Trial Outcomes & Findings for Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study (NCT NCT01949870)
NCT ID: NCT01949870
Last Updated: 2016-05-13
Results Overview
The number of dose-limiting toxicities in selumetinib in combination with cisplatin and gemcitabine
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
The first cycle with selumetinib until Day 1 of Cycle 2 of combination dosing
Results posted on
2016-05-13
Participant Flow
The study was conducted at 2 study centres in Japan between October 2013 and August 2014.
Participant milestones
| Measure |
Selumetinib+ Cisplatin + Gemcitabine
Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
Received Treatment
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Selumetinib+ Cisplatin + Gemcitabine
Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8
|
|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Study termination
|
1
|
|
Overall Study
Eligibility requirements not fulfilled
|
2
|
Baseline Characteristics
Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
Baseline characteristics by cohort
| Measure |
Selumetinib+ Cisplatin + Gemcitabine
n=4 Participants
Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8
|
|---|---|
|
Age, Customized
<50 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
>=50 to < 65 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The first cycle with selumetinib until Day 1 of Cycle 2 of combination dosingPopulation: Evaluable = completed at least 75% of planned daily doses of selumetinib at least 50% of planned dose of cisplatin/gemcitabine planned on Cycle 1 Day 8 (therefore, in total with Cycle 1 Day 1, at least 75 % of planned dose is given in Cycle 1) and has enough information to be assessed for the combination regimen dose escalation.
The number of dose-limiting toxicities in selumetinib in combination with cisplatin and gemcitabine
Outcome measures
| Measure |
Selumetinib+ Cisplatin + Gemcitabine
n=3 Participants
Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8
|
|---|---|
|
The Number of Dose-limiting Toxicities
Yes
|
0 Participants
|
|
The Number of Dose-limiting Toxicities
No
|
3 Participants
|
Adverse Events
Selumetinib+ Cisplatin + Gemcitabine
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Selumetinib+ Cisplatin + Gemcitabine
n=4 participants at risk
Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8
|
|---|---|
|
Hepatobiliary disorders
Cholangitis
|
25.0%
1/4 • Number of events 1 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
Other adverse events
| Measure |
Selumetinib+ Cisplatin + Gemcitabine
n=4 participants at risk
Selumetinib (25 mg bd)
For each 21-day cycle:
Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
2/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
General disorders
Fatigue
|
50.0%
2/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
General disorders
Pyrexia
|
50.0%
2/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
General disorders
Oedema
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Investigations
Platelet count decreased
|
100.0%
4/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Investigations
Neutrophil count decreased
|
75.0%
3/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Investigations
White blood cell count decreased
|
75.0%
3/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Investigations
Lymphocyte count decreased
|
50.0%
2/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • AEs were collected throughout the study, from informed consent until the end of the followup period (28 days after last dose).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60