Ovarian Cancer Clinical Trial

Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

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.

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Full 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.

View Eligibility Criteria

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 is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

139

Study ID:

NCT02900651

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 15 Locations for this study

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University of California San Francisco
San Francisco California, 94115, United States
UCLA Santa Monica Hematology / Oncology
Santa Monica California, 90404, United States
University of Texas MD Anderson Cancer Center Dept of Onc
Houston Texas, 77030, United States
Novartis Investigative Site
Toronto Ontario, M5G 2, Canada
Novartis Investigative Site
Shanghai Shanghai, 20003, China
Novartis Investigative Site
Chengdu Sichuan, 61004, China
Novartis Investigative Site
Villejuif Cedex Île-de-France, 94800, France
Novartis Investigative Site
Freiburg , 79106, Germany
Novartis Investigative Site
Koeln , 50937, Germany
Novartis Investigative Site
Hong Kong , , Hong Kong
Novartis Investigative Site
Milano MI, 20133, Italy
Novartis Investigative Site
Rozzano MI, 20089, Italy
Novartis Investigative Site
Fukuoka-city Fukuoka, 811-1, Japan
Novartis Investigative Site
Sunto Gun Shizuoka, 411 8, Japan
Novartis Investigative Site
Singapore , 16961, Singapore
Novartis Investigative Site
Madrid , 28041, Spain

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

139

Study ID:

NCT02900651

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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