Trial Outcomes & Findings for Randomized, Multi-center, Open-label, Study of PR104 Versus PR104/Docetaxel in Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00862134)
NCT ID: NCT00862134
Last Updated: 2013-01-10
Results Overview
Defined as the number of subjects with complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Participants were followed for the duration on study, an average of 4 months
Results posted on
2013-01-10
Participant Flow
Participant milestones
| Measure |
Docetaxel
75 mg/m\^2 docetaxel, IV, every 21 days
|
PR104 + Docetaxel
Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic Granulocyte Colony-stimulating Factor (G-CSF).
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
23
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
Docetaxel
75 mg/m\^2 docetaxel, IV, every 21 days
|
PR104 + Docetaxel
Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic Granulocyte Colony-stimulating Factor (G-CSF).
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Sponsor terminated study
|
5
|
7
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrew prior to dosing
|
2
|
0
|
Baseline Characteristics
Randomized, Multi-center, Open-label, Study of PR104 Versus PR104/Docetaxel in Non-Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Docetaxel
n=19 Participants
75 mg/m\^2 docetaxel, IV, every 21 days
|
PR104 + Docetaxel
n=23 Participants
Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic G-CSF.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age Continuous
|
61 years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
64 years
STANDARD_DEVIATION 7.58 • n=7 Participants
|
63 years
STANDARD_DEVIATION 7.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration on study, an average of 4 monthsDefined as the number of subjects with complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Outcome measures
| Measure |
Docetaxel
n=17 Participants
75 mg/m\^2 docetaxel, IV, every 21 days
|
PR104 + Docetaxel
n=21 Participants
Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic G-CSF.
|
|---|---|---|
|
Number of Participants That Achieved a Response (Complete or Partial) After Receiving PR104/Docetaxel Versus Docetaxel Alone
Complete Response (CR)
|
0 participants
|
0 participants
|
|
Number of Participants That Achieved a Response (Complete or Partial) After Receiving PR104/Docetaxel Versus Docetaxel Alone
Partial Response (PR)
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 30 days following last administration of study treatmentThe number of participants with at least one Serious Adverse Event was measured.
Outcome measures
| Measure |
Docetaxel
n=17 Participants
75 mg/m\^2 docetaxel, IV, every 21 days
|
PR104 + Docetaxel
n=23 Participants
Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic G-CSF.
|
|---|---|---|
|
Safety and Tolerability: Serious Adverse Events
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Within 1 year of enrollmentAKR1C3 was evaluated on a semi-quantitative scale, and the percentage of cells staining at each of the following four levels was recorded: 0 (unstained), 1+ (weak staining), 2+ (moderate staining) and 3+ (strong staining). Patients with a strong staining score (3+) were considered to be AKR1C3 positive
Outcome measures
| Measure |
Docetaxel
n=11 Participants
75 mg/m\^2 docetaxel, IV, every 21 days
|
PR104 + Docetaxel
n=12 Participants
Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic G-CSF.
|
|---|---|---|
|
Positive Aldo-keto Reductase 1C3 (AKR1C3) Expression in Participating Patients
|
5 participants
|
8 participants
|
Adverse Events
Docetaxel
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
PR104 + Docetaxel
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel
n=17 participants at risk
75 mg/m\^2 docetaxel, IV, every 21 days
|
PR104 + Docetaxel
n=23 participants at risk
Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic G-CSF.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
5.9%
1/17
|
4.3%
1/23
|
|
Infections and infestations
Sepsis
|
5.9%
1/17
|
0.00%
0/23
|
|
General disorders
Chest Pain (atypical)
|
11.8%
2/17
|
0.00%
0/23
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Ileus, GI
|
0.00%
0/17
|
0.00%
0/23
|
|
Infections and infestations
Acute RLL Pneumonia
|
11.8%
2/17
|
0.00%
0/23
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
0.00%
0/17
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17
|
8.7%
2/23
|
|
Gastrointestinal disorders
Gastroenteritis
|
5.9%
1/17
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress
|
5.9%
1/17
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Spinal Cord Compression
|
0.00%
0/17
|
4.3%
1/23
|
Other adverse events
| Measure |
Docetaxel
n=17 participants at risk
75 mg/m\^2 docetaxel, IV, every 21 days
|
PR104 + Docetaxel
n=23 participants at risk
Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic G-CSF.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
58.8%
10/17
|
60.9%
14/23
|
|
Blood and lymphatic system disorders
Neutropenia
|
58.8%
10/17
|
60.9%
14/23
|
|
Blood and lymphatic system disorders
Leukopenia
|
58.8%
10/17
|
56.5%
13/23
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/17
|
30.4%
7/23
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
47.1%
8/17
|
30.4%
7/23
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
35.3%
6/17
|
17.4%
4/23
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17
|
8.7%
2/23
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/17
|
13.0%
3/23
|
|
General disorders
Fatigue
|
52.9%
9/17
|
34.8%
8/23
|
|
General disorders
Non-cardiac chest pain
|
11.8%
2/17
|
8.7%
2/23
|
|
General disorders
Asthenia
|
5.9%
1/17
|
0.00%
0/23
|
|
General disorders
Irritability
|
5.9%
1/17
|
0.00%
0/23
|
|
General disorders
Oedema
|
5.9%
1/17
|
0.00%
0/23
|
|
General disorders
Oedema peripheral
|
5.9%
1/17
|
0.00%
0/23
|
|
General disorders
Diarrhoea
|
5.9%
1/17
|
8.7%
2/23
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
2/17
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.8%
2/17
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17
|
8.7%
2/23
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
1/17
|
4.3%
1/23
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Gastric ileus
|
5.9%
1/17
|
0.00%
0/23
|
|
Gastrointestinal disorders
Glossodynia
|
5.9%
1/17
|
0.00%
0/23
|
|
Infections and infestations
Pneumonia
|
29.4%
5/17
|
0.00%
0/23
|
|
Infections and infestations
Candidiasis
|
5.9%
1/17
|
4.3%
1/23
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17
|
0.00%
0/23
|
|
Infections and infestations
Fungal infection
|
5.9%
1/17
|
0.00%
0/23
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17
|
0.00%
0/23
|
|
Infections and infestations
Staphylococcal infection
|
5.9%
1/17
|
0.00%
0/23
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17
|
0.00%
0/23
|
|
Infections and infestations
Viral infection
|
5.9%
1/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
2/17
|
17.4%
4/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17
|
8.7%
2/23
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
11.8%
2/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.9%
1/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.9%
1/17
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.9%
1/17
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17
|
8.7%
2/23
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.6%
3/17
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17
|
4.3%
1/23
|
|
Nervous system disorders
Headache
|
17.6%
3/17
|
0.00%
0/23
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.8%
2/17
|
8.7%
2/23
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17
|
4.3%
1/23
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
5.9%
1/17
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.9%
1/17
|
0.00%
0/23
|
|
Psychiatric disorders
Insomnia
|
17.6%
3/17
|
4.3%
1/23
|
|
Psychiatric disorders
Delirium
|
5.9%
1/17
|
0.00%
0/23
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17
|
4.3%
1/23
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17
|
0.00%
0/23
|
|
Investigations
Electrocardiogram abnormal
|
5.9%
1/17
|
0.00%
0/23
|
|
Investigations
Hepatitis C virus
|
5.9%
1/17
|
0.00%
0/23
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
5.9%
1/17
|
0.00%
0/23
|
|
Cardiac disorders
Acute myocardial infarction
|
5.9%
1/17
|
0.00%
0/23
|
|
Cardiac disorders
Angina pectoris
|
5.9%
1/17
|
0.00%
0/23
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.9%
1/17
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
5.9%
1/17
|
0.00%
0/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Single site data may be published/presented prior to the publication of multi-center data from overall study if agreed to by the sponsor in writing, or 12 months have elapsed following termination or completion of the study, whichever comes first.
- Publication restrictions are in place
Restriction type: OTHER