Trial Outcomes & Findings for Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer (NCT NCT00406276)
NCT ID: NCT00406276
Last Updated: 2013-08-23
Results Overview
Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
6 weeks
Results posted on
2013-08-23
Participant Flow
Participant milestones
| Measure |
RAD001+Docetaxel
Docetaxel 60 mg/m\^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/II Trial of RAD001 Plus Docetaxel in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
RAD001+Docetaxel
n=28 Participants
Docetaxel 60 mg/m\^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 24 patients received at least 2 cycles of therapy and underwent imaging studies to assess response.
Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD), taking as reference the smallest sum Longest diameter(LD) since treatment started.
Outcome measures
| Measure |
Docetaxel/RAD001
n=24 Participants
Docetaxel 60 mg/m\^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
|
|---|---|
|
Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.
Partial response
|
2 participants
|
|
Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.
Stable disease
|
15 participants
|
|
Number of Subjects Showing Partial Response and Stable Disease With the Combination of RAD001 and Docetaxel.
Disease Progression
|
7 participants
|
PRIMARY outcome
Timeframe: 6 monthsPeriod from study entry until disease progression, death, or last date of contact. Progressive Disease: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Docetaxel/RAD001
n=22 Participants
Docetaxel 60 mg/m\^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
|
|---|---|
|
Time to Progression:Time Period (in Months) From Study Entry Until Disease Progression, Death, or Last Date of Contact.
|
4.42 Months
Interval 1.1 to 6.0
|
Adverse Events
RAD001+Docetaxel
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD001+Docetaxel
n=28 participants at risk
Docetaxel 60 mg/m\^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
2/28
|
|
Gastrointestinal disorders
small bowel resection
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.6%
1/28
|
|
General disorders
death
|
3.6%
1/28
|
Other adverse events
| Measure |
RAD001+Docetaxel
n=28 participants at risk
Docetaxel 60 mg/m\^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
4/28
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
4/28
|
|
Blood and lymphatic system disorders
Low albumin
|
10.7%
3/28
|
|
General disorders
Back pain
|
7.1%
2/28
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28
|
|
Gastrointestinal disorders
Fatigue
|
39.3%
11/28
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
7/28
|
|
Blood and lymphatic system disorders
Cholesterol
|
7.1%
2/28
|
|
General disorders
Leg pain
|
7.1%
2/28
|
|
Endocrine disorders
Alopecia
|
3.6%
1/28
|
|
Gastrointestinal disorders
Anorexia
|
14.3%
4/28
|
|
Cardiac disorders
Hypertension
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.7%
3/28
|
|
Gastrointestinal disorders
mucositis
|
7.1%
2/28
|
|
Blood and lymphatic system disorders
Triglycerides
|
7.1%
2/28
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
Hypocalcemia
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Low phosphorous
|
7.1%
2/28
|
|
Musculoskeletal and connective tissue disorders
Nail changes
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
39.3%
11/28
|
|
Blood and lymphatic system disorders
Low creatinine
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
3.6%
1/28
|
|
General disorders
Weightloss
|
3.6%
1/28
|
|
General disorders
pain
|
10.7%
3/28
|
|
Nervous system disorders
peripheral neuropathy
|
3.6%
1/28
|
|
Infections and infestations
Infection
|
3.6%
1/28
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
dyspnea
|
14.3%
4/28
|
|
Nervous system disorders
Neuropathy Sensory
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
3.6%
1/28
|
|
Gastrointestinal disorders
Stomatitis
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
elevated ALK Phosphorous
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Low sodium
|
3.6%
1/28
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28
|
|
General disorders
dizziness
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
3.6%
1/28
|
|
General disorders
headache
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
neutropenia
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Thrombosis
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Low white blood cells count
|
3.6%
1/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place