Trial Outcomes & Findings for Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer (NCT NCT00478426)

NCT ID: NCT00478426

Last Updated: 2020-02-17

Results Overview

Objective response rate, defined as the rate of complete or partial response as defined by the Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), disappearance of all target lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: Up to 7 years
• Results posted on: 2020-02-17

Participant Flow

Participant milestones

Measure	Treatment (Sunitinib Malate) Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Overall Study STARTED	34
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment (Sunitinib Malate) Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Treatment (Sunitinib Malate) n=34 Participants Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Age, Continuous	65 years n=34 Participants
Sex: Female, Male Female	34 Participants n=34 Participants
Sex: Female, Male Male	0 Participants n=34 Participants
Region of Enrollment Canada	22 participants n=34 Participants
Region of Enrollment United States	12 participants n=34 Participants
Endometrioid Subtype	24 Participants n=34 Participants
Serous Subtype	6 Participants n=34 Participants
Carcinosarcoma Subtype	3 Participants n=34 Participants
Number of Lines of Previous Therapies 0 prior lines of therapy	9 Participants n=34 Participants
Number of Lines of Previous Therapies 1 prior line of therapy	17 Participants n=34 Participants
Number of Lines of Previous Therapies 2 prior lines of therapy	8 Participants n=34 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Population: Of the 33 participants, only 28 were considered evaluable for response.

Objective response rate, defined as the rate of complete or partial response as defined by the Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), disappearance of all target lesions.

Outcome measures

Measure	Treatment (Sunitinib Malate) n=33 Participants Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Objective Response Rate Stable Disease	6 Participants
Objective Response Rate Progressive Disease	16 Participants
Objective Response Rate non-evaluable patient	5 Participants
Objective Response Rate Partial Response	6 Participants

SECONDARY outcome

Timeframe: Up to 7 years

Population: Of the 33 participants, 28 were considered evaluable for response. 5 of these patients were not fully evaluable for the study as they were removed before first radiological assessment but are nonetheless included in denominator for response assessment.

Described as the best response of stable disease that is maintained for atleast 6 months

Outcome measures

Measure	Treatment (Sunitinib Malate) n=33 Participants Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Number of Participants With Prolonged Stable Disease	0 Participants

SECONDARY outcome

Timeframe: Up to 7 years

Population: Of the 33 participants, 28 were considered evaluable for response. 5 of these patients were not fully evaluable for the study as they were removed before first radiological assessment but are nonetheless included in denominator for response assessment.

Estimated using the Kaplan-Meier method.

Outcome measures

Measure	Treatment (Sunitinib Malate) n=33 Participants Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Overall Survival	19.4 months Interval 6.2 to 60.0

SECONDARY outcome

Timeframe: Up to 7 years

Population: Of the 33 participants, 28 were considered evaluable for response. 5 of these patients were not fully evaluable for the study as they were removed before first radiological assessment but are nonetheless included in denominator for response assessment.

Number of participants that experience at east 1 adverse event while on trial, according to the CTCAE.

Outcome measures

Measure	Treatment (Sunitinib Malate) n=33 Participants Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Number of Participants With Adverse Effects Assessed by CTCAE Version 3.0	30 Participants

SECONDARY outcome

Timeframe: Up to 7 years

The length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body. Assessed by Kaplan and Meier method

Outcome measures

Measure	Treatment (Sunitinib Malate) n=33 Participants Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Time to Progression	3 months Interval 2.5 to 5.3

Adverse Events

Treatment (Sunitinib Malate)

Serious events: 30 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Sunitinib Malate) n=33 participants at risk Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Blood and lymphatic system disorders Neutropenia	24.2% 8/33 • Number of events 8 • Adverse events were collected from baseline, onward to end of treatment up to 5 years total.
Blood and lymphatic system disorders Anemia	9.1% 3/33 • Number of events 3 • Adverse events were collected from baseline, onward to end of treatment up to 5 years total.
Blood and lymphatic system disorders Thrombocytopenia	9.1% 3/33 • Number of events 3 • Adverse events were collected from baseline, onward to end of treatment up to 5 years total.
General disorders Fatigue	42.4% 14/33 • Number of events 14 • Adverse events were collected from baseline, onward to end of treatment up to 5 years total.
Cardiac disorders Hypertension	18.2% 6/33 • Number of events 6 • Adverse events were collected from baseline, onward to end of treatment up to 5 years total.

Other adverse events

Measure	Treatment (Sunitinib Malate) n=33 participants at risk Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Sunitinib Malate: Given PO
Gastrointestinal disorders Diarrhea	75.8% 25/33 • Number of events 25 • Adverse events were collected from baseline, onward to end of treatment up to 5 years total.
Gastrointestinal disorders Dyspepsia	51.5% 17/33 • Number of events 17 • Adverse events were collected from baseline, onward to end of treatment up to 5 years total.
General disorders Oral Mucositis	51.5% 17/33 • Number of events 17 • Adverse events were collected from baseline, onward to end of treatment up to 5 years total.
Gastrointestinal disorders Nausea	57.6% 19/33 • Number of events 19 • Adverse events were collected from baseline, onward to end of treatment up to 5 years total.

Additional Information

Dr. Amit Oza

University Health Network - Princess Margaret Cancer Centre

Phone: 416-946-2082

Email: amit.oza@uhn.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60