing and through 90 days after last study treatment. An effective method is the combination of the following (a+b): a. Hormonal method eg, birth control pills; b. Placement of an intrauterine device (IUD) or intrauterine system (fUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/film/ cream/vaginal suppository. This requirement should be followed from screening through 24 weeks after last study treatment.
  • During treatment: Patient should agree to urine pregnancy test to be performed before each treatment;
  • Agree to discontinue treatment in case of pregnancy or positive pregnancy test.
  • Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
  • Sexually active male participants must use a barrier method of contraception (e.g., condom).
  • Before patient registration/randomization, written informed consent must be obtained according to International Council for Harmonisation/Good Clinical Practice (ICH/GCP) and national/local regulations.

Who cannot join

  • Previous chemotherapy for metastatic esophagogastric cancer (Neoadjuvant or adjuvant systemic treatments have to be finished at least (≥) 6 months before study inclusion)
  • History or clinical evidence of central nervous system metastasis or leptomeningeal tumor spread.
  • Other malignant disease in the previous 5 years (apart from basal-cell cancer of the skin or pre-invasive cervical cancer).
  • Other anti-cancer therapy (systemic therapy, radiotherapy, surgery) within 28 days prior to treatment start and while on protocol treatment.
  • Treatment with another investigational agent within 28 days prior to treatment start and while on protocol treatment.
  • Chronic diarrhea or short bowel syndrome
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  • Legal incapacity or limited legal capacity
  • Known hypersensitivity to nintedanib
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration/randomization in the trial.

About this study

Official title: Nintedanib Plus mFOLFOX6 for Previously Untreated Metastatic Esophagogastric Adenocarcinoma (MEGAN): A Randomized, Placebo-controlled, Triple-blind Phase II Study

This is a prospective, multicenter, randomized, placebo-controlled, triple-blind phase II trial. The randomization will be a 1:1 randomization (experimental arm:control arm). This study will enroll patients with histologically confirmed esophagogastric adenocarcinoma with metastatic disease. Patients will have had no previous chemotherapy for metastatic esophagogastric cancer. Patients will receive nintedanib or placebo in combination with mFOLFOX6 (5-Fluorouracil 400 mg/m2 bolus on day 1, 5-Fluorouracil 2400 mg/m2 continuous infusion over 46 hours starting on day 1, Leucovorin 400 mg/m2 on day 1, Oxaliplatin 85 mg/m2 on day 1) via IV infusions every 2 weeks (14 days). Dose modification of nintedanib or placebo and mFOLFOX6 is allowed. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and have not demonstrated disease progression.

The primary objective is to test the hypothesis that progression free survival (PFS) is prolonged in HER2-negative patients with untreated metastatic esophagogastric adenocarcinoma when treated with nintedanib plus modified FOLFOX6 (mFOLFOX6) as compared to placebo plus mFOLFOX6. The analyses will be performed when 124 events for PFS will have been observed in the pooled arms.

Being tested
Nintedanib, Fluorouracil, Leucovorin, Oxaliplatin, Placebo
Medical subject headings
Neoplasm Metastasis

What participants receive

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

Study groups in NCT02856867
Study groupRoleWhat they receive
mFOLFOX6 + NintedanibActive comparatorPatients will receive nintedanib in combination with mFOLFOX6 (5-Fluorouracil 400 mg/m2 bolus on day 1, 5-Fluorouracil 2400 mg/m2 continuous infusion over 46 hours starting on day 1, Leucovorin 400 mg/m2 on day 1, Oxaliplatin 85 mg/m2 on day 1) via IV infusions every 2 weeks (14 days). Dose modification of nintedanib and mFOLFOX6 is allowed. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and have not demonstrated disease progression.
Receives: Drug: Nintedanib; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin
mFOLFOX6 + PlaceboPlacebo comparatorPatients will receive placebo in combination with mFOLFOX6 (5-Fluorouracil 400 mg/m2 bolus on day 1, 5-Fluorouracil 2400 mg/m2 continuous infusion over 46 hours starting on day 1, Leucovorin 400 mg/m2 on day 1, Oxaliplatin 85 mg/m2 on day 1) via IV infusions every 2 weeks (14 days). Dose modification of placebo and mFOLFOX6 is allowed. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and have not demonstrated disease progression.
Receives: Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Placebo

What is being measured

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

  1. Progression-Free Survival

    Measured: 30 months from first patient in

Secondary outcomes (4)

  1. Overall Survival (OS)

    Measured: 5 years from first patient in

  2. Objective Response Rate (ORR, according to RECIST v1.1)

    Measured: 30 months from first patient in

  3. Safety and tolerability (adverse event assessment according to CTCAE v 4.0)

    Measured: 30 months from first patient in

  4. Quality of Life evaluated by questionnaires

    Quality of life will be evaluated with these two questionnaires:

    • EORTC QLQ-30 version 3.0
    • EORTC QLQ-Life gastric-specific

    Measured: 30 months from first patient in

Timeline

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

  1. First posted5 Aug 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionJun 2019 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02856867
Sponsor's protocol ID
EORTC-1418-GITCG
Other IDs
2016-002361-58, 2016
Acronym
MEGAN
Status last verified
May 2017
First submitted
28 Jul 2016
Last updated
9 May 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nintedanib, Fluorouracil and Leucovorin in people with Esophagogastric Adenocarcinoma and Metastatic Disease, run by European Organisation for Research and Treatment of Cancer - EORTC.

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 27 inclusion and 9 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: withdrawn, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (time frame: 30 months from first patient in). 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 NCT02856867.

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 9 May 2017.

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