| The most common TEAEs in part A were diarrhea (47%), fatigue (47%), and nausea (47%) (Tables 2–4). |
| Six patients (19%) in part A had TEAEs that led to permanent treatment discontinuation (grade 3–4 events of hypercalcemia and increased lipase [treatment-related], and grade 5 events of breast cancer [progression], hyponatremia [treatment-related], hypoxia, and PE). Eighteen patients (56%) in part A had one or more serious adverse event (SAE), with four patients (13%) having any treatment-related SAE and with PE events (PE or embolism [16%]), pleural effusion (6%), and pneumonia (6%) the most common. There were 14 deaths (44%) that occurred during part A before study termination. The causes of death were breast, non-small cell lung, and colon or colorectal cancer in 10 patients and hyponatremia (treatment-related), hypoxia, pneumonia, and PE each in 1 patient. Six deaths occurred within 30 days of the last dose of SGN-2FF, but none were related to SGN-2FF treatment. Thromboembolic events (grade 2–5) occurred in 5 (16%) of 32 patients in the monotherapy dose escalation and dose finding cohorts in part A and in 1 (14%) of 7 patients during the SGN-2FF lead-in period for combination therapy dose escalation in part C. In the patient in part C who experienced a thromboembolic event, the event occurred after the eligibility and screening criteria were updated on November 17, 2018. There was no evidence of the patient having DVT based on the results of screening Doppler ultrasound, and the patient had been receiving mandatory thromboprophylaxis with LMWH. There was a grade 5 event of PE in one patient in part A. The median time to first TEAE of PE or embolism was 56.5 days, (range, 23–169). The dose levels at which PE occurred with SGN-2FF study treatment were 2, 5, and 15 g QD and 5 g b.i.d. |
| The most common TEAEs in part A were diarrhea (47%), fatigue (47%), and nausea (47%) (Tables 2–4). |
| Six patients (19%) in part A had TEAEs that led to permanent treatment discontinuation (grade 3–4 events of hypercalcemia and increased lipase [treatment-related], and grade 5 events of breast cancer [progression], hyponatremia [treatment-related], hypoxia, and PE). Eighteen patients (56%) in part A had one or more serious adverse event (SAE), with four patients (13%) having any treatment-related SAE and with PE events (PE or embolism [16%]), pleural effusion (6%), and pneumonia (6%) the most common. There were 14 deaths (44%) that occurred during part A before study termination. The causes of death were breast, non-small cell lung, and colon or colorectal cancer in 10 patients and hyponatremia (treatment-related), hypoxia, pneumonia, and PE each in 1 patient. Six deaths occurred within 30 days of the last dose of SGN-2FF, but none were related to SGN-2FF treatment. Thromboembolic events (grade 2–5) occurred in 5 (16%) of 32 patients in the monotherapy dose escalation and dose finding cohorts in part A and in 1 (14%) of 7 patients during the SGN-2FF lead-in period for combination therapy dose escalation in part C. In the patient in part C who experienced a thromboembolic event, the event occurred after the eligibility and screening criteria were updated on November 17, 2018. There was no evidence of the patient having DVT based on the results of screening Doppler ultrasound, and the patient had been receiving mandatory thromboprophylaxis with LMWH. There was a grade 5 event of PE in one patient in part A. The median time to first TEAE of PE or embolism was 56.5 days, (range, 23–169). The dose levels at which PE occurred with SGN-2FF study treatment were 2, 5, and 15 g QD and 5 g b.i.d. |
| The most common TEAEs in part A were diarrhea (47%), fatigue (47%), and nausea (47%) (Tables 2–4). |
| Six patients (19%) in part A had TEAEs that led to permanent treatment discontinuation (grade 3–4 events of hypercalcemia and increased lipase [treatment-related], and grade 5 events of breast cancer [progression], hyponatremia [treatment-related], hypoxia, and PE). Eighteen patients (56%) in part A had one or more serious adverse event (SAE), with four patients (13%) having any treatment-related SAE and with PE events (PE or embolism [16%]), pleural effusion (6%), and pneumonia (6%) the most common. There were 14 deaths (44%) that occurred during part A before study termination. The causes of death were breast, non-small cell lung, and colon or colorectal cancer in 10 patients and hyponatremia (treatment-related), hypoxia, pneumonia, and PE each in 1 patient. Six deaths occurred within 30 days of the last dose of SGN-2FF, but none were related to SGN-2FF treatment. Thromboembolic events (grade 2–5) occurred in 5 (16%) of 32 patients in the monotherapy dose escalation and dose finding cohorts in part A and in 1 (14%) of 7 patients during the SGN-2FF lead-in period for combination therapy dose escalation in part C. In the patient in part C who experienced a thromboembolic event, the event occurred after the eligibility and screening criteria were updated on November 17, 2018. There was no evidence of the patient having DVT based on the results of screening Doppler ultrasound, and the patient had been receiving mandatory thromboprophylaxis with LMWH. There was a grade 5 event of PE in one patient in part A. The median time to first TEAE of PE or embolism was 56.5 days, (range, 23–169). The dose levels at which PE occurred with SGN-2FF study treatment were 2, 5, and 15 g QD and 5 g b.i.d. |
| The most common TEAEs in part A were diarrhea (47%), fatigue (47%), and nausea (47%) (Tables 2–4). |
| Six patients (19%) in part A had TEAEs that led to permanent treatment discontinuation (grade 3–4 events of hypercalcemia and increased lipase [treatment-related], and grade 5 events of breast cancer [progression], hyponatremia [treatment-related], hypoxia, and PE). Eighteen patients (56%) in part A had one or more serious adverse event (SAE), with four patients (13%) having any treatment-related SAE and with PE events (PE or embolism [16%]), pleural effusion (6%), and pneumonia (6%) the most common. There were 14 deaths (44%) that occurred during part A before study termination. The causes of death were breast, non-small cell lung, and colon or colorectal cancer in 10 patients and hyponatremia (treatment-related), hypoxia, pneumonia, and PE each in 1 patient. Six deaths occurred within 30 days of the last dose of SGN-2FF, but none were related to SGN-2FF treatment. Thromboembolic events (grade 2–5) occurred in 5 (16%) of 32 patients in the monotherapy dose escalation and dose finding cohorts in part A and in 1 (14%) of 7 patients during the SGN-2FF lead-in period for combination therapy dose escalation in part C. In the patient in part C who experienced a thromboembolic event, the event occurred after the eligibility and screening criteria were updated on November 17, 2018. There was no evidence of the patient having DVT based on the results of screening Doppler ultrasound, and the patient had been receiving mandatory thromboprophylaxis with LMWH. There was a grade 5 event of PE in one patient in part A. The median time to first TEAE of PE or embolism was 56.5 days, (range, 23–169). The dose levels at which PE occurred with SGN-2FF study treatment were 2, 5, and 15 g QD and 5 g b.i.d. |
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