Clinical trial NCT02519270: Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects
Official title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-Hodgkin Lymphoma
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: The Leukemia and Lymphoma Society
First posted: 2015-08-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with Refractory Non-Hodgkin Lymphoma (NHL)

Detailed description: This open-label, non-randomized, first-in-human Phase 1 study involves two stages:

In the Dose-Escalation Stage, ascending dose cohorts will be treated in 2 periods until the maximum tolerated dose is identified. In Period 1, subjects will receive 2 doses of IGN002 administered weekly. In Period 2, subjects will receive up to 24 additional doses of IGN002 administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.

In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the identified maximum tolerated dose administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.

Eligibility criteria: Inclusion Criteria:

* Documented history of immunohistochemistry (IHC)-confirmed CD20-positive (with no subsequent history of CD20-negativity) B-cell, NHL, including diffuse large B cell (DLBCL), mantle cell, marginal zone, lymphoplasmacytic, follicular, transformed follicular, or primary mediastinal B cell lymphoma
* Refractory disease, having failed available therapies
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Life expectancy \> 3 months
* Adequate organ function

Exclusion Criteria:

* Treatment with an approved or investigational chemotherapy drug within 28 days of Day 1
* Treatment with an approved or investigational anti-CD20 drug within 28 days of Day 1
* Treatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1
* Radiation therapy within 4 weeks of Day 1

Primary outcomes:
measure: To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL
timeFrame: Weekly for 6 months
Secondary outcomes:
measure: To characterize the pharmacokinetic (PK) profile of ascending doses of IGN002 administered weekly
timeFrame: Weekly for 6 months
measure: To assess the anti-tumor activity of IGN002 using the Lugano Classification for NHL
timeFrame: Every 8 weeks for 6 months, then at 1, 3 and 6 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA
state: California
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
References: