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

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ClinicalTrials.gov Identifier: NCT02213289
Recruitment Status : Completed
First Posted : August 11, 2014
Results First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adenocarcinoma
Interventions Drug: Trastuzumab
Drug: ABT-806
Drug: Bemarituzumab
Drug: Ramucirumab
Drug: Nivolumab
Drug: Standard cytotherapy
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description

For patients with monoclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus Trastuzumab.

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

Of note, while the protocol section describes these tailored therapies, the efficacy evaluation was based on pooling these treatments into a combined "personalized treatment strategy" group and comparing with historical controls. Therefore this "arm" includes all such patients with monoclonal antibodies available.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)

Of note, this arm includes patients without monoclonal antibodies available, for whom no personalized treatment strategy was available. The intent of the protocol was NOT to compare this arm with arm 1.

Period Title: Overall Study
Started 68 12
Immuno-oncology 5 0
HER2 Amplified 16 0
EGFR Amplified 8 0
FGFR2 Amplified 1 0
MAPK/PIK3CA Aberrant 20 0
EGFR Expressing 9 0
All Negative 9 0
Other (Non-ITT) 0 12
Completed 68 12
Not Completed 0 0
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy Total
Hide Arm/Group Description

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive patients received standard cytoptherapy plus Nivolumab

HER2 amplified patients received standard cytotherapy plus Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available, therapy was standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line) Total of all reporting groups
Overall Number of Baseline Participants 68 12 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants 12 participants 80 participants
61
(28 to 81)
61
(39 to 77)
61
(28 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 12 participants 80 participants
Female
15
  22.1%
1
   8.3%
16
  20.0%
Male
53
  77.9%
11
  91.7%
64
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 12 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.9%
0
   0.0%
2
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  10.3%
0
   0.0%
7
   8.8%
White
57
  83.8%
11
  91.7%
68
  85.0%
More than one race
2
   2.9%
1
   8.3%
3
   3.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants 12 participants 80 participants
68 12 80
1.Primary Outcome
Title Overall Survival
Hide Description Time from enrollment to death from any cause.
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description:

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Overall Number of Participants Analyzed 68 12
Median (95% Confidence Interval)
Unit of Measure: months
15.7
(13.4 to 17.7)
9.0
(4.6 to 20.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ITT-PTS: Personalized Treatment Strategy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method One-sided Z-test
Comments This was a test of whether the observed 1-year survival rate was significantly different from historical 50% rate.
2.Secondary Outcome
Title Number of Biopsies Leading to an Adverse Event
Hide Description 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).
Time Frame 1 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Unit of analysis is the biopsy. Each patient had two biopsies, one of the primary tumor and one of a metastatic site.
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description:

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Overall Number of Participants Analyzed 68 12
Overall Number of Units Analyzed
Type of Units Analyzed: Biopsies
136 24
Measure Type: Number
Unit of Measure: biopsies
1 0
3.Secondary Outcome
Title Completion of Biopsy and Successful, Molecularly-based Treatment Assignment
Hide Description 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).
Time Frame Up to 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Unit of analysis is the biopsy. Two biopsies were performed per patient, one of the primary tumor and one from a metastatic site.
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description:

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Overall Number of Participants Analyzed 68 12
Overall Number of Units Analyzed
Type of Units Analyzed: Biopsies
136 24
Measure Type: Number
Unit of Measure: biopsies
134 23
4.Secondary Outcome
Title Adverse Event From Serial Biopsy for Second-line Treatment
Hide Description Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)
Time Frame Up to 60 Months
Hide Outcome Measure Data
Hide Analysis Population Description
This includes subset of patients administered second-line treatment
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description:

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Overall Number of Participants Analyzed 61 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Completion of Serial Biopsy for Second Line Therapy and Successful, Molecularly-based Treatment Assignment
Hide Description 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).
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
This includes subset of patients administered second-line treatment
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description:

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Overall Number of Participants Analyzed 61 11
Measure Type: Count of Participants
Unit of Measure: Participants
51
  83.6%
9
  81.8%
6.Secondary Outcome
Title Adverse Event From Serial Biopsy for Third-line Treatment
Hide Description Number of participants with adverse events from serial biopsies of progressing metastatic disease sites (liver, lung, lymph node, peritoneum/carcinomatosis)
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
This includes subset of patients administered third-line treatment
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description:

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patient including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806.

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Overall Number of Participants Analyzed 25 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Completion of Serial Biopsy for Third Line Therapy and Successful, Molecularly-based Treatment Assignment
Hide Description 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).
Time Frame Up to 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
This includes subset of patients administered third-line treatment
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description:

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus received Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plous ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Overall Number of Participants Analyzed 25 3
Measure Type: Count of Participants
Unit of Measure: Participants
21
  84.0%
3
 100.0%
8.Other Pre-specified Outcome
Title First-line Progression-free Survival
Hide Description 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.
Time Frame Up to 60 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description:

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus Trastuzumab

EGFR amplified patients received standard cytotherapy plus ABT-806

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Overall Number of Participants Analyzed 68 12
Median (95% Confidence Interval)
Unit of Measure: months
8.2
(7.3 to 9.6)
6.7
(2.9 to 10.6)
9.Other Pre-specified Outcome
Title Objective Response to First Line Therapy
Hide Description 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.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description:

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus Trastuzumab.

EGFR amplified patients received standard cytotherapy plus ABT-806.

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available. These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
Overall Number of Participants Analyzed 54 10
Measure Type: Count of Participants
Unit of Measure: Participants
40
  74.1%
4
  40.0%
Time Frame 60 months
Adverse Event Reporting Description Molecular arms/groups are combined for this analysis because the intent of the study was to compare the overall strategy of molecular-based treatment vs. not undertaking molecular-based therapy. Thus the number of patients with adverse events over the potential three lines of therapy is reported.
 
Arm/Group Title ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Hide Arm/Group Description

For patients with monclonal antibiodies available, initial therapy was tailored based on biomarker profile as follows:

Immuno-oncology patients including PD-L1 IHC combined positivity score >10, high microsatellite instability, tumor mutation burden >15 mutations/megabase, and/or Epstein-Barr virus positive received standard cytotherapy plus Nivolumab.

HER2 amplified patients received standard cytotherapy plus Trastuzumab.

EGFR amplified patients received standard cytotherapy plus ABT-806..

FGFR2 amplified patients received standard cytotherapy plus Bemarituzumab.

MAPK/PIK3CA aberrant patients received standard cytotherapy plus Ramucirumab.

EGFR expressing patients received standard cytotherapy plus ABT 806.

All negative patients received standard cytotherapy plus Ramucirumab.

For patients without monoclonal antibodies available.These patients received standard cytotherapy consisting of FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
All-Cause Mortality
ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   56/68 (82.35%)   11/12 (91.67%) 
Hide Serious Adverse Events
ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   29/68 (42.65%)   8/12 (66.67%) 
Blood and lymphatic system disorders     
Anemia * 1  2/68 (2.94%)  0/12 (0.00%) 
Blood and lymphatic system disorders - Other * 1  1/68 (1.47%)  0/12 (0.00%) 
Febrile neutropenia * 1  1/68 (1.47%)  0/12 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/68 (1.47%)  0/12 (0.00%) 
Ascites * 1  1/68 (1.47%)  1/12 (8.33%) 
Diarrhea * 1  2/68 (2.94%)  0/12 (0.00%) 
Dysphagia * 1  4/68 (5.88%)  0/12 (0.00%) 
Esophageal obstruction * 1  1/68 (1.47%)  0/12 (0.00%) 
Esophageal perforation * 1  1/68 (1.47%)  0/12 (0.00%) 
Esophagitis * 1  1/68 (1.47%)  0/12 (0.00%) 
Gastrointestinal disorders - Other * 1  1/68 (1.47%)  0/12 (0.00%) 
Gastroparesis * 1  1/68 (1.47%)  0/12 (0.00%) 
Nausea * 1  2/68 (2.94%)  2/12 (16.67%) 
Small intestinal obstruction * 1  1/68 (1.47%)  0/12 (0.00%) 
Upper gastrointestinal hemorrhage * 1  1/68 (1.47%)  0/12 (0.00%) 
Vomiting * 1  1/68 (1.47%)  2/12 (16.67%) 
General disorders     
Death NOS * 1  1/68 (1.47%)  1/12 (8.33%) 
Edema limbs * 1  0/68 (0.00%)  1/12 (8.33%) 
Fatigue * 1  1/68 (1.47%)  0/12 (0.00%) 
Fever * 1  2/68 (2.94%)  1/12 (8.33%) 
Non-cardiac chest pain * 1  2/68 (2.94%)  1/12 (8.33%) 
Infections and infestations     
Catheter related infection * 1  1/68 (1.47%)  0/12 (0.00%) 
Pelvic infection * 1  1/68 (1.47%)  0/12 (0.00%) 
Phlebitis infective * 1  1/68 (1.47%)  0/12 (0.00%) 
Sepsis * 1  5/68 (7.35%)  1/12 (8.33%) 
Urinary tract infection * 1  2/68 (2.94%)  0/12 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  1/68 (1.47%)  0/12 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  1/68 (1.47%)  0/12 (0.00%) 
Aspartate aminotransferase increased * 1  1/68 (1.47%)  0/12 (0.00%) 
Blood bilirubin increased * 1  0/68 (0.00%)  1/12 (8.33%) 
Platelet count decreased * 1  1/68 (1.47%)  0/12 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/68 (1.47%)  0/12 (0.00%) 
Hypokalemia * 1  1/68 (1.47%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/68 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
Seizure * 1  1/68 (1.47%)  0/12 (0.00%) 
Stroke * 1  2/68 (2.94%)  0/12 (0.00%) 
Syncope * 1  1/68 (1.47%)  0/12 (0.00%) 
Psychiatric disorders     
Confusion * 1  0/68 (0.00%)  1/12 (8.33%) 
Delirium * 1  1/68 (1.47%)  0/12 (0.00%) 
Renal and urinary disorders     
Renal and urinary disorders - Other * 1  1/68 (1.47%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  4/68 (5.88%)  0/12 (0.00%) 
Cough * 1  0/68 (0.00%)  1/12 (8.33%) 
Dyspnea * 1  1/68 (1.47%)  2/12 (16.67%) 
Pneumonitis * 1  1/68 (1.47%)  0/12 (0.00%) 
Surgical and medical procedures     
Surgical and medical procedures - Other * 1  1/68 (1.47%)  0/12 (0.00%) 
Vascular disorders     
Thromboembolic event * 1  1/68 (1.47%)  0/12 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ITT-PTS: Personalized Treatment Strategy Non-ITT: Standard Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   68/68 (100.00%)   12/12 (100.00%) 
Blood and lymphatic system disorders     
Anemia * 1  20/68 (29.41%)  1/12 (8.33%) 
Febrile neutropenia * 1  2/68 (2.94%)  1/12 (8.33%) 
Cardiac disorders     
Leukocytosis * 1  2/68 (2.94%)  1/12 (8.33%) 
Congenital, familial and genetic disorders     
Chest pain - cardiac * 1  3/68 (4.41%)  1/12 (8.33%) 
Eye disorders     
Blurred vision * 1  1/68 (1.47%)  1/12 (8.33%) 
Gastrointestinal disorders     
Abdominal distenstion * 1  4/68 (5.88%)  1/12 (8.33%) 
Abdominal pain * 1  37/68 (54.41%)  7/12 (58.33%) 
Ascites * 1  8/68 (11.76%)  2/12 (16.67%) 
Bloating * 1  7/68 (10.29%)  2/12 (16.67%) 
Colitis * 1  5/68 (7.35%)  1/12 (8.33%) 
Constipation * 1  32/68 (47.06%)  4/12 (33.33%) 
Diarrhea * 1  43/68 (63.24%)  5/12 (41.67%) 
Dyspepsia/heartburn * 1  5/68 (7.35%)  1/12 (8.33%) 
Dysphagia, esophagitis, odynophagia * 1  27/68 (39.71%)  5/12 (41.67%) 
Facial pain * 1  0/68 (0.00%)  1/12 (8.33%) 
Fatigue * 1  64/68 (94.12%)  9/12 (75.00%) 
Fever * 1  17/68 (25.00%)  3/12 (25.00%) 
Gastroesophagial reflux disease * 1  13/68 (19.12%)  1/12 (8.33%) 
Gastrointestinal disorders - Other * 1  4/68 (5.88%)  3/12 (25.00%) 
Gastrointestinal pain * 1  1/68 (1.47%)  1/12 (8.33%) 
hemorrhoidal hemorrhage * 1  1/68 (1.47%)  1/12 (8.33%) 
Intra-abdominal hemorrhage * 1  0/68 (0.00%)  1/12 (8.33%) 
Mucositis oral * 1  13/68 (19.12%)  0/12 (0.00%) 
Nausea * 1  52/68 (76.47%)  10/12 (83.33%) 
Periodontal disease * 1  2/68 (2.94%)  1/12 (8.33%) 
Vomiting * 1  31/68 (45.59%)  5/12 (41.67%) 
General disorders     
Chills * 1  6/68 (8.82%)  0/12 (0.00%) 
Edema limbs * 1  20/68 (29.41%)  4/12 (33.33%) 
Flu like symptoms * 1  1/68 (1.47%)  1/12 (8.33%) 
General disorders and administration site conditions - Other * 1  6/68 (8.82%)  3/12 (25.00%) 
Localized edema * 1  6/68 (8.82%)  1/12 (8.33%) 
Non-cardiac chest pain * 1  8/68 (11.76%)  2/12 (16.67%) 
Pain * 1  20/68 (29.41%)  4/12 (33.33%) 
Infections and infestations     
Urinary track infection * 1  4/68 (5.88%)  1/12 (8.33%) 
Injury, poisoning and procedural complications     
Bruising * 1  2/68 (2.94%)  1/12 (8.33%) 
Fall * 1  5/68 (7.35%)  2/12 (16.67%) 
Fracture * 1  1/68 (1.47%)  1/12 (8.33%) 
Investigations     
Alanine aminotransferase increased * 1  3/68 (4.41%)  3/12 (25.00%) 
Aspartate aminotransferase increased * 1  4/68 (5.88%)  3/12 (25.00%) 
Blood bilirubin increased * 1  7/68 (10.29%)  1/12 (8.33%) 
Neutrophil count decreased * 1  8/68 (11.76%)  0/12 (0.00%) 
Platelet count decreases * 1  14/68 (20.59%)  1/12 (8.33%) 
Sinusitis * 1  2/68 (2.94%)  1/12 (8.33%) 
Upper respiratory infection * 1  4/68 (5.88%)  0/12 (0.00%) 
Weight loss * 1  21/68 (30.88%)  5/12 (41.67%) 
Metabolism and nutrition disorders     
Anorexia * 1  41/68 (60.29%)  7/12 (58.33%) 
Hyperkalemia * 1  2/68 (2.94%)  1/12 (8.33%) 
Hypokalemia * 1  9/68 (13.24%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  5/68 (7.35%)  0/12 (0.00%) 
Back pain * 1  20/68 (29.41%)  1/12 (8.33%) 
Flank pain * 1  4/68 (5.88%)  1/12 (8.33%) 
Generalized muscle weakness * 1  7/68 (10.29%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorder - Other * 1  1/68 (1.47%)  1/12 (8.33%) 
Neck pain * 1  5/68 (7.35%)  0/12 (0.00%) 
Pain in extremity * 1  6/68 (8.82%)  2/12 (16.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other * 1  0/68 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
Dizzines * 1  14/68 (20.59%)  1/12 (8.33%) 
Dysgeusia * 1  26/68 (38.24%)  4/12 (33.33%) 
Headache * 1  10/68 (14.71%)  1/12 (8.33%) 
Neuropathy-sensory * 1  58/68 (85.29%)  8/12 (66.67%) 
Paresthesia * 1  19/68 (27.94%)  4/12 (33.33%) 
Presyncope * 1  1/68 (1.47%)  1/12 (8.33%) 
Tremor * 1  2/68 (2.94%)  1/12 (8.33%) 
Psychiatric disorders     
Anxiety * 1  0/68 (0.00%)  1/12 (8.33%) 
Hallucinations * 1  0/68 (0.00%)  1/12 (8.33%) 
Insomnia * 1  8/68 (11.76%)  4/12 (33.33%) 
Mood aleration - depression * 1  10/68 (14.71%)  2/12 (16.67%) 
Renal and urinary disorders     
Hematuria * 1  4/68 (5.88%)  0/12 (0.00%) 
Proteinuria * 1  4/68 (5.88%)  0/12 (0.00%) 
Renal colic * 1  1/68 (1.47%)  1/12 (8.33%) 
Urinary incontinence * 1  3/68 (4.41%)  1/12 (8.33%) 
Urinary retention * 1  0/68 (0.00%)  1/12 (8.33%) 
Urinary tract obstruction * 1  2/68 (2.94%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  1/68 (1.47%)  1/12 (8.33%) 
Cough * 1  16/68 (23.53%)  5/12 (41.67%) 
Dyspnea * 1  17/68 (25.00%)  2/12 (16.67%) 
Epistaxis * 1  10/68 (14.71%)  1/12 (8.33%) 
Hoarseness * 1  0/68 (0.00%)  1/12 (8.33%) 
Hypoxia * 1  4/68 (5.88%)  0/12 (0.00%) 
Nasal congestion * 1  5/68 (7.35%)  0/12 (0.00%) 
Pleural effusion * 1  8/68 (11.76%)  0/12 (0.00%) 
Pneumonitis * 1  2/68 (2.94%)  1/12 (8.33%) 
Sore throat * 1  4/68 (5.88%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  7/68 (10.29%)  1/12 (8.33%) 
Dry skin * 1  4/68 (5.88%)  1/12 (8.33%) 
Palmar-plantar erythrodysesthesia synrome * 1  6/68 (8.82%)  1/12 (8.33%) 
Rash acneiform * 1  8/68 (11.76%)  1/12 (8.33%) 
Rash maculo-papular * 1  6/68 (8.82%)  1/12 (8.33%) 
Vascular disorders     
Hypertension * 1  10/68 (14.71%)  1/12 (8.33%) 
Hypotension * 1  7/68 (10.29%)  1/12 (8.33%) 
Thromboembolic event * 1  9/68 (13.24%)  1/12 (8.33%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Catenacci, MD
Organization: University of Chicago
Phone: 2-1000
EMail: dcatenac@bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02213289    
Other Study ID Numbers: IRB14-0141
First Submitted: August 1, 2014
First Posted: August 11, 2014
Results First Submitted: January 29, 2021
Results First Posted: April 8, 2021
Last Update Posted: April 8, 2021