Trial Outcomes & Findings for Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer (NCT NCT00003656)
NCT ID: NCT00003656
Last Updated: 2022-03-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
After 8 weeks
Results posted on
2022-03-18
Participant Flow
Patients were recruited from between April 2002 and March 2005. Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
Participant milestones
| Measure |
Phase 1 Group
Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Phase 2 Group
Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Phase 1 Group
Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Phase 2 Group
Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phase 1 Group
n=12 Participants
Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Phase 2 Group
n=14 Participants
Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Median age
|
66.5 years
n=12 Participants
|
61.1 years
n=14 Participants
|
63.6 years
n=26 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants
|
4 Participants
n=14 Participants
|
9 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants
|
10 Participants
n=14 Participants
|
17 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Prior nephrectomy
Yes prior nephrectomy
|
12 Participants
n=12 Participants
|
12 Participants
n=14 Participants
|
24 Participants
n=26 Participants
|
|
Prior nephrectomy
No prior nephrectomy
|
0 Participants
n=12 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=26 Participants
|
|
Histology
Clear cell
|
7 Participants
n=12 Participants
|
9 Participants
n=14 Participants
|
16 Participants
n=26 Participants
|
|
Histology
Clear cell with sarcomatoid features
|
1 Participants
n=12 Participants
|
4 Participants
n=14 Participants
|
5 Participants
n=26 Participants
|
|
Histology
Papillary
|
1 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=26 Participants
|
|
Histology
Xp11
|
0 Participants
n=12 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=26 Participants
|
|
Histology
Unclassified
|
3 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
3 Participants
n=26 Participants
|
|
Number of patients with metastases at the time of diagnosis
|
6 Participants
n=12 Participants
|
8 Participants
n=14 Participants
|
14 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: After 8 weeksPopulation: Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
Outcome measures
| Measure |
Phase 1 Group
n=12 Participants
Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Phase 2 Group
n=14 Participants
Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
|---|---|---|
|
Best Response as Measured by CT, Bone Scans, and Clinical Progression
Complete Response
|
1 Participants
|
0 Participants
|
|
Best Response as Measured by CT, Bone Scans, and Clinical Progression
Minor Reponse
|
0 Participants
|
1 Participants
|
|
Best Response as Measured by CT, Bone Scans, and Clinical Progression
Partial Response
|
1 Participants
|
3 Participants
|
|
Best Response as Measured by CT, Bone Scans, and Clinical Progression
Stable Disease
|
5 Participants
|
4 Participants
|
|
Best Response as Measured by CT, Bone Scans, and Clinical Progression
Disease Progression
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: In 30 days after the last dose, an average of 1 year.Population: Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
Outcome measures
| Measure |
Phase 1 Group
n=12 Participants
Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Phase 2 Group
n=14 Participants
Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
|---|---|---|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Fatigue : Grade 1
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Fatigue : Grade 2
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Fatigue : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Fatigue : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Skin : Grade 1
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Skin : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Skin : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Skin : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Xeroderma : Grade 1
|
11 Participants
|
5 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Xeroderma : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Xeroderma : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Xeroderma : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Constipation : Grade 1
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Constipation : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Constipation : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Constipation : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Cough : Grade 1
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Cough : Grade 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Cough : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Cough : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Anemia : Grade 1
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Anemia : Grade 2
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Infusion reaction : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Pulmonary : Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Pulmonary : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Pulmonary : Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Pulmonary : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Nasal congestion : Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Nasal congestion : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Nasal congestion : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Anemia : Grade 3
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Anemia : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Anorexia : Grade 1
|
9 Participants
|
6 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Anorexia : Grade 2
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Anorexia : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Anorexia : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Neurologic : Grade 1
|
8 Participants
|
9 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Neurologic : Grade 2
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Neurologic : Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Neurologic : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Diarrhea : Grade 1
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Diarrhea : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Diarrhea : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Diarrhea : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Nausea/vomiting : Grade 1
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Nausea/vomiting : Grade 2
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Nausea/vomiting : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Nausea/vomiting : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Altered mood : Grade 1
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Altered mood : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Altered mood : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Altered mood : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Leukopenia : Grade 1
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Leukopenia : Grade 2
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Leukopenia : Grade 3
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Leukopenia : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Fever : Grade 1
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Fever : Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Fever : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Fever : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Renal : Grade 1
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Renal : Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Renal : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Renal : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Liver : Grade 1
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Liver : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Liver : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Liver : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Thrombocytopenia : Grade 1
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Thrombocytopenia : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Thrombocytopenia : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Thrombocytopenia : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Infusion reaction : Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Infusion reaction : Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Infusion reaction : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Nasal congestion : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Hypotension : Grade 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Hypotension : Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Hypotension : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Hypotension : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Cholesterol/TG : Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Cholesterol/TG : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Cholesterol/TG : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Cholesterol/TG : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Bone pain : Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Bone pain : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Bone pain : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Bone pain : Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Other pain : Grade 1
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Other pain : Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Other pain : Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose
Other pain : Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and 5th weekPopulation: Phase 1 portion at the RP2D of 90 mg/m2. 6 patients (12 in phase 1 w 6 at 75 mg/m2 and 6 at 90 mg/m2). This was not completed on the other 14 in phase 2 portion.
Outcome measures
| Measure |
Phase 1 Group
n=6 Participants
Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Phase 2 Group
Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
|---|---|---|
|
Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At 6 months and 12 monthsPopulation: Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
Outcome measures
| Measure |
Phase 1 Group
n=12 Participants
Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Phase 2 Group
n=14 Participants
Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
|---|---|---|
|
Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response
6 month
|
5 Participants
|
7 Participants
|
|
Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response
12 month
|
4 Participants
|
3 Participants
|
Adverse Events
Phase 1 Group
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase 2 Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Group
n=12 participants at risk
Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Phase 2 Group
n=14 participants at risk
Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
|---|---|---|
|
Investigations
Leukopenia
|
8.3%
1/12 • Number of events 1
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
0.00%
0/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
Other adverse events
| Measure |
Phase 1 Group
n=12 participants at risk
Weekly ATRA-IV (with three dose levels: 60, 75, and 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
Phase 2 Group
n=14 participants at risk
Weekly ATRA-IV (dosage of 90 mg/m2) with recombinant interferon alfa recombinant interferon alfa tretinoin liposome
|
|---|---|---|
|
General disorders
Fatigue - Grade 2
|
41.7%
5/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
28.6%
4/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
41.7%
5/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
28.6%
4/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
33.3%
4/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
0.00%
0/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 2
|
16.7%
2/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
0.00%
0/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Blood and lymphatic system disorders
Anemia - Grade 1
|
25.0%
3/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
14.3%
2/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Blood and lymphatic system disorders
Anemia - Grade 2
|
8.3%
1/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
35.7%
5/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Blood and lymphatic system disorders
Anemia - Grade 3
|
16.7%
2/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
0.00%
0/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Metabolism and nutrition disorders
Anorexia - Grade 1
|
75.0%
9/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
42.9%
6/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Metabolism and nutrition disorders
Anorexia - Grade 2
|
16.7%
2/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
14.3%
2/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Skin and subcutaneous tissue disorders
Skin - Grade 1
|
8.3%
1/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
21.4%
3/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Skin and subcutaneous tissue disorders
Xeroderma - Grade 1
|
91.7%
11/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
35.7%
5/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Nervous system disorders
Neurologic - Grade 1
|
66.7%
8/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
64.3%
9/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Nervous system disorders
Neurologic - Grade 3
|
8.3%
1/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
0.00%
0/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
41.7%
5/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
28.6%
4/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Gastrointestinal disorders
Nausea/Vomiting - Grade 1
|
16.7%
2/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
42.9%
6/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Gastrointestinal disorders
Nausea/Vomiting - Grade 2
|
16.7%
2/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Psychiatric disorders
Altered Mood - Grade 1
|
66.7%
8/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
28.6%
4/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 1
|
16.7%
2/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
14.3%
2/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
General disorders
Fatigue - Grade 1
|
58.3%
7/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
57.1%
8/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 2
|
16.7%
2/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 3
|
16.7%
2/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
0.00%
0/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Immune system disorders
Fever - Grade 1
|
33.3%
4/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
35.7%
5/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Immune system disorders
Fever - Grade 2
|
8.3%
1/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
0.00%
0/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Renal and urinary disorders
Renal - Grade 1
|
8.3%
1/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
21.4%
3/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Renal and urinary disorders
Renal - Grade 2
|
8.3%
1/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
0.00%
0/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Hepatobiliary disorders
Liver - Grade 1
|
8.3%
1/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
14.3%
2/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 1
|
16.7%
2/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
21.4%
3/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
General disorders
Infusion Reaction - Grade 2
|
0.00%
0/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Grade 1
|
0.00%
0/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Cardiac disorders
Hypotension - Grade 2
|
0.00%
0/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Blood and lymphatic system disorders
Cholesterol/TG - Grade 1
|
0.00%
0/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain - Grade 1
|
0.00%
0/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
General disorders
Other Pain - Grade 1
|
0.00%
0/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
35.7%
5/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Nervous system disorders
Neurologic - Grade 2
|
25.0%
3/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Grade 3
|
0.00%
0/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion - Grade 1
|
0.00%
0/12
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
7.1%
1/14
Data are only available as a combined Arm/Group based on information contained in the study publication. No additional study data is available despite exhausting all efforts to locate the data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place