Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG): 0 to 2
  • Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)
  • 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.

Exclusion Criteria

  • Other malignant diseases than the ones being treated in this study
  • 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.
  • B-cell lymphoma patients who have received prior allogeneic stem cell transplant
  • Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
  • Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control.
  • 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 & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Novartis Pharmaceuticals Corporation

Trial IDs

Primary ID CMAK683X2101
Secondary IDs NCI-2017-00635, 2016-001860-12
Clinicaltrials.gov ID NCT02900651