2023-07-12
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v18
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 97→confirmed 60
Study sitesdetails revised at 7 of 7 sites
Show 17 earlier versions
2023-06-29
minor
Study Status, Contacts/Locations v17
Primary completion date2023-08→2024-08
Completion date2023-08→2024-08
Study sites7 entries, revised
MemoralMemorial Sloan Kettering Basking Ridge
MemoralMemorial Sloan Kettering Monmouth
MemoralMemorial Sloan Kettering Westchester
2022-10-26
minor
Study Status v16
Re-verified, no change to tracked fields
2022-09-01
minor
Study Status v15
Primary completion date2022-08→2023-08
Completion date2022-08→2023-08
2022-02-02
minor
2 amendments v13-v14
2 re-verifications since 2021-07-13, no change to tracked fields
2021-04-29
minor
Study Status, Study Design, Arms and Interventions, Eligibility v12
Primary completion date2021-08→2022-08
Completion date2021-08→2022-08
Enrollment target57→97
Study arms1→4
Eligibility criteria+83 characters
[...] pain medication must be on a stable regimen at study entry
Any condition requiring systemicSystemic treatment with corticosteroids (> 10 mg daily prednisone eq [...] complete the entire study
Concomitant anticoagulation with oralcoumarin anticoagulantsagents (ege.g., warfarin), direct thrombin andinhibitors Factor(e.g., dabigatran), direct factor Xa inhibitors)inhibitor betrixaban, or platelet inhibitors (ege.g., clopidogrel).
Allowed anticoagulants are the following:
Lo [...] Low-dose low molecular weight heparins (LMWH) are permitted
Anticoagulation with therapeuticTherapeutic doses of LMWH isor anticoa [...] [...]
2021-01-14
minor
6 amendments v6-v11
6 re-verifications since 2019-07-01, no change to tracked fields
2019-06-21
minor
Study Status, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v5
Enrollment target37→57
Study sites8→7
Eligibility criteria+76 characters
[...] within 2 weeks prior to Cycle 1, Day 1)
Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
Alanine aminotransferase (ALT), aspartate aminotransferase [...] tase (ALP) ≤ 3 x upper limit of normal (ULN).
ALP ≤ 5 x ULN withif patient has documented bone metastases.
Serum bilirubin ≤ 1.5 x ULN .
Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled.
Serum albumin ≥ 2.8 g/dl
Patients with known Gilbert disease [...] bilirubin level ≤ 3 x ULN may be enrolled.
INR and aPTT ≤ 1.53 x ULN • within 14 days of first dose of study treatment.This appl [...] [...]
2019-05-01
minor
Study Status, Contacts/Locations v4
Study sitescontacts updated at 8 of 8 sites
2019-04-11
minor
Study Status, Contacts/Locations v3
Study sites8 entries, revised
Memorial Sloan Kettering Cancer CenterNassau
2019-02-27
minor
Study Status, Contacts/Locations v2
2018-10-10
minor
Study Status, Eligibility, Contacts/Locations v1
Eligibility criteria-32 characters
[...] m major surgery must have occurred 1 month before first dose, from biopsies at least 21 days, and from minor surgery (eg, simple excision, biopsy, tooth extraction) at least 10 days before first dose.
Subj [...] boplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 714 days before theof first dose of study treatment
Concomitant anticoagulation w [...]