Trial Outcomes & Findings for Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers (NCT NCT00319748)
NCT ID: NCT00319748
Last Updated: 2019-08-26
Results Overview
Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.
COMPLETED
PHASE2
15 participants
after 12 weeks (24 doses of 852A)
2019-08-26
Participant Flow
15 patients were originally consented to enter the study; however 1 patient died before participating in study and 1 patient made the decision to withdraw before being treated.
Participant milestones
| Measure |
Patients Treated With 852A
Patients that received at least one dose of study treatment with 852A (0.6 mg/m\^2 to 1.2 mg/m\^2 dose, 2 times/week for 12 weeks).
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers
Baseline characteristics by cohort
| Measure |
Patients Treated With 852A Study Drug
n=13 Participants
Patients that received at least one dose of study treatment with 852A (0.6 mg/m\^2 to 1.2 mg/m\^2 dose, 2 times/week for 12 weeks).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
52 years
FULL_RANGE 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 12 weeks (24 doses of 852A)Population: Includes only patients that received all 24 doses of 852A.
Assessment of anti-tumor activity of 852A using Response Evaluation Criteria in Solid Tumors (RECIST) criteria to evaluate tumor response after 24 doses. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR) = at least 30% decrease in sum of longest diameter of target lesions, Progressive Disease (PD) = at least 25% increase in sum of longest diameter of target lesions, Stable Disease = neither PR or PD.
Outcome measures
| Measure |
Patients With Ovarian Cancer
n=3 Participants
Participants with ovarian cancer who received all 24 doses of 852A.
|
|---|---|
|
Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
Complete Response
|
0 Participants
|
|
Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
Partial Response
|
0 Participants
|
|
Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
Stable Disease
|
1 Participants
|
|
Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.
Progressive Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 6 hours after Dose 1Population: One patient did not have value reported at 6 hours after treatment, so cannot be included.
Measures the difference of IL1ra (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Outcome measures
| Measure |
Patients With Ovarian Cancer
n=12 Participants
Participants with ovarian cancer who received all 24 doses of 852A.
|
|---|---|
|
Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra)
|
6265.10 pg/mL
Interval -1105.01 to 13635.21
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 6 Hours Post-DosePopulation: One patient did not have a value reported at 6 hours after treatment so cannot be included in analysis.
Measures differences in IP-10 (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Outcome measures
| Measure |
Patients With Ovarian Cancer
n=12 Participants
Participants with ovarian cancer who received all 24 doses of 852A.
|
|---|---|
|
Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10)
|
1685.96 pg/mL
Interval 546.82 to 2825.1
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 6 Hours Post-DosePopulation: Only 5 patients had a value reported at 6 hours after treatment.
Measures difference in MIP-1a (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Outcome measures
| Measure |
Patients With Ovarian Cancer
n=5 Participants
Participants with ovarian cancer who received all 24 doses of 852A.
|
|---|---|
|
Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a)
|
95.72 pg/mL
Interval -50.77 to 242.2
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 6 Hours Post-DosePopulation: Two patients did not have recorded values at 6 hours after treatment so cannot be included in analysis.
Measures difference in Macrophage Inflammatory Protein-1 Beta (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Outcome measures
| Measure |
Patients With Ovarian Cancer
n=11 Participants
Participants with ovarian cancer who received all 24 doses of 852A.
|
|---|---|
|
Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b)
|
141.04 pg/mL
Interval -95.72 to 377.84
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 6 Hours Post-DosePopulation: One patient did not have recorded value at 6 hours after treatment and cannot be included in analysis.
Measures difference in Soluble CD40 ligand (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Outcome measures
| Measure |
Patients With Ovarian Cancer
n=12 Participants
Participants with ovarian cancer who received all 24 doses of 852A.
|
|---|---|
|
Mean Difference Values for Soluble CD40 Ligand (sCD40L)
|
-1061.96 pg/mL
Interval -5110.99 to 29878.08
|
SECONDARY outcome
Timeframe: Prior to Dose 1 and 6 Hours Post-DosePopulation: Only 9 patients had recorded values at 6 hours after treatment and were included in analysis.
Measures difference in Tumor necrosis factor-alpha (cytokine) values as a means of immune activation pre-treatment and 6 hours post-treatment in patients that received at least one dose of study treatment with 852A.
Outcome measures
| Measure |
Patients With Ovarian Cancer
n=9 Participants
Participants with ovarian cancer who received all 24 doses of 852A.
|
|---|---|
|
Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a)
|
8.26 pg/mL
Interval -10.1 to 26.63
|
Adverse Events
Patients Treated With 852A Study Drug
Serious adverse events
| Measure |
Patients Treated With 852A Study Drug
n=13 participants at risk
Patients that received at least one dose of study treatment with 852A (0.6 mg/m\^2 to 1.2 mg/m\^2 dose, 2 times/week for 12 weeks).
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Cardiac disorders
Acute idiopathic cardiomyopathy
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Gastrointestinal disorders
Anorexia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Cardiac disorders
Cardiac left ventricular function
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Cardiac disorders
Cardiac troponin levels increased
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
General disorders
Death due to Progressive Disease
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Gastrointestinal disorders
Dehydration
|
23.1%
3/13 • Number of events 3 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Blood and lymphatic system disorders
Infection/Febrile Neutropenia
|
23.1%
3/13 • Number of events 3 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
General disorders
Pain
|
23.1%
3/13 • Number of events 5 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Renal and urinary disorders
Renal failure
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Renal and urinary disorders
Renal, other
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from beginning of study through 12 weeks (24 doses of study drug).
Safety (toxicity) is one of the objectives of this study. Only serious adverse events were reported and collected as part of this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Melissa Geller, M.D.
Masonic Cancer Center, University of Minnesota
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place