Trial Outcomes & Findings for Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen (NCT NCT01365130)

NCT ID: NCT01365130

Last Updated: 2019-04-12

Results Overview

Response will be assessed via RECIST 1.1 criteria

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

every three cycles approx every 63 days

Results posted on

2019-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Real Drug patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Real Drug patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression
Overall Study Progression/worsening of Dx prior to txt	2

Baseline Characteristics

Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Real Drug n=13 Participants patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression
Age, Continuous	67 years STANDARD_DEVIATION 7.9 • n=99 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Region of Enrollment United States	13 participants n=99 Participants

PRIMARY outcome

Timeframe: every three cycles approx every 63 days

Response will be assessed via RECIST 1.1 criteria

Outcome measures

Outcome measures
Measure	Real Drug n=13 Participants patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression
Number of Patients Without Progression at 3 Months	11 participants

SECONDARY outcome

Timeframe: During treatment and through 30 days post treatment, approximately 7 months

Population: Number of patients who experienced a toxicity on the trial. Not all toxicities may be related to study treatment.

CTCAE version 4. It is noted that the time frame was approximately 7 months, taking into account the total amount of treatment patients received on this trial.

Outcome measures

Outcome measures
Measure	Real Drug n=13 Participants patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression
Number of Patients Experienced a Toxicity Associated With Cabazitaxel for Patients With Metastatic Gastroesophageal Adenocarcinomas That Have Progressed After at Least One Line of Therapy for Metastatic Disease.	13 Participants

Adverse Events

Real Drug

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Real Drug n=13 participants at risk patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression
Investigations Diarrhea, nausea, vomiting	7.7% 1/13 • Number of events 1
Investigations neutropenia, fever , weakness	7.7% 1/13 • Number of events 1
Investigations pneumonia and anemia	7.7% 1/13 • Number of events 1
Investigations pleural effusion	7.7% 1/13 • Number of events 1
Investigations neutopenia, WBC, febrile neutropenia and fever	7.7% 1/13 • Number of events 1

Other adverse events

Other adverse events
Measure	Real Drug n=13 participants at risk patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression
Blood and lymphatic system disorders Neutropenia	23.1% 3/13 • Number of events 3
Investigations abd pain	30.8% 4/13 • Number of events 4
Investigations Alk	7.7% 1/13 • Number of events 1
Investigations Anemia	92.3% 12/13 • Number of events 12
Investigations barret esophagus	7.7% 1/13 • Number of events 1
Investigations bone pain	7.7% 1/13 • Number of events 1
Investigations Ca	15.4% 2/13 • Number of events 2
Investigations cellulitis	7.7% 1/13 • Number of events 1
Investigations creatinine	7.7% 1/13 • Number of events 1
Investigations Diarrhea	38.5% 5/13 • Number of events 5
Investigations diverticulitis	7.7% 1/13 • Number of events 1
Investigations dizziness	7.7% 1/13 • Number of events 1
Investigations dry mouth	7.7% 1/13 • Number of events 1
Investigations edema	7.7% 1/13 • Number of events 1
Investigations erythema	7.7% 1/13 • Number of events 1
Investigations fatigue	38.5% 5/13 • Number of events 5
Investigations glucose	46.2% 6/13 • Number of events 6
Investigations Headache	7.7% 1/13 • Number of events 1
Investigations heartburn	7.7% 1/13 • Number of events 1
Investigations hypoalbumin	53.8% 7/13 • Number of events 7
Investigations hypokalemia	15.4% 2/13 • Number of events 2
Investigations LFTs	15.4% 2/13 • Number of events 2
Investigations lymphopenia	15.4% 2/13 • Number of events 2
Investigations Hyponatremia	7.7% 1/13 • Number of events 1
Investigations nausea	46.2% 6/13 • Number of events 6
Investigations pain	7.7% 1/13 • Number of events 1
Investigations proteinuria	7.7% 1/13 • Number of events 1
Investigations RBC	23.1% 3/13 • Number of events 3
Investigations rhinitis	7.7% 1/13 • Number of events 1
Investigations SOB	7.7% 1/13 • Number of events 1
Investigations cough	7.7% 1/13 • Number of events 1
Investigations Thrombocytopenia	38.5% 5/13 • Number of events 5
Investigations Thursh	7.7% 1/13 • Number of events 1
Investigations Typhilitis	7.7% 1/13 • Number of events 1
Investigations vomiting	23.1% 3/13 • Number of events 3
Investigations WBC	23.1% 3/13 • Number of events 3
Investigations weakness	7.7% 1/13 • Number of events 1
Investigations wt loss/anorexia	15.4% 2/13 • Number of events 2

Additional Information

Howard Safran, MD

BrUOG

Phone: 4018633000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place