A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT02453087
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DCDS0780A — DRUG
    Participants will receive escalating doses of DCDS0780A as intravenous infusion.
  • Rituximab — DRUG
    Participants will receive rituximab at a dose of 375 mg/m\^2 of body surface area as intravenous infusion.
  • Obinutuzumab — DRUG
    Participants will receive obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion.

Study Details

This open-label, multicenter, Phase 1/1b study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of DCDS0780A in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma. In the combination portion of the study, the safety and tolerability of DCDS0780A in combination with rituximab or obinutuzumab will be assessed.

Key Dates

Start date
Aug 4, 2015
Status verified
Aug 2019
Primary completion
Jul 12, 2019
Completion
Jul 12, 2019

Study Design

Enrollment
66 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DCDS0780A Monotherapy
    Participants will receive escalating doses of DCDS0780A as intravenous infusion as monotherapy on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).
  • Experimental: DCDS0780A + Rituximab
    Participants will receive escalating doses of DCDS0780A on Day 2 of Cycles 1 and 2, and from Cycle 3 onwards on Day 1 of each 21-day cycle in combination with rituximab at a dose of 375 milligrams per square meter (mg/m\^2) of body surface area as intravenous infusion on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).
  • Experimental: DCDS0780A + Obinutuzumab
    Participants will receive escalating doses of DCDS0780A on Day 2 of Cycles 1 and 2, and from Cycle 3 onwards on Day 1 of each 21-day cycle in combination with obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion on Days 1, 8, and 15 of Cycle 1, and from Cycle 2 onwards on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: Baseline up to 30 days after the last dose of study drug (up to 1 year) ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Stanford Cancer CenterStanfordCalifornia94305-5820-
Medical Center of Aurora; Rocky Mountain Cancer CentersAuroraColorado80012-
Georgetown University Medical Center Lombardi Cancer CenterWashington D.C.District of Columbia20007-
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)SarasotaFlorida34232-
New York University Cancer CenNew YorkNew York10016-
Willamette Valley Cancer Ctr - 520 Country ClubEugeneOregon97401-8122-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAStanford Cancer Center· Stanford, CAMedical Center of Aurora; Rocky Mountain Cancer Centers· Aurora, COGeorgetown University Medical Center Lombardi Cancer Center· Washington D.C., DCFlorida Cancer Specialists - Sarasota (North Catttlemen Rd)· Sarasota, FLNew York University Cancer Cen· New York, NY

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