- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02213289
PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression
PANGEA: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: ITT-PTS: Personalized Treatment Strategy (Immuno-oncology)
For 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. |
Nivolumab
Andre navne:
FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
|
Eksperimentel: ITT-PTS: Personalized Treatment Strategy (HER2 amplified)
HER2 amplified.
These patients received standard cytotherapy plus Trastuzumab.
|
Trastuzumab
Andre navne:
FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
|
Eksperimentel: ITT-PTS: Personalized Treatment Strategy (EFGR amplified)
EGFR amplified.
These patients received ABT-806.
|
FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
ABT-806
|
Eksperimentel: ITT-PTS: Personalized Treatment Strategy (FGFR2 amplified)
FGFR2 amplified.
These patients received standard cytotherapy plus Bemarituzumab.
|
FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Bemarituzumab
|
Eksperimentel: ITT-PTS: Personalized Treatment Strategy (MAPK/PIK3CA aberrant)
MAPK/PIK3CA aberrant.
These patients received standard cytotherapy plus Ramucirumab.
|
FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Ramucirumab
Andre navne:
|
Eksperimentel: ITT-PTS: Personalized Treatment Strategy (EGFR expressing)
EGFR expressing.
These patients received standard cytotherapy plus ABT 806.
|
FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
ABT-806
|
Eksperimentel: ITT-PTS: Personalized Treatment Strategy (All negative)
All negative.
These patients received standard cytotherapy plus Ramucirumab.
|
FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Ramucirumab
Andre navne:
|
Andet: Non-ITT: Standard Therapy
Patients without monoclonal antibodies available received standard cytotherapy.
|
FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall Survival
Tidsramme: Up to 60 months
|
Time from enrollment to death from any cause.
|
Up to 60 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Biopsies Leading to an Adverse Event
Tidsramme: 1 Month
|
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).
|
1 Month
|
Completion of Biopsy and Successful, Molecularly-based Treatment Assignment
Tidsramme: Up to 1 month
|
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).
|
Up to 1 month
|
Adverse Event From Serial Biopsy for Second-line Treatment
Tidsramme: Up to 60 Months
|
Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)
|
Up to 60 Months
|
Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment
Tidsramme: Up to 60 months
|
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).
|
Up to 60 months
|
Adverse Event From Serial Biopsy for Third-line Treatment
Tidsramme: Up to 60 months
|
Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)
|
Up to 60 months
|
Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment
Tidsramme: Up to 60 months
|
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).
|
Up to 60 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
First-line Progression-free Survival
Tidsramme: Up to 60 Months
|
Time from enrollment to progression or death during first-line treatment.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
|
Up to 60 Months
|
Objective Response to First Line Therapy
Tidsramme: Up to 6 months
|
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
|
Up to 6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Daniel Catenacci, MD, University of Chicago
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB14-0141
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