Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

  • STATUS
    Recruiting
  • End date
    Aug 17, 2022
  • participants needed
    203
  • sponsor
    Novartis Pharmaceuticals
Updated on 5 August 2021
cancer
hodgkin's disease
measurable disease
b-cell lymphoma

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.

Description

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.

Details
Condition Diffuse Large B-Cell Lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma
Treatment MAK683
Clinical Study IdentifierNCT02900651
SponsorNovartis Pharmaceuticals
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

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
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
Clear my responses

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