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Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer

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ClinicalTrials.gov Identifier: NCT02009332
Recruitment Status : Completed
First Posted : December 12, 2013
Results First Posted : June 8, 2021
Last Update Posted : June 8, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Aadi, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-muscle Invasive Bladder Cancer (NMIBC)
Interventions Drug: ABI-009
Drug: Gemcitabine
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase 1: ABI-009 100 mg/Week Phase 1: ABI-009 200 mg/Week Phase 1: ABI-009 100 mg 2×/Week Phase 1: ABI-009 300 mg/Week Phase 1: ABI-009 400 mg/Week Phase 2: ABI-009 200 mg/Week + Gemcitabine 2000 mg/Week
Hide Arm/Group Description Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks
Period Title: Phase 1: Dose Level 1 (Weeks 1-10)
Started 3 0 0 0 0 0
Completed 3 [1] 0 0 0 0 0
Not Completed 0 0 0 0 0 0
[1]
Cohort 1 completed 6-week treatment.
Period Title: Phase 1: Dose Level 2/2b (Wks 11-29)
Started 0 4 1 0 0 0
Completed 0 3 [1] 1 [2] 0 0 0
Not Completed 0 1 0 0 0 0
Reason Not Completed
Physician Decision             0             1             0             0             0             0
[1]
Cohort 2 completed 6-week treatment.
[2]
Cohort 2b stopped due to lack of enrollment.
Period Title: Phase 1: Dose Level 3 (Weeks 30-47)
Started 0 0 0 3 0 0
Completed 0 0 0 3 [1] 0 0
Not Completed 0 0 0 0 0 0
[1]
Cohort 3 completed 6-week treatment.
Period Title: Phase 1: Dose Level 4 (Weeks 48-77)
Started 0 0 0 0 4 0
Completed 0 0 0 0 3 [1] 0
Not Completed 0 0 0 0 1 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1             0
[1]
Cohort 4 completed 6-week treatment.
Period Title: Phase 2 (Weeks 206-252)
Started 0 0 0 0 0 6
Completed 0 0 0 0 0 5 [1]
Not Completed 0 0 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             1
[1]
Phase 2 stopped due to lack of efficacy.
Arm/Group Title Phase 1: ABI-009 100 mg/Week Phase 1: ABI-009 200 mg/Week Phase 1: ABI-009 100 mg 2x/Week Phase 1: ABI-009 300 mg/Week Phase 1: ABI-009 400 mg/Week Phase 2, Efficacy Total
Hide Arm/Group Description Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 3 4 1 3 4 6 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 6 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
3
  75.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  14.3%
>=65 years
3
 100.0%
1
  25.0%
1
 100.0%
3
 100.0%
4
 100.0%
6
 100.0%
18
  85.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 6 participants 21 participants
Female
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
2
   9.5%
Male
2
  66.7%
4
 100.0%
1
 100.0%
3
 100.0%
4
 100.0%
5
  83.3%
19
  90.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 6 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
4
 100.0%
1
 100.0%
3
 100.0%
4
 100.0%
6
 100.0%
21
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 4 participants 1 participants 3 participants 4 participants 6 participants 21 participants
3 4 1 3 4 6 21
1.Primary Outcome
Title Phase 1: Dose Limiting Toxicities (DLT) Following Intravesical Administration of ABI-009
Hide Description The primary endpoint of the Phase 1 study is DLT following intravesical administration of ABI-009 in patients with BCG refractory or recurrent nonmuscle-invasive transitional cell carcinoma (TCC) of the bladder to identify maximum deliverable dose (MDD). Systemic DLT will be defined as any grade systemic toxicity using the NCI CTCAE version 4.0. Local dose limiting toxicity was defined as grade 3 or 4 bladder toxicity (hematuria, dysuria, urinary retention, urinary frequency/urgency, or bladder spasms) using the NCI CTCAE version 4.0.
Time Frame Duration of treatment (6 weeks) plus 30 days follow up (up to 2.5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All Phase 1 patients who received at least 1 treatment.
Arm/Group Title Phase 1: ABI-009 100 mg/Week Phase 1: ABI-009 200 mg/Week Phase 1: ABI-009 100 mg 2×/Week Phase 1: ABI-009 300 mg/Week Phase 1: ABI-009 400 mg/Week
Hide Arm/Group Description:

Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Overall Number of Participants Analyzed 3 4 1 3 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase 1: ABI-009 100 mg/Week, Phase 1: ABI-009 200 mg/Week, Phase 1: ABI-009 100 mg 2×/Week, Phase 1: ABI-009 300 mg/Week, Phase 1: ABI-009 400 mg/Week
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter maximum deliverable dose (MDD)
Estimated Value 400
Estimation Comments Maximum deliverable dose (MDD) was not reached in the Phase 1 study as no DLTs were observed in any of the dose groups up to ABI-009 400 mg/week.
2.Primary Outcome
Title Phase 2: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 and Gemcitabine
Hide Description The primary objective of the Phase 2 study is to evaluate the utility (potential for clinical efficacy) of ABI-009 in combination with gemcitabine in the treatment of BCG refractory or recurrent nonmuscle-invasive TCC of the bladder. Response rate will be measured and documented at the 6-week post-treatment assessment, including cystoscopy with biopsy. A complete response is defined as a cancer-negative biopsy at the 6-week post-treatment cystoscopy. No response will be defined as positive cystoscopic biopsy.
Time Frame End of Study [EOS, 3 months]
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all patients who have completed the planned 6 treatment cycles and have 6 week follow up cystoscopy data available
Arm/Group Title Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week
Hide Arm/Group Description:
ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  20.0%
3.Secondary Outcome
Title Phase 1: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009
Hide Description Response rate will be measured and documented at the 6-week post-treatment assessment, including cystoscopy with biopsy. A complete response is defined as a cancer-negative biopsy at the 6-week post-treatment cystoscopy. No response will be defined as positive cystoscopic biopsy.
Time Frame End of Study [EOS, 3 months]
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes all patients who have completed the planned 6 treatment cycles and have 6 week follow up cystoscopy data available.
Arm/Group Title Phase 1: ABI-009 100 mg/Week Phase 1: ABI-009 200 mg/Week Phase 1: ABI-009 100 mg 2×/Week Phase 1: ABI-009 300 mg/Week Phase 1: ABI-009 400 mg/Week
Hide Arm/Group Description:

Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks

ABI-009: ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.

Overall Number of Participants Analyzed 3 3 1 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
  33.3%
Time Frame From the signing of the informed consent through the 6-week induction treatment period and the 30-day follow-up period (up to 2.5 months). An additional 4 months for patients who received 3 additional monthly maintenance treatments (up to 6.5 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1: ABI-009 100 mg/Week Phase 1: ABI-009 200 mg/Week Phase 1: ABI-009 100 mg 2×/Week Phase 1: ABI-009 300 mg/Week Phase 1: ABI-009 400 mg/Week Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week
Hide Arm/Group Description Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks
All-Cause Mortality
Phase 1: ABI-009 100 mg/Week Phase 1: ABI-009 200 mg/Week Phase 1: ABI-009 100 mg 2×/Week Phase 1: ABI-009 300 mg/Week Phase 1: ABI-009 400 mg/Week Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/4 (0.00%)      0/1 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Phase 1: ABI-009 100 mg/Week Phase 1: ABI-009 200 mg/Week Phase 1: ABI-009 100 mg 2×/Week Phase 1: ABI-009 300 mg/Week Phase 1: ABI-009 400 mg/Week Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/4 (0.00%)      0/1 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase 1: ABI-009 100 mg/Week Phase 1: ABI-009 200 mg/Week Phase 1: ABI-009 100 mg 2×/Week Phase 1: ABI-009 300 mg/Week Phase 1: ABI-009 400 mg/Week Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      1/4 (25.00%)      1/1 (100.00%)      3/3 (100.00%)      3/4 (75.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders             
Anemia  1  1/3 (33.33%)  1 0/4 (0.00%)  0 1/1 (100.00%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0 1/6 (16.67%)  2
Thrombocytopenia  1  1/3 (33.33%)  1 0/4 (0.00%)  0 1/1 (100.00%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Decreased absolute neutrophil  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Decreased white blood cell  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Fever  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  2
Cardiac disorders             
Worsening of congestive heart failure  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders             
Nausea  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/6 (33.33%)  2
General disorders             
Malaise  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Hepatobiliary disorders             
Elevated bilirubin  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders             
Hyperglycemia  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Hyponatremia  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  2
Musculoskeletal and connective tissue disorders             
Worsening of edema of extremities  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  3
Nervous system disorders             
Headache  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders             
Hematuria  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/1 (100.00%)  1 2/3 (66.67%)  2 1/4 (25.00%)  1 0/6 (0.00%)  0
Urinary tract infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/1 (100.00%)  1 1/3 (33.33%)  1 1/4 (25.00%)  1 2/6 (33.33%)  2
Increased frequency and urgency of urination  1  1/3 (33.33%)  3 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  3 1/6 (16.67%)  1
Abnormal urine analysis  1  0/3 (0.00%)  0 1/4 (25.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Dysuria  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  2 0/6 (0.00%)  0
Incontinence  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Kidney stone  1  0/3 (0.00%)  0 0/4 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Elevated creatinine  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Bladder spasm  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 5/6 (83.33%)  21
Urinary tract pain  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 3/6 (50.00%)  9
Worsening of chronic kidney disease  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Acute kidney injury  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Reproductive system and breast disorders             
Penis Lesion/rash  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Prostatitis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 1/6 (16.67%)  1
Pleural effusion  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  2
Upper respiratory tract infection  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Pulmonary edema  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1
Skin and subcutaneous tissue disorders             
Inguinal and thigh pruritus  1  1/3 (33.33%)  1 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0
Mucositis  1  0/3 (0.00%)  0 0/4 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  3
1
Term from vocabulary, NCI CTCAE v4.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Berta Grigorian
Organization: Aadi Bioscience
Phone: 818-416-8378
EMail: bgrigorian@aadibio.com
Layout table for additonal information
Responsible Party: Aadi, LLC
ClinicalTrials.gov Identifier: NCT02009332    
Other Study ID Numbers: BC001
1R42CA171552-01 ( U.S. NIH Grant/Contract )
First Submitted: December 8, 2013
First Posted: December 12, 2013
Results First Submitted: March 8, 2021
Results First Posted: June 8, 2021
Last Update Posted: June 8, 2021