Phase 2 N=80 Treatment

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

Adenocarcinoma

Bottom Line

View on ClinicalTrials.gov: NCT02213289 ↗

Enrolled (actual)

Serious AEs

46.3%

Results posted

Apr 2021

Primary outcome: Primary: Overall Survival — 15.7; 9.0 months — p=0.0024

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Trastuzumab (Drug); ABT-806 (Drug); Bemarituzumab (Drug); Ramucirumab (Drug); Nivolumab (Drug); Standard cytotherapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	15.7; 9.0	0.0024 sig
SECONDARY Number of Biopsies Leading to an Adverse Event	1; 0	—
SECONDARY Completion of Biopsy and Successful, Molecularly-based Treatment Assignment	134; 23	—
SECONDARY Adverse Event From Serial Biopsy for Second-line Treatment	0; 0	—
SECONDARY Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment	51; 9	—
SECONDARY Adverse Event From Serial Biopsy for Third-line Treatment	0; 0	—
SECONDARY Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment	21; 3	—

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) that targeted drug has on subjects cancer when it is given with standard chemotherapy.

Eligibility Criteria

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 50 mL/min/1.73m2, (for creatinine level above normal)
INR: 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02213289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.