Trial Outcomes & Findings for Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (NCT NCT01391962)

NCT ID: NCT01391962

Last Updated: 2026-02-02

Results Overview

Objective response rate is the combined partial and complete response rate, with those terms defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is disappearance of all non-target lesion and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Time on treatment (an average of 497 days or 16 months)

Results posted on

2026-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	AZD2171 (Cediranib) 30 mg Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Treatment assignment code 2. Part I: Participants will be randomized to receive sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), patients will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Part I STARTED	7	9	5	13
Part I Restaging	6	9	4	12
Part I Pharmacokinetic sampling	2	6	0	0
Part I COMPLETED	7	9	5	13
Part I NOT COMPLETED	0	0	0	0
Washout - 2 Weeks STARTED	0	9	0	13
Washout - 2 Weeks COMPLETED	0	9	0	13
Washout - 2 Weeks NOT COMPLETED	0	0	0	0
Part II STARTED	0	9	0	13
Part II Restaging	0	9	0	13
Part II Pharmacokinetic sampling	0	0	0	7
Part II COMPLETED	0	9	0	13
Part II NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sunitinib or Cediranib for Alveolar Soft Part Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD2171 (Cediranib) 30 mg n=7 Participants Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=9 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg n=5 Participants Treatment assignment code 2. Part I: Participants will be randomized to receive sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), patients will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=13 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants	1 Participants n=15 Participants	0 Participants n=28 Participants	1 Participants n=2 Participants	2 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=13 Participants	8 Participants n=15 Participants	5 Participants n=28 Participants	11 Participants n=2 Participants	31 Participants n=32 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	1 Participants n=2 Participants	1 Participants n=32 Participants
Age, Continuous	26.67 years STANDARD_DEVIATION 11.03 • n=13 Participants	26.6 years STANDARD_DEVIATION 6.03 • n=15 Participants	30.88 years STANDARD_DEVIATION 17.74 • n=28 Participants	32.87 years STANDARD_DEVIATION 13.72 • n=2 Participants	29.64 years STANDARD_DEVIATION 12.09 • n=32 Participants
Sex: Female, Male Female	2 Participants n=13 Participants	2 Participants n=15 Participants	1 Participants n=28 Participants	2 Participants n=2 Participants	7 Participants n=32 Participants
Sex: Female, Male Male	5 Participants n=13 Participants	7 Participants n=15 Participants	4 Participants n=28 Participants	11 Participants n=2 Participants	27 Participants n=32 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=13 Participants	0 Participants n=15 Participants	1 Participants n=28 Participants	0 Participants n=2 Participants	3 Participants n=32 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=13 Participants	9 Participants n=15 Participants	4 Participants n=28 Participants	13 Participants n=2 Participants	31 Participants n=32 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants	2 Participants n=15 Participants	1 Participants n=28 Participants	3 Participants n=2 Participants	6 Participants n=32 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	1 Participants n=15 Participants	0 Participants n=28 Participants	1 Participants n=2 Participants	2 Participants n=32 Participants
Race (NIH/OMB) Black or African American	1 Participants n=13 Participants	5 Participants n=15 Participants	0 Participants n=28 Participants	4 Participants n=2 Participants	10 Participants n=32 Participants
Race (NIH/OMB) White	6 Participants n=13 Participants	1 Participants n=15 Participants	4 Participants n=28 Participants	5 Participants n=2 Participants	16 Participants n=32 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=28 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants
Region of Enrollment United States	7 participants n=13 Participants	9 participants n=15 Participants	5 participants n=28 Participants	13 participants n=2 Participants	34 participants n=32 Participants

PRIMARY outcome

Timeframe: Time on treatment (an average of 497 days or 16 months)

Population: A total of 15/34 participants were analyzed: 15/16 participants who received cediranib in Part I were analyzed (1 participant was not evaluable for response).

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg n=6 Participants Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=9 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) Complete Response	0 Participants	0 Participants	—	—
Part I: Objective Response Rate (ORR) of Single-agent Cediranib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) Partial Response	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: Time on treatment (an average of 497 days or 16 months)

Population: A total of 14/34 participants were analyzed: 14/18 participants who received sunitinib in Part I were analyzed (4 participants who received sunitinib were not evaluable for response.

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg n=4 Participants Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=10 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) Complete Response	0 Participants	0 Participants	—	—
Part I: Objective Response Rate (ORR) of Single-agent Sunitinib in Participants With Advanced Alveolar Soft Part Sarcoma (ASPS) Partial Response	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: Time on treatment (an average of 497 days or 16 months)

Population: A total of 9/34 participants were analyzed: 9/9 participants who received sunitinib in Part II were analyzed.

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg n=9 Participants Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Part II: Objective Response Rate (ORR) of Sunitinib in Participants Who Progress on the Cediranib Arm During Part I Complete Response	0 Participants	—	—	—
Part II: Objective Response Rate (ORR) of Sunitinib in Participants Who Progress on the Cediranib Arm During Part I Partial Response	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Time on treatment (an average of 497 days or 16 months)

Population: A total of 10/34 participants were analyzed: 10/13 participants who received cediranib in Part II were analyzed (3 participants were not evaluable for response).

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg n=10 Participants Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Part II: Objective Response Rate (ORR) of Cediranib in Participants Who Progress on the Sunitinib Arm During Part I Complete Response	0 Participants	—	—	—
Part II: Objective Response Rate (ORR) of Cediranib in Participants Who Progress on the Sunitinib Arm During Part I Partial Response	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Before first dose on Cycle 1 day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 28 days)

Population: A total of 15/34 participants were analyzed: 15/29 participants who received cediranib in either Part I or Part II were analyzed.

Pharmacokinetic analysis was performed on blood samples from participants on cediranib (both upfront therapy and following cross-over). Human plasma samples were analyzed using a validated liquid chromatography-mass spectrometry (LC-MS) method and the maximum observed analyte concentration in plasma will be reported. No sampling or analysis will be done for participants receiving sunitinib.

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg n=2 Participants Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=6 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=7 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Maximum Observed Plasma Concentration of Cediranib	108 Nanomolar Interval 47.0 to 168.0	115 Nanomolar Interval 36.0 to 219.0	126 Nanomolar Interval 54.0 to 194.0	—

SECONDARY outcome

Timeframe: 24 weeks

24-week PFS is defined as the probability of participants remaining alive and progression-free at 24 weeks after the start of treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg n=7 Participants Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=9 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=5 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=13 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Percentage of Participants With Progression-free Survival (PFS) at 24 Weeks for Participants Receiving Single-agent Cediranib and Single-agent Sunitinib Malate in Participants With Advanced ASPS During Part I	62.5 Percentage of participants Interval 29.5 to 76.2	62.5 Percentage of participants Interval 29.5 to 76.2	50.0 Percentage of participants Interval 25.9 to 70.1	50.0 Percentage of participants Interval 25.9 to 70.1

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, an average of 523 days

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg n=7 Participants Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=9 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=5 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=13 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	7 Participants	9 Participants	4 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Time on treatment (an average of 497 days or 16 months)

Population: A total of 11/34 participants were analyzed: of the 14 participants who were not newly diagnosed, 2 participants randomized to receive sunitinib and 1 participant randomized to receive cediranib in Part I were not evaluable for response, leaving only 11 reportable participants.

Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is disappearance of all non-target lesion and normalization of tumor marker level. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. Progression is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=3 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=1 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=7 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Best Overall Response During Part I for Participants Who Were Not Newly Diagnosed Complete Response	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response During Part I for Participants Who Were Not Newly Diagnosed Partial Response	0 Participants	0 Participants	0 Participants	1 Participants
Best Overall Response During Part I for Participants Who Were Not Newly Diagnosed Stable Disease	0 Participants	3 Participants	1 Participants	5 Participants
Best Overall Response During Part I for Participants Who Were Not Newly Diagnosed Progressive Disease	0 Participants	0 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: A total of 14/34 participants were analyzed. 20 participants not analyzed were newly diagnosed. The outcome is for non-newly diagnosed participants only.

24-week PFS is defined as the probability of patients remaining alive and progression-free at 24 weeks after the start of treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg n=1 Participants Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=3 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=2 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=8 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Percentage of Participants With Progression-free Survival (PFS) at 24 Weeks During Part I for Participants Who Were Not Newly Diagnosed	50.0 Percentage of participants Interval 5.8 to 84.5	50.0 Percentage of participants Interval 5.8 to 84.5	40.0 Percentage of participants Interval 12.3 to 67.0	40.0 Percentage of participants Interval 12.3 to 67.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Time on treatment (an average of 497 days or 16 months)

Population: A total of 10/34 participants were analyzed: of the 11 participants who were not newly diagnosed and participated in Part II of the trial, 1 participant (who was randomized to receive sunitinib in Part I and then crossed over to receive cediranib in Part II) was not evaluable for response, leaving only 10 reportable participants.

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=3 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=7 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Best Overall Response During Part II for Participants Who Were Not Newly Diagnosed Complete Response	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response During Part II for Participants Who Were Not Newly Diagnosed Partial Response	0 Participants	0 Participants	0 Participants	1 Participants
Best Overall Response During Part II for Participants Who Were Not Newly Diagnosed Stable Disease	0 Participants	2 Participants	0 Participants	3 Participants
Best Overall Response During Part II for Participants Who Were Not Newly Diagnosed Progressive Disease	0 Participants	1 Participants	0 Participants	2 Participants
Best Overall Response During Part II for Participants Who Were Not Newly Diagnosed Not Scanned	0 Participants	0 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: 11/34 participants were analyzed: all 11 participants who were not newly diagnosed and participated in Part II of the trial were analyzed. 20 participants were not analyzed as they were newly diagnosed and this outcome is for non-newly diagnosed participants only. In addition, 3 participants who were not newly diagnosed did not participate in Part II of the trial, leaving 11 participants who were not newly diagnosed and who participated in Part II of the trial, for whom this outcome is reported.

Outcome measures

Outcome measures
Measure	AZD2171 (Cediranib) 30 mg Treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	AZD2171 (Cediranib) 30 mg Followed by Sunitinib Malate 37.5 mg n=3 Participants Treatment assignment code 1 followed by treatment assignment code 2. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 participants are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 patients have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).	Sunitinib Malate 37.5 mg Followed by AZD2171 (Cediranib) 30 mg n=8 Participants Treatment assignment code 2 followed by treatment assignment code 1. Part I: Participants will be randomized to receive cediranib (30 mg) or sunitinib malate (37.5 mg) orally, once a day, in 28-day cycles. Part I is a two-stage design in which 10 patients are initially enrolled in each arm. If 0 or 1 of the 10 participants has a clinical response, then no further participants will be accrued. That treatment arm will be closed to the accrual of new participants and the crossover of participants who progressed on the other agent. If 2 or more the first 10 participants have a response, then accrual would continue until a total of 22 participants have enrolled in that arm. Part II: At the time of disease progression (documented by Response Evaluation Criteria in Solid Tumors (RECIST v1), participants will cross over to the other treatment arm after a 2-week wash-out period (unless the other arm has been closed due to inadequate activity or unacceptable toxicity).
Percentage of Participants With Progression-free Survival (PFS) at 24 Weeks During Part II for Participants Who Were Not Newly Diagnosed	—	33.3 percentage of participants Interval 0.9 to 77.4	—	57.1 percentage of participants Interval 17.2 to 83.7

Adverse Events

AZD2171 (Cediranib) 30 mg

Serious events: 7 serious events

Other events: 28 other events

Deaths: 0 deaths

Sunitinib Malate 37.5 mg

Serious events: 7 serious events

Other events: 26 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Alice P. Chen

National Cancer Institute

Phone: 240-781-3320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place