Source: https://www.mycancergenome.org/content/clinical_trials/NCT02765165/
Timestamp: 2020-02-23 16:31:04
Document Index: 667514640

Matched Legal Cases: ['art 1', 'art 1', 'art 2', 'art 2', 'art 1', 'art 1', 'art 2', 'art 1', 'art 3', 'art 1', 'art 4', 'art 2']

Clinical Trial: NCT02765165 - My Cancer Genome
https://clinicaltrials.gov/show/NCT02765165
Brief Title: Phase 1/2 Study of USL311 Alone and in Combination With Lomustine in Subjects With Advanced Solid Tumors and Relapsed/Recurrent Glioblastoma Multiforme (GBM)
ORG STUDY ID: P311-201
NCT ID: NCT02765165
USL311 Dose-Escalation USL311, Solid Tumor, Part 1a
USL311 Dose-Escalation USL311, Solid Tumor, Part 1b
USL311 Dose-Escalation USL311 with Lomustine, Solid Tumor, Part 2
Lomustine Dose-Escalation USL311 with Lomustine, Solid Tumor, Part 2
Dose-Escalation USL311, Solid Tumor, Part 1a Experimental USL311, intravenous, once per week, starting at 60 mg/m˄2
Dose-Escalation USL311, Solid Tumor, Part 1b Experimental USL311, oral, daily, starting at 40 mg
Dose-Escalation USL311 with Lomustine, Solid Tumor, Part 2 Experimental USL311, oral, daily, starting at dose as determined in Part 1b, in combination with lomustine 90 mg/m˄2, oral, once every 6 weeks
Dose-Expansion, USL311, GBM, Part 3 Experimental USL311, oral, daily, starting at dose determined in Part 1b
Dose-Expansion, USL311 with Lomustine, GBM, Part 4 Experimental USL311, oral, daily, in combination with lomustine, oral, once every 6 weeks, at dose(s) as determined in part 2
4. Must have adequate bone marrow and renal/hepatic function within protocol specified
5. Disease-free period of > 2 years from any other previous malignancies, excluding
carcinoma in situ of the cervix. Subjects with prostate cancer Stage 1 that do not
require treatment may also be included
9. Must have available archived tumor tissue and willing and able to provide consent for
study access to such tissue
10. For subjects with a history of seizures, must be adequately controlled on a stable
regimen of anti-epileptic drugs
11. Histologically or cytologically documented diagnosis of solid tumor for which no
standard therapy is recognized or have failed or intolerant to the standard-of-care
14. Subjects with treated (surgically excised or irradiated) and stable brain metastases
are eligible as long as the subject has adequately recovered from treatment and the
treatment was ≥ 28 days prior to initiation of study drug(s) and baseline brain
computed tomography (CT) with contrast or magnetic resonance imaging (MRI) ≤ 14 days
of initiation of study drug is negative for new brain metastases
18. Subject is suitable for re-resection, per Investigator discretion, as a component of
their clinical care
1. Subjects who have had recent systemic anticancer therapies, interventional device
treatment and/or radiotherapy either within 14 days prior to first dose of study
drug(s) or have not recovered (to grade ≤ 1) from all clinically significant
toxicities related to prior therapies
2. Subjects who have had any major surgery (not including re-resection surgery required
in Phase 2) within 28 days prior to first dose of study drug(s), or minor surgery
within 14 days prior to first day of study drug(s)
3. Subjects taking any strong cytochrome P450 3A4 inducers within 14 days prior to the
first dose of study drug(s)
4. Subjects taking any strong cytochrome P450 3A4 inhibitors within 14 days prior to the
5. Subjects taking any agents with moderate to high risk to prolong QTc interval or to
cause Torsades de Pointes within 14 days prior to the first dose of study drug(s)
6. Subjects who have been treated with an investigational agent or investigational
interventional device within 21 days prior to the first dose of study drug(s)
7. Subject is growth factor dependent or transfusion dependent, or has received growth
factor support or transfusion support within 14 days prior to the first dose of study
17. Any active medical condition or previous major abdominal surgery or procedure that
might, in the investigator's opinion, have a significant effect on USL311 absorption
Measure: Phase 1: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Time Frame: Approximately 26 weeks
Description: USL311 as a single agent in subjects with advanced solid tumors and USL311 in combination with lomustine in subjects with advanced solid tumors
Measure: Phase 1 and Phase 2: Treatment-related adverse events as assessed by CTCAE v4.03
Time Frame: Approximately 26 or 52 weeks
Description: USL311 as a single agent and in combination with lomustine
Measure: Phase 1 and Phase 2: Progression free survival (PFS)
Measure: Phase 1 and Phase 2: Objective response rate (ORR%)
Measure: Phase 1 and Phase 2: Peak concentration (Cmax)
Description: USL311 in plasma and whole blood and lomustine in plasma
Measure: Phase 1 and Phase 2: Time to peak concentration (Tmax)
Measure: Phase 1 and Phase 2: Area under the concentration vs time curve (AUC)