Biotech Values

[ariadndndough]

http://clinicaltrials.gov/ct2/show/NCT01449461?term=ap26113&rank=1

nice find bth. especially as you said cohort 4

here are the criteria




Criteria
Patients must meet all the criteria for the cohort for which their entry is proposed.

PART 1: Dose Escalation Phase:

1.Histologically confirmed advanced malignancies. All histologies except leukemia
2.Refractory to available therapies or for whom no standard or available curative treatments exist
3.Tumor tissue available for analysis.
PART 2: Expansion cohorts (4 additional cohorts):

1.Expansion cohort 1: Non-small cell lung cancer (NSCLC) patients whose tumors exhibit anaplastic lymphoma kinase (ALK) rearrangements and who have not been treated with previous ALK inhibitors.

?Histologically confirmed NSCLC
?Tumor tissue available for analysis
?ALK rearrangement by fluorescence in situ hybridization (FISH)
?No prior ALK inhibitor therapy.
2.Expansion cohort 2: NSCLC patients whose tumors exhibit ALK rearrangements and who are resistant to at least one (1) prior ALK inhibitor:

?Histologically confirmed NSCLC
?Tumor tissue available for analysis
?ALK rearrangement by FISH
?Resistant to at least one (1) prior ALK inhibitor.
3.Expansion cohort 3: NSCLC patients whose tumors exhibit epidermal growth factor receptor (EGFR) activating mutations and who are resistant to at least one (1) prior EGFR inhibitor:

?Histologically confirmed NSCLC
?Tumor tissue available for analysis;
?Activating mutation in EGFR including point mutation or activating deletion;
?Resistant to at least one (1) prior EGFR inhibitor.
4.Expansion cohort 4: Patients with any cancers with abnormalities in ALK or other targets against which AP26113 is active. Examples include, but are not limited to, anaplastic large cell lymphoma (ALCL), diffuse large-cell lymphoma (DLCL), inflammatory myofibroblastic tumors (IMT), and other cancers with
ALK abnormalities, or tumors with ROS fusions:

•Histologically confirmed lymphomas and other cancers except for leukemias
•Tumor tissue available for analysis.


doug