Trial record 1 of 1 for:    BTCT4465A
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A Safety and Pharmacokinetic Study of BTCT4465A in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02500407
First received: July 14, 2015
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This study is designed to evaluate the safety and pharmacokinetics of BTCT4465A when administered as a single agent by intravenous (IV) infusion to participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Condition Intervention Phase
Lymphocytic Leukemia, Chronic, Lymphoma, Non Hodgkin
Drug: BTCT4465A
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BTCT4465A in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: During Cycle 1 (up to 21 days) ]
  • Incidence of adverse events [ Time Frame: From Cycle 1 Day 1 until 90 days after the last infusion (up to approximately 9 months) ]
  • Area under the concentration-time curve (AUC) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
  • Maximum serum concentration (Cmax) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
  • Minimum serum concentration (Cmin) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
  • Clearance (CL) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]
  • Volume of distribution at steady state (Vss) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]

Secondary Outcome Measures:
  • Incidence of objective tumor response [ Time Frame: At Screening and every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 3 years) ]
  • Duration of objective tumor response [ Time Frame: At Screening and every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 3 years) ]
  • Progression-free survival (PFS) [ Time Frame: At Screening and every 3 months until disease progression, start of new anti-cancer therapy, or withdrawal (up to approximately 3 years) ]
  • Incidence of anti-therapeutic antibodies (ATAs) to BTCT4465A [ Time Frame: Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ]

Estimated Enrollment: 170
Study Start Date: September 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation
Participants will receive BTCT4465A via IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles. Dose escalation will be guided by the observed incidence of DLTs at each dose level.
Drug: BTCT4465A
Participants with B-cell NHL and CLL will receive BTCT4465A via IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles.
Experimental: Dose Expansion
Participants will receive BTCT4465A at the recommended Phase 2 dose based on findings during dose escalation. BTCT4465A will be administered in 21-day cycles until disease progression or unacceptable toxicity for a maximum of 8 cycles.
Drug: BTCT4465A
Participants with B-cell NHL and CLL will receive BTCT4465A via IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults at least 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy at least 12 weeks
  • Dose-escalation stage: Grade 1 to 3b follicular lymphoma (FL), marginal zone lymphoma (MZL), transformed FL, Richter's transformation, diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), or CLL
  • Dose-expansion stage: DLBCL, transformed FL, Grade 1 to 3a FL, MZL, or CLL
  • Adverse events from prior anti-cancer therapy resolved to Grade 1 or better
  • Adequate hepatic, hematologic, and renal function
  • For participants and partners of childbearing potential, agreement to remain abstinent or utilize effective contraception

Exclusion Criteria:

  • Pregnant or lactating women
  • Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, radiotherapy, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug
  • Systemic immunotherapy within 12 weeks or 5 half-lives of drug prior to study drug
  • Systemic immunosuppressive medication within 2 weeks prior to study drug
  • Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation
  • Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia
  • History of confirmed progressive multifocal leukoencephalopathy (PML)
  • History of central nervous system (CNS) lymphoma or other CNS disease
  • Significant cardiovascular or pulmonary disease
  • Current infection, or prior infection requiring IV antibiotics and/or hospitalization within 4 weeks prior to study drug
  • Major surgery within 4 weeks prior to study drug
  • Hepatitis B or C or human immunodeficiency virus (HIV)
  • Receipt of a live attenuated vaccine within 4 weeks prior to study drug
  • History of drug or alcohol abuse within 12 weeks prior to Screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02500407

Contacts
Contact: Reference Study ID Number: GO29781 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
Duarte, California, United States, 91010
Not yet recruiting
La Jolla, California, United States, 92037
United States, Connecticut
Recruiting
New Haven, Connecticut, United States, 06510
United States, Missouri
Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Recruiting
New York, New York, United States, 10065
United States, Pennsylvania
Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Not yet recruiting
Houston, Texas, United States, 77030
Australia, Victoria
Not yet recruiting
Melbourne, Victoria, Australia, 3000
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada, V5Z 1H3
Canada, Ontario
Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Not yet recruiting
Montréal, Quebec, Canada, H3T 1E2
Korea, Republic of
Recruiting
Seoul, Korea, Republic of, 03080
Recruiting
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02500407     History of Changes
Other Study ID Numbers: GO29781 
Study First Received: July 14, 2015
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Lymphoma
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on January 23, 2017