Study to Evaluate the Safety and Efficacy of NKTR-102 in... | NCT00806156

Label	Type	Description	Intervention Names
NKTR-102 q14d	Experimental	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.	Drug: NKTR-102 q14d
NKTR-102 q21d	Experimental	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.	Drug: NKTR-102 q21d

Name	Type	Description	Arm Group Labels	Other Names
NKTR-102 q14d	Drug	NKTR-102 given on a q14 day schedule	NKTR-102 q14d

Measure	Description	Time Frame
Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population	The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. The analysis was performed for patients in the Primary Efficacy Population.	Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

Measure	Description	Time Frame
Secondary: Best Overall Response by Gynecologic Cancer Intergroup (GCIG) Criteria: MITT Population	Best overall response was defined as the proportion of patients with a CR or a PR as assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and cancer antigen 125 (CA-125) criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the upper limit of normal (ULN) and within 2 weeks prior to starting treatment." Analysis was performed in MITT Population.

Name	Affiliation	Role
Study Director	Nektar Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigator Site - Higland		Highland	California	92346	United States
Investigator Site - Los Angeles

PubMed Identifier	Type	Citation	Retractions
28935273	Derived	Rustin G, Vergote I, Micha JP, Duska LR, Reed N, Bendell J, Spitz D, Dark G, Hoch U, Tagliaferri M, Hannah AL, Garcia AA. A multicenter, open-label, expanded phase 2 study to evaluate the safety and efficacy of etirinotecan pegol, a polymer conjugate of irinotecan, in women with recurrent platinum-resistant or refractory ovarian cancer. Gynecol Oncol. 2017 Nov;147(2):276-282. doi: 10.1016/j.ygyno.2017.08.026. Epub 2017 Sep 19.

ID	Title	Description
FG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients.
FG001	NKTR-102 q21d

Primary

Primary: Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST): Primary Efficacy Population

The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. The analysis was performed for patients in the Primary Efficacy Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	Primary Efficacy Population	The primary efficacy population consisted of patients in the modified intent-to-treat population (MITT) treated in q21d treatment schedule with platinum-resistant ovarian cancer who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.

Units	Counts
Participants	OG000104 OG001104

Title

Denominators

Categories

Title	Measurements
	OG00014.4(8.3 to 22.7) OG00114.4(8.3 to 22.7)

Secondary

Secondary: Best Overall Response by Gynecologic Cancer Intergroup (GCIG) Criteria: MITT Population

Best overall response was defined as the proportion of patients with a CR or a PR as assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and cancer antigen 125 (CA-125) criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the upper limit of normal (ULN) and within 2 weeks prior to starting treatment." Analysis was performed in MITT Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Best Overall Response by GCIG Criteria: Primary Efficacy Population

Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Primary Efficacy Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Best Overall Response by GCIG Criteria: Platinum-Refractory Population

Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Platinum-Refractory Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Best Overall Response by GCIG Criteria: Prior PLD Therapy Population

Best overall response was defined as the proportion of patients with a CR or a PR per assessed per GCIG criteria. The GCIG proposed the following definition for the date of progression which used both the RECIST and CA-125 criteria. "A response according to CA-125 has occurred if there is ≥ 50% reduction in CA-125 levels from a pretreatment sample. The response had to be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they had a pretreatment sample that was at least twice the ULN and within 2 weeks prior to starting treatment." Analysis was performed in Prior PLD Therapy Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Kaplan-Meier Estimate of Progression-Free Survival (PFS): MITT Population

According to enhanced RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR an unambiguous increase in the sum of target lesion volumes with both 1) >20% increase in the sum of volumes (SOV) of all target lesions (taking as reference the nadir) and 2) greater than two times the variability of the measurements estimated by the sponsor and/or its designees.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	NKTR-102 q21d

Secondary

Secondary: Kaplan-Meier Estimate of PFS: Primary Efficacy Population

PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Primary Efficacy Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites..
OG001

Secondary

Secondary: Kaplan-Meier Estimate of PFS: Platinum-Refractory Population

PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Platinum-Refractory Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Kaplan-Meier Estimate of PFS: Prior PLD Therapy Population

PFS was defined as the time from the date of the first NKTR-102 administration to the date of PD or death due to any cause. Progressive disease was determined by Investigators using RECIST criteria. Patients who were alive without disease progression at the time of data-cut-off were censored at the time of the last tumor assessment that demonstrated a lack of disease progression (or on Cycle 1 Day 1 if the patient did not undergo repeated imaging while on study). Analysis was performed in Prior PLD Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001

Secondary

Secondary: Kaplan-Meier Analysis of Duration of Overall Response (DoR): MITT Population

DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in MITT Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001

Secondary

Secondary: Kaplan-Meier Analysis of DoR: Primary Efficacy Population

DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Primary Efficacy Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	Primary Efficacy Population

Secondary

Secondary: Kaplan-Meier Analysis of DoR: Platinum-Refractory Population

DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Platinum-Refractory Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001

Secondary

Secondary: Kaplan-Meier Analysis of DoR: Prior PLD Therapy Population

DoR was defined as the time from the first documented CR or PR, the date of PD (assessed by central radiological review according to RECIST), or death due to any cause, whichever came first. Patients who were alive without documented PD per RECIST were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease, whichever was earlier. Analysis was performed in Prior PLD Therapy Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	NKTR-102 q21d

Secondary

Secondary: CA-125 Response Rate: MITT Population

CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in MITT Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	NKTR-102 q21d

Secondary

Secondary: CA-125 Response Rate: Primary Efficacy Population

CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Primary Efficacy Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001

Secondary

Secondary: CA-125 Response Rate: Platinum-Refractory Population

CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Platinum-Refractory Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001

Secondary

Secondary: CA-125 Response Rate: Prior PLD Therapy Population

CA-125 response was determined by having achieved a ≥50% reduction in serum levels of CA-125 from a pre-treatment level of at least twice the ULN within 2 weeks of starting treatment according to the GCIG criteria. The CA-125 response rate was calculated as the number of patients meeting the endpoint definition divided by the total number of eligible patients per the GCIG criteria for CA-125 in the analysis population. Analysis was performed in Prior PLD Therapy Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001

Secondary

Secondary: Clinical Benefit Rate: MITT Population

Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in MITT Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Clinical Benefit Rate: Primary Efficacy Population

Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Primary Efficacy Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	Primary Efficacy Population	The primary efficacy population consisted of patients with platinum-resistant ovarian cancer in the modified intent-to-treat population (MITT) treated in q21d treatment schedule who had received prior pegylated liposomal doxorubicin (PLD) therapy in a platinum-resistant setting or were otherwise unable to receive further PLD therapy.

Secondary

Secondary: Clinical Benefit Rate: Platinum-Refractory Population

Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Platinum-Refractory Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Clinical Benefit Rate: Prior PLD Therapy Population

Clinical benefit rate was calculated as the number of patients with confirmed CR, PR, or SD (where the duration of SD should be ≥ 3 months) by RECIST divided by the total number of measurable patients in the population. Analysis was performed in Prior PLD Therapy Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Kaplan-Meier Analysis of Overall Survival (OS): MITT Population

Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in MITT Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Kaplan-Meier Analysis of OS: Primary Efficacy Population

Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Primary Efficacy Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Kaplan-Meier Analysis of OS: Platinum-Refractory Population

Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Platinum-Refractory Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: Kaplan-Meier Analysis of OS: Prior PLD Therapy Population

Duration of OS was defined as the time from the date of randomization to the date of death due to any cause. Patients were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. Patients who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Patients who did not have any follow-up since the date of randomization were censored at the date of randomization. Analysis was performed in Prior PLD Therapy Population.

Received at least one dose of study treatment

Posted

Median

95% Confidence Interval

Months

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: ORR by RECIST: MITT Population

The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the MITT Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: ORR by RECIST: Prior PLD Population

The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the PLD Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
OG001	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.

Secondary

Secondary: ORR by RECIST: Platinum-Refractory Population

The ORR was defined as the proportion of patients with a CR or a PR per RECIST 1.0 based upon the best response as assessed by the Investigator assessment. The analysis was performed for patients in the Platinum-Refractory Population.

Received at least one dose of study treatment

Posted

Number

95% Confidence Interval

Percentage of Patients

Every 6 weeks (± 5 days) from Cycle 1, Day 1 until documented disease progression, start of new therapy for cancer, death, or end of study (approximately 3 years and 11 months)

ID	Title	Description
OG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites and shortly thereafter included in Protocol Amendment 1.0 dated 26 Mar 2009.
OG001	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites and shortly thereafter included in Protocol Amendment 1.0 dated 26 Mar 2009.

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.	35	38	23	38	38	38
EG001	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.	95	139	78	139	139	139

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Deep vein thrombosis	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Contrast media allergy	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Hypersensitivity	Immune system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected139 at risk
Death	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Disease progression	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected38 at risk EG00111 events11 affected139 at risk
Fatigue	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
General physical health deterioration	General disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Oedema peripheral	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Pyrexia	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0014 events4 affected139 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Blood potassium decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Body temperature increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Hepatic enzyme increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Lipase increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Angina pectoris	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Pleural effusion	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG0014 events4 affected139 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0013 events3 affected139 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected38 at risk EG0011 events1 affected139 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0013 events3 affected139 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events2 affected38 at risk EG0011 events1 affected139 at risk
Thrombocytopenia subjects affected /	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events2 affected139 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Cholinergic syndrome	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Complex partial seizures	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Speech disorder	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected38 at risk EG0018 events7 affected139 at risk
Ascites	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0013 events2 affected139 at risk
Colonic obstruction	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00010 events9 affected38 at risk EG00124 events21 affected139 at risk
Gastritis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Ileus	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG0017 events7 affected139 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events2 affected139 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0011 events1 affected139 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0018 events7 affected139 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG00119 events11 affected139 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG00110 events9 affected139 at risk
Renal failure	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected38 at risk EG0011 events1 affected139 at risk
Renal impairment	Renal and urinary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events7 affected38 at risk EG00115 events13 affected139 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected38 at risk EG0010 events0 affected139 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Clostridial infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events2 affected139 at risk
Fungal oesophagitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Gastroenteritis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events1 affected139 at risk
Herpes oesophagitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Lobar pneumonia	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events2 affected139 at risk
Respiratory tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0012 events2 affected139 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG0011 events1 affected139 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0010 events0 affected139 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG0013 events2 affected139 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Flushing	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events1 affected38 at risk EG00113 events9 affected139 at risk
Hypotension	Vascular disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events3 affected38 at risk EG0016 events6 affected139 at risk
Asthenia	General disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events3 affected38 at risk EG00116 events12 affected139 at risk
Chills	General disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected38 at risk EG00111 events7 affected139 at risk
Fatigue	General disorders	MedDRA (12.1)	Systematic Assessment	EG00038 events20 affected38 at risk EG001198 events81 affected139 at risk
Oedema peripheral	General disorders	MedDRA (12.1)	Systematic Assessment	EG00010 events7 affected38 at risk EG00120 events15 affected139 at risk
Pyrexia	General disorders	MedDRA (12.1)	Systematic Assessment	EG00015 events11 affected38 at risk EG00133 events23 affected139 at risk
Anxiety	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events7 affected38 at risk EG00112 events12 affected139 at risk
Depression	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG00113 events11 affected139 at risk
Insomnia	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events7 affected38 at risk EG00120 events15 affected139 at risk
Blood creatinine increased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG00114 events10 affected139 at risk
Haemoglobin decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG00116 events8 affected139 at risk
Weight decreased	Investigations	MedDRA (12.1)	Systematic Assessment	EG00031 events18 affected38 at risk EG00151 events42 affected139 at risk
Tachycardia	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events2 affected38 at risk EG0017 events7 affected139 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG00019 events10 affected38 at risk EG00165 events38 affected139 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG00143 events13 affected139 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG00022 events9 affected38 at risk EG00174 events27 affected139 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events1 affected38 at risk EG00114 events8 affected139 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events7 affected38 at risk EG00114 events13 affected139 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events6 affected38 at risk EG00139 events28 affected139 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG0017 events6 affected139 at risk
Dizziness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG00017 events11 affected38 at risk EG00136 events25 affected139 at risk
Dysgeusia	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events8 affected38 at risk EG00124 events17 affected139 at risk
Headache	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG00013 events6 affected38 at risk EG00142 events23 affected139 at risk
Lethargy	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events2 affected38 at risk EG00113 events8 affected139 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected38 at risk EG0018 events6 affected139 at risk
Vision blurred	Eye disorders	MedDRA (12.1)	Systematic Assessment	EG00014 events9 affected38 at risk EG00141 events26 affected139 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events7 affected38 at risk EG00119 events17 affected139 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00021 events16 affected38 at risk EG001128 events74 affected139 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0000 events0 affected38 at risk EG00111 events10 affected139 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG00122 events15 affected139 at risk
Ascites	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG00112 events8 affected139 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00012 events9 affected38 at risk EG00187 events51 affected139 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG000230 events34 affected38 at risk EG001376 events103 affected139 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected38 at risk EG0016 events5 affected139 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00014 events8 affected38 at risk EG00130 events17 affected139 at risk
Flatulence	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00010 events8 affected38 at risk EG00119 events16 affected139 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00070 events27 affected38 at risk EG001250 events107 affected139 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0008 events3 affected38 at risk EG00120 events17 affected139 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG00054 events23 affected38 at risk EG001176 events76 affected139 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG00016 events12 affected38 at risk EG00135 events29 affected139 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events3 affected38 at risk EG00112 events11 affected139 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0009 events7 affected38 at risk EG00123 events17 affected139 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0007 events5 affected38 at risk EG00111 events8 affected139 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events4 affected38 at risk EG00116 events15 affected139 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG00125 events16 affected139 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected38 at risk EG00116 events10 affected139 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events4 affected38 at risk EG00115 events8 affected139 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0003 events3 affected38 at risk EG00113 events11 affected139 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00035 events20 affected38 at risk EG001135 events69 affected139 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00020 events11 affected38 at risk EG00123 events22 affected139 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0005 events2 affected38 at risk EG00110 events7 affected139 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG00024 events18 affected38 at risk EG00161 events28 affected139 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0004 events4 affected38 at risk EG00116 events8 affected139 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected38 at risk EG00128 events15 affected139 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 events5 affected38 at risk EG0017 events6 affected139 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0005 events3 affected38 at risk EG0018 events7 affected139 at risk
Urinary tract infection	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0007 events6 affected38 at risk EG00122 events11 affected139 at risk

ID	Term
D009369	Neoplasms
D010051	Ovarian Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders

ID	Title	Description
BG000	NKTR-102 q14d	NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 4 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
BG001	NKTR-102 q21d	NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week [± 2 days] cycle at a dose of 170 mg/m^2 for the first 6 patients enrolled and at a dose of 145 mg/m^2 for the remainder of the patients. Note: NKTR-102 was administered at a dose level of 170 mg/m2 (10 patients enrolled and received this dose for 1 to 3 cycles) until the dose was reduced to 145 mg/m2 for all ongoing patients in the q14d and q21d treatment schedules and this became the starting dose for all newly enrolled patients. The dose was reduced based on safety results from ongoing NKTR-102 Phase 1 and 2 clinical studies and the reduction was initiated with a waiver for study sites.
BG002	Total	Total of all reporting groups