Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

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

ClinicalTrials.gov Identifier: NCT02900651

Novartis Reference Number: CMAK683X2101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study 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.

Condition 
Diffuse Large B-cell Lymphoma
Phase 
Phase 1
Phase 2
Overall status 
Recruiting
Enrollment count 
203 participants
Start date 
Oct 03, 2016
Completion date 
Jan 25, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
MAK683
Drug: MAK683

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

Study Locations

United States
University of California San Francisco
Recruiting
San Francisco, 94115
California
United States
UCLA Santa Monica Hematology / Oncology
Recruiting
Santa Monica, 90404
California
United States
University of Texas MD Anderson Cancer Center Dept of Onc
Recruiting
Houston, 77030
Texas
United States
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 2M9
Ontario
Canada
France
Novartis Investigative Site
Recruiting
Villejuif Cedex, 94805
-
France
Germany
Novartis Investigative Site
Recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany
Hong Kong
Novartis Investigative Site
Recruiting
Hong Kong,
-
Hong Kong
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Novartis Investigative Site
Recruiting
Rozzano, 20089
MI
Italy
Japan
Novartis Investigative Site
Recruiting
Fukuoka-city, 811-1395
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Sunto Gun, 411 8777
Shizuoka
Japan
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Madrid, 28041
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]