A Study of BNC105P Combined With Ibrutinib

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT03454165
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • BNC105P — COMBINATION_PRODUCT
    BNC105P is the phosphate ester of BNC105, a small molecule tubulin polymerization inhibitor.
  • Ibrutinib — COMBINATION_PRODUCT
    A novel BTK inhibitor.

Study Details

A Phase I Trial of BNC105P in combination with BTK inhibitor ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia(CLL). This study proposes that ibrutinib will have far greater efficacy when it is combined with drugs that kill the CLL cells in peripheral circulation, thereby preventing them from returning to the protective lymph node niche. The study will establish the maximum tolerated dose(MTD) of the combination of BNC105P with ibrutinib, characterize the pharmacodynamic effects of BNC105P alone and in combination with ibrutinib in CLL cells, and provide preliminary assessment of the efficacy of the combination in CLL. The study consists of a Screening Period with baseline tumor assessment before BNC105P administration, a Treatment Period with up to six 21-day cycles and Follow-up Period. Subjects will receive a total of six cycles of therapy unless treatment is discontinued

Key Dates

Start date
Mar 9, 2018
Status verified
Jan 2023
Primary completion
Jan 14, 2021
Completion
Jan 14, 2021

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Evaluate the MTD of BNC105P in combination with ibrutinib in patients with relapsed/refractory CLL. Treatment will be administered on an outpatient basis but will also be permitted inpatient. BNC105P will be administered as a single agent prior to initiation of ibrutinib. Beginning with cycle 2, ibrutinib will be administered concomitantly with BNC105P at a starting dose of 420 mg PO daily. Each cycle will last for 21 days. Provided no toxicities occur, each patient will be treated for 6 cycles.

Primary Outcome Measure

To establish the maximum tolerated dose and toxicity of BNC105P plus Ibrutinib [ Time Frame: Two years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-

Find similar trials in Lebanon, NH

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Dartmouth-Hitchcock Medical Center· Lebanon, NH

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