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A Study of ENMD-2076 in Ovarian Clear Cell Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01914510
Recruitment Status : Completed
First Posted : August 2, 2013
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Clear Cell Carcinoma
Intervention Drug: ENMD-2076
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ENMD-2076
Hide Arm/Group Description ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday, for the 28-day cycles. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients continue treatment until disease progression or unacceptable toxicity. Two dose reductions, 225mg and 150mg, are allowed (200mg and 150mg for patients with a body surface area under 1.65m2) and interruptions of therapy up to two weeks are permitted for recovery from toxicity or intercurrent illness.
Period Title: Overall Study
Started 40
Completed 38
Not Completed 2
Arm/Group Title ENMD-2076
Hide Arm/Group Description ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday for 28 day cycles. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday for 28 day cycles. Patients can continue on therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface under 1.65m2) are permitted, with up to two weeks of therapy interruptions permitted for recovery from toxicity or intercurrent illness.
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
Of the 40 participants accrued onto trial, 38 were evaluable. Two participants did not complete therapy, and were deemed unevaluable
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 38 participants
54
(39 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
38
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
American Indian or Alaska Native
0
   0.0%
Asian
11
  28.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
26
  68.4%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.6%
Prior Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
1 previous therapy
22
  57.9%
2 previous therapies
12
  31.6%
3 previous therapies
4
  10.5%
1.Primary Outcome
Title Six Month Progression Free Survival Rate
Hide Description Progression Free Survival (PFS) is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause or last follow up. PFS will be censored for patients who are alive and free of progression at time of last follow-up.
Time Frame Response will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. Progression free survival is the time from the first day of treatment to the first observation of disease progression or Death/last F/U.
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 40 participants enrolled, 38 were deemed eligible for evaluation. Two patients did not complete one cycle of therapy and were considered not evaluable.
Arm/Group Title ENMD-2076
Hide Arm/Group Description:
ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue on therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of therapy interruption for recovery from toxicity or intercurrent illness.
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
8
  21.1%
2.Primary Outcome
Title Complete or Partial Response Rate
Hide Description Percentage of patients with complete or partial response as per RECIST 1.1 criteria.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 40 participants enrolled onto trial, 38 were deemed eligible for evaluation. 2 patients did not complete a cycle of therapy and were considered ineligible for evaluation.
Arm/Group Title ENMD-2076
Hide Arm/Group Description:
ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of interrupted therapy for recovery from toxicities or intercurrent illness.
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
3
   7.9%
3.Secondary Outcome
Title Time to Disease Progression
Hide Description Length of time until disease progression in patients treated with ENMD-2076
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title ENMD-2076
Hide Arm/Group Description:
ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of interrupted therapy for recovery from toxicities or intercurrent illness.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Levels of Certain Proteins and Gene Expression Compared to Patient Outcome Following Treatment
Hide Description Association of somatic mutations in PIK3CA, ARID1A and PTEN mutation status, and ARID1A and PTEN expression assessed in archival samples and tumour biopsies with tumour response and patient outcome following treatment with ENMD 2076.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title ENMD-2076
Hide Arm/Group Description:
ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of interrupted therapy for recovery from toxicities or intercurrent illness.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame All AEs will be recorded in the source documents. All AEs, including clinically significant abnormal laboratory AEs, will be entered in the electronic CRFs from the time of the first dose of study medication until up to 30 days after the end of study drug administration or until alternate therapy is initiated, whichever occurs first.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ENMD-2076
Hide Arm/Group Description ENMD-2067 will be taken orally at a dose of 275 mg, once a day, everyday. Patients with a body surface area of less than 1.65 m2 will receive a starting dose of 250 mg, once a day, everyday. Patients will continue on therapy until disease progression or unacceptable toxicity. Dose reductions to 225mg and 150mg (200mg and 150mg for patients with body surface area under 1.65m2) are permitted, along with up to two weeks of therapy interruption for recovery from toxicity or intercurrent illness.
All-Cause Mortality
ENMD-2076
Affected / at Risk (%)
Total   0/40 (0.00%)    
Hide Serious Adverse Events
ENMD-2076
Affected / at Risk (%) # Events
Total   10/40 (25.00%)    
Cardiac disorders   
Hypertension   2/40 (5.00%)  3
Gastrointestinal disorders   
Abdominal Pain *  1/40 (2.50%)  2
Nausea & Vomiting *  1/40 (2.50%)  1
General disorders   
Dehydration *  1/40 (2.50%)  1
Dyaphagia *  1/40 (2.50%)  1
Psychiatric disorders   
Confusion *  2/40 (5.00%)  2
Reproductive system and breast disorders   
Vaginal Fistula *  1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary Embolism *  1/40 (2.50%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ENMD-2076
Affected / at Risk (%) # Events
Total   40/40 (100.00%)    
Blood and lymphatic system disorders   
Hypoalbuminemia *  15/40 (37.50%)  15
Anemia *  13/40 (32.50%)  13
Alkaline Phosphatase Increase *  11/40 (27.50%)  11
White Blood Cell Decrease *  9/40 (22.50%)  9
Hypocalcemia *  9/40 (22.50%)  9
AST Increased *  7/40 (17.50%)  7
Hypophosphatemia *  6/40 (15.00%)  6
ALT Increased *  6/40 (15.00%)  6
Hyponatremia *  4/40 (10.00%)  4
Endocrine disorders   
Elevated TSH *  9/40 (22.50%)  9
Hypothyroidism *  8/40 (20.00%)  8
Gastrointestinal disorders   
Nausea *  27/40 (67.50%)  27
Constipation *  23/40 (57.50%)  23
Diarrhea *  20/40 (50.00%)  20
Vomiting *  16/40 (40.00%)  16
General disorders   
Fatigue *  28/40 (70.00%)  28
Headache *  18/40 (45.00%)  18
Weight Loss *  15/40 (37.50%)  15
Mucositis *  8/40 (20.00%)  8
Metabolism and nutrition disorders   
Hypomagnesemia *  19/40 (47.50%)  19
Nervous system disorders   
Dysguesia *  10/40 (25.00%)  10
Dizziness *  9/40 (22.50%)  9
Renal and urinary disorders   
Proteinuria *  14/40 (35.00%)  14
Skin and subcutaneous tissue disorders   
Palmar-Plantar Erythrodysesthensia *  10/40 (25.00%)  10
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Amit Oza
Organization: University Health Network - Princess Margaret Cancer Centre
Phone: 416-946-2818
EMail: amit.oza@uhn.ca
Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01914510    
Other Study ID Numbers: ENMD-2076-OCC
First Submitted: July 11, 2013
First Posted: August 2, 2013
Results First Submitted: May 1, 2019
Results First Posted: December 13, 2019
Last Update Posted: December 13, 2019