Trial Outcomes & Findings for Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial (NCT NCT01294358)

Last Updated: 2019-11-13

Results Overview

Here is the number of participants with DLT. DLT is defined as follows: All grade 3 or greater toxicities with the exception of Grade 3 constitutional symptoms that persist for less than 72 hours, Grade 3 and 4 myelosuppression (neutrophils and thrombocytopenia) of less than 5 days duration. Grade 3 metabolic/laboratory events that are correctable within 24 hours. Events that are assessed by the principal investigator as clearly unrelated to the agent will not be considered DLTs (e.g., events directly related to catheter insertion, pain related to underlying disease).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

Cycle 1 (4 weeks), for up to 6 cycles

Results posted on

2019-11-13

Participant Flow

7 patients were enrolled, but only 6 were treated. Patient # 7 was consented and registered but developed pancreatitis before treatment. This patient was not treated.

Participant milestones

Participant milestones
Measure	18 mg/m(2)/24h All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h. All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Cohort 1: 5/11/11-11/9/11 STARTED	4	0	0	0	0
Cohort 1: 5/11/11-11/9/11 COMPLETED	4	0	0	0	0
Cohort 1: 5/11/11-11/9/11 NOT COMPLETED	0	0	0	0	0
Cohort 2: 6/9/11-9/17/12 STARTED	0	6	0	0	0
Cohort 2: 6/9/11-9/17/12 COMPLETED	0	4	0	0	0
Cohort 2: 6/9/11-9/17/12 NOT COMPLETED	0	2	0	0	0
Cohort 3: 12/1/11-10/6/12 STARTED	0	0	4	0	0
Cohort 3: 12/1/11-10/6/12 COMPLETED	0	0	2	0	0
Cohort 3: 12/1/11-10/6/12 NOT COMPLETED	0	0	2	0	0
Cohort 4: 12/30/11-2/17/17 STARTED	0	0	0	2	0
Cohort 4: 12/30/11-2/17/17 COMPLETED	0	0	0	1	0
Cohort 4: 12/30/11-2/17/17 NOT COMPLETED	0	0	0	1	0
Cohort 5: 3/8/12-3/9/12 STARTED	0	0	0	0	1
Cohort 5: 3/8/12-3/9/12 COMPLETED	0	0	0	0	0
Cohort 5: 3/8/12-3/9/12 NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	36 mg/m(2)/24h All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h. All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Cohort 2: 6/9/11-9/17/12 Disease progression	2	0	0	0
Cohort 3: 12/1/11-10/6/12 Disease progression	0	2	0	0
Cohort 4: 12/30/11-2/17/17 pt rec'd surgical resection of pancreas	0	0	1	0
Cohort 5: 3/8/12-3/9/12 dose limiting toxicity grade 4	0	0	0	1

Baseline Characteristics

Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=7 Participants All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h, 36 mg/m(2)/24h, 72 mg/m(2)/24h, 96 mg/m(2)/24h, and/or 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	67.57 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Time from Diagnosis to Trial Enrollment	8.5 Months n=5 Participants
Serum CA 19-9 Level at the Time of Enrollment	133 Units/ml n=5 Participants

PRIMARY outcome

Timeframe: Cycle 1 (4 weeks), for up to 6 cycles

Outcome measures

Outcome measures
Measure	18 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h n=6 Participants All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h n=2 Participants All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h n=1 Participants All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Number of Participants With Dose Limiting Toxicity (DLT )	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Cycle 1 (4 weeks), for up to 6 cycles

The MTD is the highest dose that induces dose limiting toxicity (DLT) in no more than 2 patients among a cohort of 6 patients. If 1 or fewer patients experience dose limiting toxicity than the dose level will define the MTD. Only DLT's that occurred during cycle 1 of each dose level were used to determine the MTD.

Outcome measures

Outcome measures
Measure	18 mg/m(2)/24h n=6 Participants All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
MTD (Maximum Tolerated Dose)	115 mg/ml/24h	—	—	—	—

SECONDARY outcome

Timeframe: Every 2 cycles (8 weeks), up to 18 weeks

Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	18 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h n=6 Participants All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h n=2 Participants All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h n=1 Participants All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial response (PR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Stable disease	4 Participants	4 Participants	2 Participants	2 Participants	0 Participants
Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease (PD)	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Every 2 cycles (8 weeks), up to 18 weeks

Population: Data was collected for this outcome measure but not analyzed because PET scans were inconsistently obtained. There was lack of scans pre-onstudy or while patient was on treatment. Without being able to make a pre-versus-on treatment comparison, this outcome measure was not done.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 2 cycles (8 weeks), up to 18 weeks

Population: This outcome measure was not done. No MRI data were collected. All patients had contrast-enhanced computed tomography (CTs,) and thus were followed for consistency reasons with CT and not MRI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 2 cycles (8 weeks), up to 18 weeks

Outcome measures

Outcome measures
Measure	18 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h n=6 Participants All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h n=2 Participants All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h n=1 Participants All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1) Complete response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1) Partial response (PR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1) Progressive disease (PD)	0 Participants	4 Participants	2 Participants	2 Participants	0 Participants
Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1) Stable disease (SD)	4 Participants	2 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From first day of treatment to the day of progression, assessed up to 221 months

Time to progression is the time between the first day of treatment to the day of disease progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	18 mg/m(2)/24h n=6 Participants All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Median Time to Progression	2 Months Interval 1.0 to 221.0	—	—	—	—

SECONDARY outcome

Timeframe: Overall survival was assessed through study completion, an average of 3 years.

Overall survival is defined as the time between the first day of treatment to the day of death.

Outcome measures

Outcome measures
Measure	18 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h n=6 Participants All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h n=2 Participants All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h n=1 Participants All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Median Overall Survival (OS)	NA Months No deaths.	9 Months Interval 3.0 to 15.0	9 Months Interval 3.0 to 16.0	15 Months Interval 0.0 to 15.0	NA Months No deaths.

SECONDARY outcome

Timeframe: 4 months

Resectability is defined by the MD Anderson Resectability criteria: Resectable is no extension; normal fat plane between the tumor and the artery (superior mesenteric artery (SMA)). No extension (celiac axis/hepatic artery). Patent (superior mesenteric vein/portal vein (SMV/PV)). Borderline resectable is tumor abutment ≤180◦ (one half or less) of the circumference of the artery; periarterial stranding and tumor points of contact forming a convexity against the vessel improve chances of resection (SMA). Short-segment encasement/abutment of the common hepatic artery (typically at the gastroduodenal origin) (celiac axis/hepatic artery). Short-segment occlusion with suitable vessel above and below (SMV/PV). Locally advanced is encased (\>180◦) (SMA). Encased and no technical option for reconstruction usually because of extension to the celiac axis/splenic/left gastric junction or the celiac origin (celiac axis/hepatic artery). Occluded and no technical option for reconstruction (SMV/PV).

Outcome measures

Outcome measures
Measure	18 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h n=6 Participants All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h n=2 Participants All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h n=1 Participants All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Number of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 2.5 years

Population: Data was not collected and this outcome measure was not done due to an insufficient number of participants enrolled in this study.

Number of selection criteria that can be used for unresectable pancreatic cancer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 2 years and 2 months and 21 days

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned

Outcome measures

Outcome measures
Measure	18 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h n=6 Participants All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h n=4 Participants All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h n=2 Participants All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h n=1 Participants All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Number of Participants With Serious and Non-Serious Adverse Events	4 Participants	5 Participants	3 Participants	2 Participants	1 Participants

Adverse Events

18 mg/m(2)/24h

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

36 mg/m(2)/24h

Serious events: 1 serious events

Other events: 5 other events

Deaths: 2 deaths

72 mg/m(2)/24h

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

96 mg/m(2)/24h.

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

115 mg/m(2)/24h

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	18 mg/m(2)/24h n=4 participants at risk All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h n=6 participants at risk All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h n=4 participants at risk All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h. n=2 participants at risk All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h n=1 participants at risk All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Infections and infestations Abdominal infection	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Investigations Alanine aminotransferase increased	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Blood and lymphatic system disorders Anemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Investigations Blood bilirubin increased	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Psychiatric disorders Depression	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
General disorders Fatigue	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Gastrointestinal disorders Gastroparesis	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.

Other adverse events

Other adverse events
Measure	18 mg/m(2)/24h n=4 participants at risk All participants that received at least one dose of gemcitabine 18 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	36 mg/m(2)/24h n=6 participants at risk All participants that received at least one dose of gemcitabine 36 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	72 mg/m(2)/24h n=4 participants at risk All participants that received at least one dose of gemcitabine 72 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	96 mg/m(2)/24h. n=2 participants at risk All participants that received at least one dose of gemcitabine 96 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.	115 mg/m(2)/24h n=1 participants at risk All participants that received at least one dose of gemcitabine 115 mg/m(2)/24h. gemcitabine dose escalation Gemcitabine: Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Investigations Alanine aminotransferase increased	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Investigations Alkaline phosphatase increased	50.0% 2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	66.7% 4/6 • Number of events 4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Blood and lymphatic system disorders Anemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Metabolism and nutrition disorders Anorexia	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Investigations Blood bilirubin increased	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
General disorders Chills	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Nervous system disorders Dizziness	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
General disorders Edema limbs	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
General disorders Fatigue	50.0% 2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
General disorders Fever	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Psychiatric disorders Hallucinations	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Investigations Lymphocyte count decreased	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	33.3% 2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	100.0% 1/1 • Number of events 3 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Gastrointestinal disorders Nausea	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Investigations Neutrophil count decreased	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	16.7% 1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
General disorders Pain	25.0% 1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/2 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.
Surgical and medical procedures Surgical and medical procedures - Other, retained foreign body	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/6 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/4 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.	0.00% 0/1 • Date treatment consent signed to date off study, approximately years, 2 months and 21 days.

Additional Information

Dr. Udo Rudloff

National Cancer Institute

Phone: 301-496-3098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place