[c09aa8]: / templates / fillins / 558.txtFILLINS.csv

Download this file

# Blank 1 Frequency Blank 2 Frequency
1 1 for all parts the participant must be in the judgment of the investigator an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic 2 . 2
2 2 subjects must be refractory to or intolerant of existing 1 7th edition guidelines who have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit been intolerant to treatment or refused standard treatment . 2
3 3 relapse or intolerance all approved lines of therapy prior to enrollment unless they are not an appropriate candidate for a particmcLar approved therapy or no approved therapy exists . note there is no limit on the number of prior therapies that a patient subject may have received prior to enrollment in any cohort . 2b . eligibility canadian sites subjects with advanced or metastatic solid tumors that have disease progression after treatment with approved available therapies in site s country for the 1 therapy ies known to provide clinical benefit . 1
4 4 her2 expressing 1 type or for whom available therapies have limited benefit and the subject refuses the available therapy . includes subjects with locoregional disease that have relapsed / recurred within 6 months of chemo radiation or who have no standard of care or beneficial options . no limit on the number of prior treatments 1
5 5 her2 overexpressing 3 by ihc or her2 2 and fish positive gastric 1 as follows part 1 any locally advanced unresectable and / or metastatic her2 expressing her2 1 2 or 3 by ihc cancer that has progressed after receipt of all therapies known to confer clinical benefit 1
6 6 part i recurrent or progressive disease on prior standard therapies with known clinical benefit with the exception of adjuvant bladder 1 must have progressed after prior treatment with trastuzumab part 2 locally advanced unresectable and / or metastatic cancer that has progressed after receipt of all therapies know to confer clinical benefit unless ineligible to receive a specific therapy as follows 1
7 7 for the dose escalation portion of the trial patients with available therapies known to confer clinical benefit platinum sensitive ovarian 1 popmcLation 1
8 8 patients with available therapies known to confer clinical benefit platinum sensitive r nrecurrent ovarian 1 must be excluded 1
9 9 established therapy known to provide clinical benefit for their conditions or where subjects refuse existing therapies . for arm g subjects must have newly histologically or cytologically confirmed diagnosis of locally advanced cervical 1 must be excluded from the dose escalation portion 1
10 10 salivary gland 1 confined to the pelvis only . 1
11 11 1 and transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit have been intolerant to treatment 1
12 12 metastatic stage iv or recurrent nsclc according to american joint committee on 1 diagnosis . 1
13 13 stage iv mss crc according to american joint committee on 1 NA