Trial Outcomes & Findings for Study of Mogamulizumab + Docetaxel in Subjects With Non-small Cell Lung Cancer (NCT NCT02358473)
NCT ID: NCT02358473
Last Updated: 2024-09-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Screening through 90 days after the last dose of study medication
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Mogamulizumab + Docetaxel
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Mogamulizumab + Docetaxel
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Overall Study
Disease Progession
|
6
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Study of Mogamulizumab + Docetaxel in Subjects With Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Mogamulizumab + Docetaxel
n=13 Participants
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening through 90 days after the last dose of study medicationOutcome measures
| Measure |
Mogamulizumab + Docetaxel
n=13 Participants
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Number of Subjects Reporting Adverse Events
|
13 Participants
|
PRIMARY outcome
Timeframe: Screening through 90 days after the last dose of study medicationOutcome measures
| Measure |
Mogamulizumab + Docetaxel
n=13 Participants
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Number of Subjects Reporting Serious Adverse Events
|
6 Participants
|
PRIMARY outcome
Timeframe: First dose of study medications through 4 weeks after the last dose of study medicationOutcome measures
| Measure |
Mogamulizumab + Docetaxel
n=13 Participants
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Number of Subjects Experiencing Dose-limiting Toxicity
|
1 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: A total of 6 subjects were excluded from the Efficacy Evaluable Set. Two (2) subjects did not have a baseline or post-baseline assessment for response; and 4 subjects were excluded due to "lack of investigational product(s) compliance", i.e., did not complete the first cycle of combination therapy (none of these subjects completed the Run-in period).
The anti-tumor effect based on the Response Evaluation Criteria in Solid Tumors (RECIST version1.1), as well as by the immune-related RECIST (irRECIST).
Outcome measures
| Measure |
Mogamulizumab + Docetaxel
n=7 Participants
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Overall Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: A total of 6 subjects were excluded from the Efficacy Evaluable Set. Two (2) subjects did not have a baseline or post-baseline assessment for response; and 4 subjects were excluded due to "lack of investigational product(s) compliance", i.e., did not complete the first cycle of combination therapy (none of these subjects completed the Run-in period).
The anti-tumor effect based on the Response Evaluation Criteria in Solid Tumors (RECIST version1.1), as well as by the immune-related RECIST (irRECIST).
Outcome measures
| Measure |
Mogamulizumab + Docetaxel
n=7 Participants
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Progression Free Survival by RECIST 1.1
|
1.87 months
Interval 0.76 to 4.47
|
SECONDARY outcome
Timeframe: One yearPopulation: A total of 6 subjects were excluded from the Efficacy Evaluable Set. Two (2) subjects did not have a baseline or post-baseline assessment for response; and 4subjects were excluded due to "lack of investigational product(s) compliance", i.e., did not complete the first cycle of combination therapy (none of these subjects completed the Run-in period).
The anti-tumor effect based on the Response Evaluation Criteria in Solid Tumors (RECIST version1.1), as well as by the immune-related RECIST (irRECIST).
Outcome measures
| Measure |
Mogamulizumab + Docetaxel
n=7 Participants
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Overall Survival
|
8.88 months
Interval 2.7 to 8.88
|
Adverse Events
Mogamulizumab + Docetaxel
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mogamulizumab + Docetaxel
n=13 participants at risk
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
15.4%
2/13
|
|
Infections and infestations
Sepsis
|
15.4%
2/13
|
|
Infections and infestations
Pneumonia Bacterial
|
7.7%
1/13
|
|
Infections and infestations
Septic shock
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13
|
|
Cardiac disorders
Acute myocardial infarction
|
7.7%
1/13
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13
|
|
Cardiac disorders
Cardiac failure congestive
|
7.7%
1/13
|
|
Vascular disorders
Hypotension
|
7.7%
1/13
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13
|
|
Renal and urinary disorders
Renal failure actue
|
7.7%
1/13
|
|
General disorders
Pyrexia
|
7.7%
1/13
|
Other adverse events
| Measure |
Mogamulizumab + Docetaxel
n=13 participants at risk
Mogamulizumab (1.0 mg/kg, iv) was administered as monotherapy once weekly for 4 weeks. Subsequently, subjects received mogamulizumab (1.0 mg/kg) in combination with docetaxel (75 mg/m2), as separate infusions, on Day 1 every 3-weeks for up to 6 cycles.
|
|---|---|
|
General disorders
Fatigue
|
46.2%
6/13
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.8%
4/13
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
30.8%
4/13
|
|
General disorders
Pyrexia
|
30.8%
4/13
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
3/13
|
|
Metabolism and nutrition disorders
Dehydration
|
23.1%
3/13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.1%
3/13
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13
|
|
Cardiac disorders
Cardiac failure congestive
|
15.4%
2/13
|
|
Cardiac disorders
Atrial fibrilliation
|
15.4%
2/13
|
|
Metabolism and nutrition disorders
Weight decreased
|
15.4%
2/13
|
|
Vascular disorders
Orthostatic hypotension
|
15.4%
2/13
|
|
Infections and infestations
Pneumonia
|
15.4%
2/13
|
|
Infections and infestations
Sepsis
|
15.4%
2/13
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.4%
2/13
|
|
Nervous system disorders
Paraesthesia
|
15.4%
2/13
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.4%
2/13
|
|
General disorders
Pain
|
15.4%
2/13
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.4%
2/13
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
2/13
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
7.7%
1/13
|
|
Infections and infestations
Thrush
|
7.7%
1/13
|
|
Psychiatric disorders
Mental status change
|
7.7%
1/13
|
|
Vascular disorders
Hypertension
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Palmer-plantar erythrodysaesthesia syndrome
|
7.7%
1/13
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13
|
|
General disorders
Asthenia
|
7.7%
1/13
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.7%
1/13
|
|
Eye disorders
Deafness
|
7.7%
1/13
|
|
Nervous system disorders
Balance disorder
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
7.7%
1/13
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
1/13
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
Laceration
|
7.7%
1/13
|
|
General disorders
Chest pain
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13
|
|
Vascular disorders
Hypotension
|
7.7%
1/13
|
|
Metabolism and nutrition disorders
Gout
|
7.7%
1/13
|
|
Gastrointestinal disorders
Abdominal hernia
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13
|
|
Investigations
Platelet count decreased
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.7%
1/13
|
|
General disorders
Peripheral swelling
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.7%
1/13
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
1/13
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13
|
|
Infections and infestations
Oral candidiasis
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13
|
|
General disorders
Chills
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.7%
1/13
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
1/13
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13
|
|
Nervous system disorders
Headache
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13
|
|
Psychiatric disorders
Disorientation
|
7.7%
1/13
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13
|
|
General disorders
Local swelling
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
7.7%
1/13
|
|
General disorders
Oedema peripheral
|
7.7%
1/13
|
Additional Information
Regional_Program Lead
Kyowa Kirin Pharmaceutical Development, Inc.
Phone: 1-609-919-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place