Trial Outcomes & Findings for Taladegib, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Localized Esophageal or Gastroesophageal Junction Cancer (NCT NCT02530437)
NCT ID: NCT02530437
Last Updated: 2023-07-10
Results Overview
The safety data will be summarized using frequencies and percentages by adverse event category, grade and attributions.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 5 weeks
Results posted on
2023-07-10
Participant Flow
Participant milestones
| Measure |
Phase 1 B
Patient received TALADEGIB PO for 38 days, starting on first chemoradiation day.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Taladegib, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Localized Esophageal or Gastroesophageal Junction Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 B
n=7 Participants
Patient received TALADEGIB PO for 38 days, starting on first chemoradiation day.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: Data was not collected
The safety data will be summarized using frequencies and percentages by adverse event category, grade and attributions.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 4 years and 10 monthsPopulation: 6 had surgery, 1 progressed prior to surgery
A pathologic complete response (pathCR) rate of at least 35% (\>= 40% is desirable) will be of interest. The pathCR rate in each of the treatment step will be estimated, along with the 95% confidence interval.
Outcome measures
| Measure |
Phase 1 B
n=7 Participants
Patient received TALADEGIB PO for 38 days, starting on first chemoradiation day.
|
|---|---|
|
Pathologic Complete Response Rate (Phase II)
Complete Response
|
4 Participants
|
|
Pathologic Complete Response Rate (Phase II)
Less than complete response
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to the time of surgeryPopulation: Data was not collected
A linear mixed effect model will be used to assess the change of biomarkers over time. The outcome variable will be biomarker expression level and the covariates will include time, treatment step and time by treatment interaction. The biomarker expression may be log-transformed prior to fit the model in order to satisfy the normality assumption. Also, a logistic regression model will be used for the binary outcome of pathCR, using treatment step, baseline biomarker and the change of biomarker between baseline and at surgery as covariates.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 years and 10 monthsKaplan-Meier method will be used to estimate the probabilities of relapse-free survival.
Outcome measures
| Measure |
Phase 1 B
n=7 Participants
Patient received TALADEGIB PO for 38 days, starting on first chemoradiation day.
|
|---|---|
|
Relapse-free Survival
|
14 months
Interval 2.0 to 28.0
|
SECONDARY outcome
Timeframe: Up to 4 years and 10 monthsKaplan-Meier method will be used to estimate the probabilities of overall survival.
Outcome measures
| Measure |
Phase 1 B
n=7 Participants
Patient received TALADEGIB PO for 38 days, starting on first chemoradiation day.
|
|---|---|
|
Overall Survival
|
27 months
Interval 20.0 to 49.0
|
Adverse Events
Phase 1B
Serious events: 3 serious events
Other events: 7 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Phase 1B
n=7 participants at risk
Patient received TALADEGIB PO for 38 days, starting on first chemoradiation day.
|
|---|---|
|
Infections and infestations
Fever
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Vascular disorders
Ischemia cerebrovascular
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
Other adverse events
| Measure |
Phase 1B
n=7 participants at risk
Patient received TALADEGIB PO for 38 days, starting on first chemoradiation day.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
100.0%
7/7 • Baseline to up to 4 years and 10 months
|
|
General disorders
Fatigue
|
85.7%
6/7 • Baseline to up to 4 years and 10 months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
7/7 • Baseline to up to 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Investigations
Lipase increased
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Investigations
Weight loss
|
100.0%
7/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Dysgeusia
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Skin changes redness
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Dizziness
|
85.7%
6/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
7/7 • Baseline to up to 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Purpura
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Right Wrist Pain
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Esophagitis
|
85.7%
6/7 • Baseline to up to 4 years and 10 months
|
|
Investigations
White blood cell decreased
|
71.4%
5/7 • Baseline to up to 4 years and 10 months
|
|
Investigations
Neutrophil count decreased
|
71.4%
5/7 • Baseline to up to 4 years and 10 months
|
|
Cardiac disorders
Chest Pain
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Abdominal cramping
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
General disorders
Chills
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Vascular disorders
Hypotension
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Eye disorders
Visual changes
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
General disorders
Weakness
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
42.9%
3/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Constipation
|
85.7%
6/7 • Baseline to up to 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Chapped lips
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Vomiting
|
71.4%
5/7 • Baseline to up to 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Mucus
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Headache
|
71.4%
5/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Mucositis oral
|
42.9%
3/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Abdominal pain
|
42.9%
3/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Stomach pain
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
General disorders
Flu like symptoms
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
General disorders
Fever
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Herpes rash
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Ear and labyrinth disorders
Tinnitus
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Abdominal distension
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Abdominal Bloating
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.9%
3/7 • Baseline to up to 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Post-Nasal Drip
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Cardiac disorders
Sinus tachycardia
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Psychiatric disorders
Anxiety
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Dysarthria
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Psychiatric disorders
Difficulty Coping
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Belching
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Right Side Muscle Weakness
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Right Side Hand Weakness
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Odynophagia
|
71.4%
5/7 • Baseline to up to 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity (Right Knee)
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Cardiac disorders
Pleuritic Chest Pain
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity Right Arm
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Skin and subcutaneous tissue disorders
Skin Dermatitis
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Memory impairment
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Ischemia Cerebrovascular
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Lethargy
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Taste Alteration: Metallic Taste
|
42.9%
3/7 • Baseline to up to 4 years and 10 months
|
|
Blood and lymphatic system disorders
Bruises Easily
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Burping
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
General disorders
Non Cardiac Chest Pain
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Substernal Pain
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Nervous system disorders
Light Headedness
|
57.1%
4/7 • Baseline to up to 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Burning Chest Pain
|
28.6%
2/7 • Baseline to up to 4 years and 10 months
|
|
Gastrointestinal disorders
Esophageal Pain
|
42.9%
3/7 • Baseline to up to 4 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
1/7 • Baseline to up to 4 years and 10 months
|
Additional Information
Dr. Jaffer Ajani
University of Texas MD Anderson Cancer Center
Phone: (713) 792-2828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place