Trial Outcomes & Findings for Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar (NCT NCT00476476)

Last Updated: 2015-05-07

Results Overview

Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).

Results posted on

2015-05-07

Participant Flow

Patients enrolled from February 2007 through July 2011.

Participant milestones

Participant milestones
Measure	Erlotinib-Cohort 1 Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.	Erlotinib-Cohort 2 Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
Overall Study STARTED	17	24
Overall Study Response Evaluable	17	23
Overall Study COMPLETED	15	0
Overall Study NOT COMPLETED	2	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib-Cohort 1 Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.	Erlotinib-Cohort 2 Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
Overall Study Adverse Event	2	7
Overall Study Progressive Disease	0	17

Baseline Characteristics

Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib-Cohort 1 n=17 Participants Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.	Erlotinib-Cohort 2 n=24 Participants Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.	Total n=41 Participants Total of all reporting groups
Age, Continuous	75 years n=5 Participants	71.5 years n=7 Participants	73 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	24 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	24 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).

Population: The analysis dataset is comprised of response evaluable patients.

Outcome measures

Outcome measures
Measure	Erlotinib-Cohort 1 n=17 Participants Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.	Erlotinib-Cohort 2 n=23 Participants Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
Response Rate	.35 proportion of participants Interval 0.167 to 0.58	.22 proportion of participants Interval 0.09 to 0.404

Adverse Events

Erlotinib

Serious events: 19 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib n=41 participants at risk Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
Investigations Death - disease progression NOS	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Blood and lymphatic system disorders Hemoglobin	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Ear and labyrinth disorders Hearing w/w-o audiogr in monitor prg	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Colitis	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Diarrhea w/o prior colostomy	17.1% 7/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Nausea	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Vomiting	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
General disorders Fatigue	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Infections and infestations Infection-other	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations Bilirubin	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations Creatinine	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Anorexia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Dehydration	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypercalcemia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hyperglycemia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypophosphatemia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypokalemia	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hyponatremia	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Musculoskeletal and connective tissue disorders Bone, pain	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Psychiatric disorders Confusion	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Renal and urinary disorders Renal failure	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Renal and urinary disorders Urinary retention	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Reproductive system and breast disorders Perineum, pain	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-other	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Rash/desquamation	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Hand-foot reaction	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.

Other adverse events

Other adverse events
Measure	Erlotinib n=41 participants at risk Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
Skin and subcutaneous tissue disorders Erythema multiforme	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Skin breakdown/decubitus ulcer	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Blood and lymphatic system disorders Hemoglobin	19.5% 8/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Blood and lymphatic system disorders Hematologic-other	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Cardiac disorders Sinus tachycardia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Endocrine disorders Endocrine-other	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Eye disorders Dry eye syndrome	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Eye disorders Eyelid dysfunction	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Eye disorders Tearing	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Eye disorders Ocular-other	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Constipation	9.8% 4/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Diarrhea w/o prior colostomy	56.1% 23/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Dry mouth	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Flatulence	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Dyspepsia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Nausea	14.6% 6/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Vomiting	17.1% 7/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders GI-other	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Abdomen, pain	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Gastrointestinal disorders Peritoneum, pain	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
General disorders Fatigue	56.1% 23/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
General disorders Fever w/o neutropenia	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
General disorders Edema limb	17.1% 7/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
General disorders Pain-other	19.5% 8/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
General disorders Flu-like syndrome	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Infections and infestations Infection w/ gr3-4 neut, anal/perianal	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Infections and infestations Infection Gr0-2 neut, lung	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Infections and infestations Infection Gr0-2 neut, oral cavity	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Infections and infestations Infection Gr0-2 neut, urinary tract	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Infections and infestations Infection w/ unk ANC urinary tract NOS	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Injury, poisoning and procedural complications Chemoradiation dermatitis	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations Leukocytes	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations Platelets	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations Weight loss	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations Alkaline phosphatase	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations ALT, SGPT	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations AST, SGOT	12.2% 5/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations Bilirubin	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations Creatinine	12.2% 5/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Investigations Metabolic/Laboratory-other	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Anorexia	26.8% 11/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Dehydration	17.1% 7/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypoalbuminemia	19.5% 8/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Bicarbonate	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypercalcemia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypocalcemia	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hyperglycemia	9.8% 4/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypermagnesemia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypomagnesemia	17.1% 7/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypophosphatemia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hyperkalemia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hypokalemia	9.8% 4/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Metabolism and nutrition disorders Hyponatremia	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Musculoskeletal and connective tissue disorders Back, pain	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Musculoskeletal and connective tissue disorders Buttock, pain	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Musculoskeletal and connective tissue disorders Neck, pain	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Nervous system disorders Taste disturbance	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Nervous system disorders Dizziness	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Nervous system disorders Head/headache	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Psychiatric disorders Anxiety	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Psychiatric disorders Depression	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Renal and urinary disorders Incontinence urinary	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Renal and urinary disorders Urinary frequency/urgency	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Renal and urinary disorders Renal/GU-other	9.8% 4/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Reproductive system and breast disorders Vagina, hemorrhage	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Reproductive system and breast disorders Perineum, pain	9.8% 4/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Reproductive system and breast disorders Vagina, pain	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Reproductive system and breast disorders Vaginal discharge (non-infectious	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Chylothorax	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Cough	14.6% 6/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-other	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Dry skin	29.3% 12/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Alopecia	14.6% 6/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Hyperpigmentation	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Nail changes	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Pruritus/itching	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Rash/desquamation	12.2% 5/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	41.5% 17/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Ulceration	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Skin-other	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Skin and subcutaneous tissue disorders Scalp, pain	2.4% 1/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Vascular disorders Hypertension	4.9% 2/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.
Vascular disorders Hemorrhage-other	7.3% 3/41 • Assessed from time of first dose, weekly during treatment and through 30 days post-treatment. Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3. Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.

Additional Information

Neil Horowitz MD

Dana-Farber Cancer Institute

Phone: 617.732.8843

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place