Study of MK 2206 in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma
NCT ID: NCT01466868
Last Updated: 2014-07-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
22 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-11-30
Study Completion Date
2014-06-30
Brief Summary
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The purpose of this study is to evaluate the antitumor efficacy and the safety of MK 2206 in patients with relapsed or refractory diffuse large B cell lymphoma.
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Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL)
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Detailed Description
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Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent subtype of Non-Hodgkin lymphoma (NHL) around the world, in all age groups.
DLBCL is a curable disease and combination of monoclonal antibody against CD20 (rituximab) with cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) regimen have improved the prognosis of patients with a 20% increase of the cure rate. For the remaining patients who are not in complete response and/or who relapse after first line therapy, the possibility of cure is dramatically reduced.
As PI3K/AKT/mTOR pathway regulates the expression of cyclin D1, c-Myc and Stat3 proteins, which are involved in the pathogenesis of DLBCL HL), this signalling axis is an emerging therapeutic target for treatment of DLBCL.
One study has shown that the level of p-Akt is an adverse prognostic feature in DLBCL and is found in 52% of tumors samples from DLBCL patients.
Given the fact that AKT is overactivated in about to 52% of DLBCL and is considered as a poor prognosis factor, we postulate that targeting AKT in DLBCL may be an interesting therapeutic strategy.
MK-2206 is an orally selective allosteric inhibitor of AKT developed by MERCK currently highlighted as a promising therapeutic option for cancer patients and under clinical development in several Phase 1 trials.
Therefore, we propose to conduct a Phase II study using a two-stage Simon's design with objective response rate (ORR) as the primary endpoint.
DLBCL is a curable disease and combination of monoclonal antibody against CD20 (rituximab) with cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) regimen have improved the prognosis of patients with a 20% increase of the cure rate. For the remaining patients who are not in complete response and/or who relapse after first line therapy, the possibility of cure is dramatically reduced.
As PI3K/AKT/mTOR pathway regulates the expression of cyclin D1, c-Myc and Stat3 proteins, which are involved in the pathogenesis of DLBCL HL), this signalling axis is an emerging therapeutic target for treatment of DLBCL.
One study has shown that the level of p-Akt is an adverse prognostic feature in DLBCL and is found in 52% of tumors samples from DLBCL patients.
Given the fact that AKT is overactivated in about to 52% of DLBCL and is considered as a poor prognosis factor, we postulate that targeting AKT in DLBCL may be an interesting therapeutic strategy.
MK-2206 is an orally selective allosteric inhibitor of AKT developed by MERCK currently highlighted as a promising therapeutic option for cancer patients and under clinical development in several Phase 1 trials.
Therefore, we propose to conduct a Phase II study using a two-stage Simon's design with objective response rate (ORR) as the primary endpoint.
Conditions
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Diffuse Large B Cell Lymphoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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MK2206
Treatment is started the day after registration (day 1)until progression according to Cheson international response criteria or documented toxicity.
Group Type
EXPERIMENTAL
MK2206
Intervention Type
DRUG
Treatment will be administered orally once weekly, 2 hours before or after a meal, at day 1, 8, 15, 22 over a 28 day cycle period.
The starting dose level is 200 mg. 2 dose reduction are allowed (135 mg and 90 mg)in case of documented toxicity according to the specific algorithms.
Interventions
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MK2206
Treatment will be administered orally once weekly, 2 hours before or after a meal, at day 1, 8, 15, 22 over a 28 day cycle period.
The starting dose level is 200 mg. 2 dose reduction are allowed (135 mg and 90 mg)in case of documented toxicity according to the specific algorithms.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Patients with histologically confirmed diffuse large B-Cell lymphomas.
* Patients must have measurable disease.
* Subjects must have received at least two prior treatment lines.There is no maximal limit on the number of prior therapies
* Prior treatment must include CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) -like chemotherapy in combination with rituximab. Rituximab used alone is not considered as a separate regimen.
* Prior treatment could include high dose chemotherapy with autologous stem-cell transplantation if patients had progressed ≥ 3 months after this treatment.
* Salvage treatment, mobilization chemotherapy, high-dose chemotherapy and planned post-transplant therapy should be considered as one regimen
* Relapsed or refractory patients who are candidate to high-dose chemotherapy and autologous or allogenic stem cell transplantation are not eligible.
* Patients must have discontinued all prior therapies for at least 5 times the t1/2 of prior anti-cancer therapies before study entry.
* Male or female patients, age ≥ 18 years.
* Life expectancy greater than 4 months.
* ECOG performance status ≤2.
* Patients must have normal organ and marrow function as defined below:
* Absolute neutrophil count ≥ 1.5 x 109/L,
* Platelet count ≥ 100 x 109/L or ≥75 x 109/L if the bone marrow is involved,
* AST/ALT ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis) direct bilirubin ≤ 1.5ULN
* Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 50mL/min
* Patients must agree to use adequate double contraception
* Patients must be able to swallow whole tablets.
* Cardiovascular baseline QTcF≤ 450 msec (male) or QTcF≤470msec (female).
* Signed written informed consent document.
* Patients with French Social Security in compliance with the French law relating to biomedical research.
* Patients must have measurable disease.
* Subjects must have received at least two prior treatment lines.There is no maximal limit on the number of prior therapies
* Prior treatment must include CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) -like chemotherapy in combination with rituximab. Rituximab used alone is not considered as a separate regimen.
* Prior treatment could include high dose chemotherapy with autologous stem-cell transplantation if patients had progressed ≥ 3 months after this treatment.
* Salvage treatment, mobilization chemotherapy, high-dose chemotherapy and planned post-transplant therapy should be considered as one regimen
* Relapsed or refractory patients who are candidate to high-dose chemotherapy and autologous or allogenic stem cell transplantation are not eligible.
* Patients must have discontinued all prior therapies for at least 5 times the t1/2 of prior anti-cancer therapies before study entry.
* Male or female patients, age ≥ 18 years.
* Life expectancy greater than 4 months.
* ECOG performance status ≤2.
* Patients must have normal organ and marrow function as defined below:
* Absolute neutrophil count ≥ 1.5 x 109/L,
* Platelet count ≥ 100 x 109/L or ≥75 x 109/L if the bone marrow is involved,
* AST/ALT ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5.0 x ULN if liver metastasis) direct bilirubin ≤ 1.5ULN
* Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 50mL/min
* Patients must agree to use adequate double contraception
* Patients must be able to swallow whole tablets.
* Cardiovascular baseline QTcF≤ 450 msec (male) or QTcF≤470msec (female).
* Signed written informed consent document.
* Patients with French Social Security in compliance with the French law relating to biomedical research.
Exclusion Criteria
* Tumor tissue sample not available for pathological review.
* Patients with others than Diffuse large B-Cell Lymphoma histology.
* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
* Patients who have not recovered from adverse events grade \> 1 due to agents administered more than 4 weeks earlier.
* Patients who are receiving any other investigational agents.
* Patients with known CNS involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the compliance to the study protocol.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 tablets.
* Patients with uncontrolled hyperglycemia
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and breastfeeding women are excluded from this study.
* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MK-2206.
* Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption.
* Patients with clinically important history of liver disease, including viral or other hepatitis or cirrhosis.
* Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years.
* Uncontrolled hypertension with resting SBP\>140 or resting DBP\>90mm Hg
* Patients with others than Diffuse large B-Cell Lymphoma histology.
* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
* Patients who have not recovered from adverse events grade \> 1 due to agents administered more than 4 weeks earlier.
* Patients who are receiving any other investigational agents.
* Patients with known CNS involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the compliance to the study protocol.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 tablets.
* Patients with uncontrolled hyperglycemia
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and breastfeeding women are excluded from this study.
* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MK-2206.
* Patients with malabsorption syndrome or other condition that would interfere with intestinal absorption.
* Patients with clinically important history of liver disease, including viral or other hepatitis or cirrhosis.
* Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years.
* Uncontrolled hypertension with resting SBP\>140 or resting DBP\>90mm Hg
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Sponsor Role
collaborator
Centre Leon Berard
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hervé Ghesquières, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard, Lyon, France
Philippe Cassier, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Institut Bergonié
Bordeaux, , France
Site Status
Centre Henri Mondor
Créteil, , France
Site Status
CHRU
Lille, , France
Site Status
Centre Leon Berard
Lyon, , France
Site Status
Institut Paoli Calmettes
Marseille, , France
Site Status
CHU St Eloi
Montpellier, , France
Site Status
CHU
Nancy, , France
Site Status
CHU de Nantes
Nantes, , France
Site Status
Hôpital Saint-Louis
Paris, , France
Site Status
Hôpital Necker
Paris, , France
Site Status
Centre Hospitalier LYON SUD
Pierre-Bénite, , France
Site Status
Centre Henri Becquerel
Rouen, , France
Site Status
Institut Gustave Roussy
Villejuif, , France
Site Status
Countries
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France
References
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Reference Type
BACKGROUND
Other Identifiers
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AKTIL
Identifier Type: -
Identifier Source: org_study_id
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NCT07082686
RECRUITING
PHASE2
Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma
NCT05867030
WITHDRAWN
PHASE1
Outpatient Epcoritamab as 2L in NTE R/R DLBCL
NCT06811272
RECRUITING
PHASE2
A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas
NCT04464798
TERMINATED
PHASE1
A Study to Patients With Relapsed/Refractory Follicular Lymphoma Treated With Liso-cel (Lisocabtagene Maraleucel) in the Post Marketing Setting
NCT06794268
RECRUITING
Feasibility Study Of Adding Bortezomib to R-ICE Chemotherapy To Treat Relapsed/ Refractory Diffuse Large B-Cell Lymphoma
NCT01226849
COMPLETED
PHASE1
Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma
NCT02049541
COMPLETED
PHASE1
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
NCT02401048
COMPLETED
PHASE1/PHASE2
Refractory Diffuse Large B-cell Lymphoma
NCT03664336
COMPLETED
Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma
NCT02581878
COMPLETED
PHASE1
Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
NCT01197560
COMPLETED
PHASE2/PHASE3
Pembrolizumab for Patients With PD-L1 Diffuse Large B Cell Lymphoma (DLBCL)
NCT03990961
COMPLETED
PHASE2
Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma
NCT02266147
TERMINATED
PHASE1/PHASE2