Table 2.

Cediranib-Related Toxicity During Cycle 1 by Dose Level and CTCAE (v.3) Grade

Toxicity	Dose Level (mg/m2/d) per Grade
	12 (n = 2)				8 (n = 3)				12 (n = 7)				17 (n = 4)
	1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4
Hematologic
Leukopenia										2
Neutropenia										1
GI
Abdominal pain					1				3				3	1
Anorexia					1	1			1				1	2*†
Constipation									1				2
Diarrhea	1‡				1				1		1§		1	3
Nausea			1¶		1				4				3		1‖
Stomatitis													1
Vomiting			1¶						1				1	1
Constitutional
Fatigue					1				3	1				1†
Lethargy			1¶
Weight loss					1				2				2
Cardiovascular
Prolonged QTc			1‡
Premature ventricular complexes	1‡
Decreased left ventricular function		1‡			2					1				1
Hypertension			1‡											1
Dermatologic
Palmar-plantar erythrodysesthesia									1	1			3
Pruritis									1
Endocrine
Hypothyroidism					1					1			1	1
Infection
Infection, Grade 1 or 2 ANC									1	1
Metabolic/laboratory
Increased AST		1¶												1
Increased ALT		1¶												1
Hypoalbuminemia										2
Hypoglycemia					1
Proteinuria					1
Pain
Chest													2
Headache										2			2
Renal/genitourinary
Cystitis					1

Abbreviation: QTc, corrected QT interval; ANC, absolute neutrophil count.

^*Grade 2 toxicity intolerable to the patient was defined as dose-limiting toxicity in the protocol.

^†Toxicity in patient 17.

^‡Toxicity in patient 02.

^§Toxicity in patient 12.

^¶Toxicity in patient 01.

^‖Toxicity in patient 13.

**Both participants enrolled at a starting dose of 12 mg/m²/d experienced dose-limiting toxicity. The protocol was amended to increase cardiac monitoring in subsequent cohorts. The cediranib dose was de-escalated to 8 mg/m²/d, then re-escalated to 12 mg/m²/d, then 17 mg/m²/d.