Trial Outcomes & Findings for Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC) (NCT NCT03646188)
NCT ID: NCT03646188
Last Updated: 2024-03-12
Results Overview
Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Placebo-containing MNA
Placebo
Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
|
25 µg Doxorubicin-containing MNA
D-MNA's containing 25 µg of doxorubicin hydrochloride
25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
|
50 µg Doxorubicin-containing MNA
D-MNA's containing 50 µg of doxorubicin hydrochloride
50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
|
100 µg Doxorubicin-containing MNA
D-MNA's containing 100 µg of doxorubicin hydrochloride
100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
|
200 µg Doxorubicin-containing MNA
D-MNA's containing 200 µg of doxorubicin hydrochloride
200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Escalation Trial to Evaluate Dose Limiting Toxicity/Maximum Tolerated Dose of Microneedle Arrays Containing Doxorubicin (D-MNA) in Basal Cell Carcinoma (BCC)
Baseline characteristics by cohort
| Measure |
Placebo-containing MNA
n=3 Participants
Placebo
Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
|
25 µg Doxorubicin-containing MNA
n=3 Participants
D-MNA's containing 25 µg of doxorubicin hydrochloride
25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
|
50 µg Doxorubicin-containing MNA
n=3 Participants
D-MNA's containing 50 µg of doxorubicin hydrochloride
50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
|
100 µg Doxorubicin-containing MNA
n=3 Participants
D-MNA's containing 100 µg of doxorubicin hydrochloride
100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
|
200 µg Doxorubicin-containing MNA
n=1 Participants
D-MNA's containing 200 µg of doxorubicin hydrochloride
200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
|
Total
n=13 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Age, Continuous
|
64.67 years
STANDARD_DEVIATION 31.72 • n=5 Participants
|
61.33 years
STANDARD_DEVIATION 8.505 • n=7 Participants
|
63.33 years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
79 years
STANDARD_DEVIATION 6.08 • n=4 Participants
|
67 years
STANDARD_DEVIATION NA • n=21 Participants
|
67.35 years
STANDARD_DEVIATION 14.48 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
13 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: All evaluable subjects
Dose Limiting Toxicity (DLT) in Trial Subjects Assessed by Local Skin Response Grading Scale, 0-4, 4 being the worst dermal response
Outcome measures
| Measure |
Placebo-containing MNA
n=3 Participants
Placebo
Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
|
25 µg Doxorubicin-containing MNA
n=3 Participants
D-MNA's containing 25 µg of doxorubicin hydrochloride
25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
|
50 µg Doxorubicin-containing MNA
n=3 Participants
D-MNA's containing 50 µg of doxorubicin hydrochloride
50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
|
100 µg Doxorubicin-containing MNA
n=3 Participants
D-MNA's containing 100 µg of doxorubicin hydrochloride
100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
|
200 µg Doxorubicin-containing MNA
n=1 Participants
D-MNA's containing 200 µg of doxorubicin hydrochloride
200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale
Participants
|
3 participants
|
3 participants
|
3 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Dose Limiting Toxicities as Assessed by Local Skin Response (LSR) Grading Scale
Participants with DLTs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: All evaluable subjects
Complete Response (CR), defined as histological confirmation by central reading of basal cell carcinoma excision in all study participants
Outcome measures
| Measure |
Placebo-containing MNA
n=3 Participants
Placebo
Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
|
25 µg Doxorubicin-containing MNA
n=3 Participants
D-MNA's containing 25 µg of doxorubicin hydrochloride
25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
|
50 µg Doxorubicin-containing MNA
n=3 Participants
D-MNA's containing 50 µg of doxorubicin hydrochloride
50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
|
100 µg Doxorubicin-containing MNA
n=3 Participants
D-MNA's containing 100 µg of doxorubicin hydrochloride
100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
|
200 µg Doxorubicin-containing MNA
n=1 Participants
D-MNA's containing 200 µg of doxorubicin hydrochloride
200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
|
|---|---|---|---|---|---|
|
Number of Participants With Complete Response (CR) of Eradicated Basal Cell Carcinoma as Measured by Histological Analysis
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Placebo-containing MNA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
25 µg Doxorubicin-containing MNA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
50 µg Doxorubicin-containing MNA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 µg Doxorubicin-containing MNA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 µg Doxorubicin-containing MNA
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo-containing MNA
n=3 participants at risk
Placebo
Placebo-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
|
25 µg Doxorubicin-containing MNA
n=3 participants at risk
D-MNA's containing 25 µg of doxorubicin hydrochloride
25 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
|
50 µg Doxorubicin-containing MNA
n=3 participants at risk
D-MNA's containing 50 µg of doxorubicin hydrochloride
50 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
|
100 µg Doxorubicin-containing MNA
n=3 participants at risk
D-MNA's containing 100 µg of doxorubicin hydrochloride
100 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
|
200 µg Doxorubicin-containing MNA
n=1 participants at risk
D-MNA's containing 200 µg of doxorubicin hydrochloride
200 µg doxorubicin-containing MNA: A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Application site pain
|
0.00%
0/3 • 50 days
Adverse events were recorded throughout the study and at early discontinuation. AEs and medical conditions were coded using the Medical Dictionary for Regulatory Activities (MedDRA) (Version 22.0). Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the initiation of treatment or any event already present that worsened in either intensity or frequency following exposure to treatment.
|
33.3%
1/3 • Number of events 1 • 50 days
Adverse events were recorded throughout the study and at early discontinuation. AEs and medical conditions were coded using the Medical Dictionary for Regulatory Activities (MedDRA) (Version 22.0). Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the initiation of treatment or any event already present that worsened in either intensity or frequency following exposure to treatment.
|
0.00%
0/3 • 50 days
Adverse events were recorded throughout the study and at early discontinuation. AEs and medical conditions were coded using the Medical Dictionary for Regulatory Activities (MedDRA) (Version 22.0). Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the initiation of treatment or any event already present that worsened in either intensity or frequency following exposure to treatment.
|
0.00%
0/3 • 50 days
Adverse events were recorded throughout the study and at early discontinuation. AEs and medical conditions were coded using the Medical Dictionary for Regulatory Activities (MedDRA) (Version 22.0). Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the initiation of treatment or any event already present that worsened in either intensity or frequency following exposure to treatment.
|
100.0%
1/1 • Number of events 1 • 50 days
Adverse events were recorded throughout the study and at early discontinuation. AEs and medical conditions were coded using the Medical Dictionary for Regulatory Activities (MedDRA) (Version 22.0). Treatment-emergent adverse events (TEAEs) were defined as any event not present prior to the initiation of treatment or any event already present that worsened in either intensity or frequency following exposure to treatment.
|
Additional Information
Dr. Huma Qamar, MD., Chief Scientific Officer
Medicus Pharma
Phone: 610- 540-7515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60