Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

a study on Lymphoma

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Pamela Munster

Description

Summary

The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.

Official Title

A Phase I/II, Multicenter, Open-label Study of MAK683 in Adult Patients With Advanced Malignancies

Details

The purpose phase I of this trial is to characterize safety and tolerability and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of MAK683.

The purpose of the phase II of this trial will be to evaluate the anti-tumor activity of MAK683.

Keywords

Diffuse Large B-cell Lymphoma MAK683, DLBCL, EED - Embryonic ectoderm development, EZH2 - Enhancer of zeste homolog 2 Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse MAK683

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Eastern Cooperative Oncology Group (ECOG): 0 to 2
  2. Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)
  3. Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma,castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by RECIST 1.1.

You CAN'T join if...

  1. Other malignant diseases than the ones being treated in this study
  2. Severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result.
  3. B-cell lymphoma patients who have received prior allogeneic stem cell transplant
  4. Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
  5. Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control.
  6. Patient having out of range laboratory values defined as:

1) Insufficient bone marrow function at screening:

  • Platelets ≤ 50,000/mm3
  • Hemoglobin (Hgb) ≤ 80 g/L
  • Absolute neutrophil count (ANC) ≤ 1000/mm3 2) Insufficient hepatic and renal function at screening:
  • ALP, ALT, and AST > 3 x ULN (>5 x ULN if subject has liver metastases)
  • Total bilirubin >1.5 x ULN
  • Serum creatinine > 1.5 x ULN and/or creatinine clearance ≤ 50 mL/min

Locations

  • Novartis Investigative Site accepting new patients
    San Francisco California 94115 United States
  • Novartis Investigative Site accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02900651
Phase
Phase 1/2
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
June 5, 2018