Trial Outcomes & Findings for A Study of ENMD-2076 in Ovarian Clear Cell Cancers (NCT NCT01914510)
NCT ID: NCT01914510
Last Updated: 2019-12-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
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.
Results posted on
2019-12-13
Participant Flow
Participant milestones
| Measure |
ENMD-2076
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.
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|---|---|
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Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
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38
|
|
Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of ENMD-2076 in Ovarian Clear Cell Cancers
Baseline characteristics by cohort
| Measure |
ENMD-2076
n=38 Participants
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.
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|---|---|
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Age, Continuous
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54 years
n=5 Participants
|
|
Sex: Female, Male
Female
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38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Prior Therapy
1 previous therapy
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22 Participants
n=5 Participants
|
|
Prior Therapy
2 previous therapies
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12 Participants
n=5 Participants
|
|
Prior Therapy
3 previous therapies
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4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
ENMD-2076
n=38 Participants
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.
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|---|---|
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Six Month Progression Free Survival Rate
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8 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 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.
Percentage of patients with complete or partial response as per RECIST 1.1 criteria.
Outcome measures
| Measure |
ENMD-2076
n=38 Participants
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.
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|---|---|
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Complete or Partial Response Rate
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3 Participants
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SECONDARY outcome
Timeframe: 2 yearsPopulation: Data not collected.
Length of time until disease progression in patients treated with ENMD-2076
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data not collected
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.
Outcome measures
Outcome data not reported
Adverse Events
ENMD-2076
Serious events: 10 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ENMD-2076
n=40 participants at risk
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.
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|---|---|
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Cardiac disorders
Hypertension
|
5.0%
2/40 • Number of events 3 • 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.
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|
Gastrointestinal disorders
Abdominal Pain
|
2.5%
1/40 • Number of events 2 • 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.
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|
Psychiatric disorders
Confusion
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5.0%
2/40 • Number of events 2 • 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.
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|
Reproductive system and breast disorders
Vaginal Fistula
|
2.5%
1/40 • Number of events 1 • 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.
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Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.5%
1/40 • Number of events 1 • 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.
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|
Gastrointestinal disorders
Nausea & Vomiting
|
2.5%
1/40 • Number of events 1 • 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.
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General disorders
Dehydration
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2.5%
1/40 • Number of events 1 • 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.
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|
General disorders
Dyaphagia
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2.5%
1/40 • Number of events 1 • 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.
|
Other adverse events
| Measure |
ENMD-2076
n=40 participants at risk
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.
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|---|---|
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General disorders
Fatigue
|
70.0%
28/40 • Number of events 28 • 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.
|
|
Gastrointestinal disorders
Nausea
|
67.5%
27/40 • Number of events 27 • 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.
|
|
Gastrointestinal disorders
Constipation
|
57.5%
23/40 • Number of events 23 • 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.
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Gastrointestinal disorders
Diarrhea
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50.0%
20/40 • Number of events 20 • 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.
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Metabolism and nutrition disorders
Hypomagnesemia
|
47.5%
19/40 • Number of events 19 • 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.
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General disorders
Headache
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45.0%
18/40 • Number of events 18 • 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.
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|
Gastrointestinal disorders
Vomiting
|
40.0%
16/40 • Number of events 16 • 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.
|
|
General disorders
Weight Loss
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37.5%
15/40 • Number of events 15 • 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.
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Blood and lymphatic system disorders
Hypoalbuminemia
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37.5%
15/40 • Number of events 15 • 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.
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|
Renal and urinary disorders
Proteinuria
|
35.0%
14/40 • Number of events 14 • 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.
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|
Blood and lymphatic system disorders
Anemia
|
32.5%
13/40 • Number of events 13 • 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.
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Blood and lymphatic system disorders
Alkaline Phosphatase Increase
|
27.5%
11/40 • Number of events 11 • 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.
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Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthensia
|
25.0%
10/40 • Number of events 10 • 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.
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Nervous system disorders
Dysguesia
|
25.0%
10/40 • Number of events 10 • 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.
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Blood and lymphatic system disorders
White Blood Cell Decrease
|
22.5%
9/40 • Number of events 9 • 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.
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Nervous system disorders
Dizziness
|
22.5%
9/40 • Number of events 9 • 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.
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|
Blood and lymphatic system disorders
Hypocalcemia
|
22.5%
9/40 • Number of events 9 • 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.
|
|
Endocrine disorders
Elevated TSH
|
22.5%
9/40 • Number of events 9 • 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.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
8/40 • Number of events 8 • 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.
|
|
General disorders
Mucositis
|
20.0%
8/40 • Number of events 8 • 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.
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|
Blood and lymphatic system disorders
AST Increased
|
17.5%
7/40 • Number of events 7 • 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.
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
15.0%
6/40 • Number of events 6 • 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.
|
|
Blood and lymphatic system disorders
ALT Increased
|
15.0%
6/40 • Number of events 6 • 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.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
10.0%
4/40 • Number of events 4 • 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.
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Additional Information
Dr. Amit Oza
University Health Network - Princess Margaret Cancer Centre
Phone: 416-946-2818
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place