AzTrials
AzTrials

AdenocarcinomaPhase 2NCT02213289

PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression

A Phase 2 study testing Trastuzumab, ABT-806 and Bemarituzumab in people with Adenocarcinoma, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine if doctors can use the results of special tests of subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a specific drug that is targeted to work against that abnormality (called molecular profiling) and to see what effects (good and/or bad)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma
What is being tested?
Trastuzumab, ABT-806 and Bemarituzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
20 Jan 2015to 20 Aug 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 metastatic gastric or esophagogastric junction (type I,II,III Siewert) adenocarcinoma
  • Newly-diagnosed chemo-naïve or recurrent after curative-intent surgery
  • >6 months after completion of adjuvant therapy (including chemotherapy and/or radiotherapy)
  • No prior treatment with any targeted agent
  • Patients who have started first line mFOLFOX6 therapy (+/-trastuzumab for HER2 amplified tumors) may be considered for trial participation if they have received no more than 4 doses of therapy at the time of consent and screening.
  • Measurable metastatic disease by RECIST criteria,
Show all 27Show fewer
  • Must be amenable to ultrasound or CT-guided biopsy of one metastatic lesion
  • Peritoneal disease as the sole site of occult metastasis or presenting as malignant ascites is acceptable if a cell block of tumor cells can be obtained showing >20% viable tumor cells.
  • ECOG PS 0,1
  • Age > 18 years
  • Patients must have normal organ and marrow function as defined below:
  • granulocytes >1,2500/mcL
  • platelets >100,000/mcL
  • total bilirubin < 1.5 x ULN, <1.8 x ULN with liver metastases
  • AST(SGOT)/ALT(SGPT) <2.5 X ULN without liver metastases; <5 X ULN with liver metastases
  • creatinine within normal institutional limits (<1.5) OR
  • creatinine clearance >50 mL/min/1.73m2, (for creatinine level above normal)
  • INR: < 1.5 (patients on warfarin need to be converted to LMWH during study participation to be eligible)
  • Consent to baseline metastatic and progressive disease biopsy (of metastatic/progressing lesion) for enabling biomarker assessment and treatment assignment (at each time point - baseline, PD1, PD2, PD3) as well as for correlative studies.
  • Consent to baseline and serial blood draws for plasma/serum/whole blood banking for correlative studies
  • Ability to understand and the willingness to sign a written informed consent document and consent to the serial nature of the proposed PANGEA treatment with first, second and third line therapy as tolerated.
  • Ability to comply with requirements of the protocol, as assessed by the investigator by the patient signing the consent form.
  • If history of exposure to anthracyclines during perioperative treatment, the following cumulative doses of anthracyclines must be less than:
  • Epirubicin < 720 mg/m2 Doxorubicin or liposomal doxorubicin < 360 mg/m2 Mitoxantrone > 120 mg/m2 and idarubicin > 90 mg/m2 If more than one anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin.
  • Cardiac Ejection Fraction >50% (for HER2+ patients) as assessed by echocardiogram, MUGA scan, or cardiac MRI
  • Willingness to use effective and reliable methods of contraception (For appropriate methods of contraception considered acceptable see Appendix B).
  • Both men and women and members of all races and ethnic groups are eligible for this trial.

Who cannot join

  • No CVA within 6 months, no recent MI within 6 months
  • No currently active second malignancy
  • No uncontrolled intercurrent illness or infection
  • No peripheral edema > grade 2 at baseline.
  • No peripheral neuropathy > grade 2 at baseline.
  • No diarrhea > grade 2 at baseline.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: PANGEA: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma

The purpose of this study is to determine if doctors can use the results of special tests of subjects tumor tissue, that will look for specific abnormalities in the tumor, to choose a specific drug that is targeted to work against that abnormality (called molecular profiling) and to see what effects (good and/or bad) that targeted drug has on subjects cancer when it is given with standard chemotherapy.

Conditions
Adenocarcinoma
Being tested
Trastuzumab, ABT-806, Bemarituzumab, Ramucirumab, Nivolumab
Keywords
Gastric, Esophagogastric
Medical subject headings
Adenocarcinoma

What participants receive

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

  • TrastuzumabDrug

    Also called Herceptin®

    Trastuzumab

  • ABT-806Drug

    ABT-806

  • BemarituzumabDrug

    Bemarituzumab

  • RamucirumabDrug

    Also called Cyramza

    Ramucirumab

  • NivolumabDrug

    Also called Opdivo

    Nivolumab

  • Standard cytotherapyDrug

    FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)

Study groups in NCT02213289
Study groupRoleWhat they receive
ITT-PTS: Personalized Treatment Strategy (Immuno-oncology)ExperimentalFor patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows: Immuno-oncology included PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations per megabase, and/or Epstein-Barr virus positive. These patients received standard cytotherapy plus Nivolumab.
Receives: Drug: Nivolumab; Drug: Standard cytotherapy
ITT-PTS: Personalized Treatment Strategy (HER2 amplified)ExperimentalHER2 amplified. These patients received standard cytotherapy plus Trastuzumab.
Receives: Drug: Trastuzumab; Drug: Standard cytotherapy
ITT-PTS: Personalized Treatment Strategy (EFGR amplified)ExperimentalEGFR amplified. These patients received ABT-806.
Receives: Drug: ABT-806; Drug: Standard cytotherapy
ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified)ExperimentalFGFR2 amplified. These patients received standard cytotherapy plus Bemarituzumab.
Receives: Drug: Bemarituzumab; Drug: Standard cytotherapy
ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant)ExperimentalMAPK/PIK3CA aberrant. These patients received standard cytotherapy plus Ramucirumab.
Receives: Drug: Ramucirumab; Drug: Standard cytotherapy
ITT-PTS: Personalized Treatment Strategy (EGFR expressing)ExperimentalEGFR expressing. These patients received standard cytotherapy plus ABT 806.
Receives: Drug: ABT-806; Drug: Standard cytotherapy
ITT-PTS: Personalized Treatment Strategy (All negative)ExperimentalAll negative. These patients received standard cytotherapy plus Ramucirumab.
Receives: Drug: Ramucirumab; Drug: Standard cytotherapy
Non-ITT: Standard TherapyOtherPatients without monoclonal antibodies available received standard cytotherapy.
Receives: Drug: Standard cytotherapy

What is being measured

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

  1. Overall Survival

    Time from enrollment to death from any cause.

    Measured: Up to 60 months

Secondary outcomes (6)

  1. Number of Biopsies Leading to an Adverse Event

    Number of biopsies leading to an adverse event of the total undergoing baseline biopsies of a primary and metastatic disease site (liver, lung, lymph node, peritoneum/carcinomatosis).

    Measured: 1 Month

  2. Completion of Biopsy and Successful, Molecularly-based Treatment Assignment

    Completion of biopsies with successful assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).

    Measured: Up to 1 month

  3. Adverse Event From Serial Biopsy for Second-line Treatment

    Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)

    Measured: Up to 60 Months

  4. Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment

    Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).

    Measured: Up to 60 months

  5. Adverse Event From Serial Biopsy for Third-line Treatment

    Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)

    Measured: Up to 60 months

  6. Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment

    Completion of biopsy with successful treatment assignment per the treatment algorithm. Biomarker profile assays included next generation sequencing (NGS). EGFR expression was performed by selected-reaction-monitoring mass spectrometry (SRM-MS).

    Measured: Up to 60 months

Timeline

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

  1. First posted11 Aug 2014 (estimated)
  2. Study start20 Jan 2015
  3. Primary completion1 Feb 2020
  4. Study completion20 Aug 2020

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02213289
Sponsor's protocol ID
IRB14-0141
Status last verified
Mar 2021
First submitted
1 Aug 2014
Last updated
8 Apr 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab, ABT-806 and Bemarituzumab in people with Adenocarcinoma, run by University of Chicago at 1 site in United States.

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 6 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: finished, as of the sponsor's last update on 8 Apr 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 United States. 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 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?

Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (time frame: Up to 60 months). 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 NCT02213289.

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 8 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in