Akt Inhibitor MK2206 in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT01481129 | Completed Phase 2 Results DMC FDA Drug

• 6 other identifiers: NCI-2012-00081LEONB-ET-2011-0412011-001970-25CDR0000716384ET-2011-0419022
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 9

Brief Summary

This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate According to the International Response Criteria for DLBCL (Cheson 2007)

  Rate of CR + PR according to Cheson 2007 after 4 months of treatment

  Up to 4 months

Secondary Outcomes (4)

• Duration of Response

  up to 4 years

• Overall Survival

  From the date of inclusion to the date of death from any cause, assessed up to 4 years

• Progression-free Survival (PFS)

  From the date of inclusion to the date of first documented disease progression, relapse or death from any cause, assessed up to 4 years

• Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  Up to 30 days

Study Arms (1)

Treatment (Akt inhibitor MK2206)

EXPERIMENTAL

Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Akt Inhibitor MK2206; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

Interventions

Akt Inhibitor MK2206 DRUG

Given PO

Also known as: MK2206

Treatment (Akt inhibitor MK2206)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (Akt inhibitor MK2206)

Pharmacological Study OTHER

Correlative studies

Treatment (Akt inhibitor MK2206)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diffuse large B-cell lymphoma
• Relapsed or refractory disease
• Measurable disease
• At least one measurable lymph node mass that is \> 1.5 cm in two perpendicular dimensions and that has not been previously irradiated or has grown since previous irradiation
• Dominant lymph node masses include up to 6 nodal masses that are clearly measurable in 2 perpendicular dimensions and \> 1.5 cm in each dimension
• Measurement may be by radiographic imaging
• If there are lymph node masses in the mediastinum or pelvis larger than 1.5 cm in 2 perpendicular dimensions, they should always be chosen as dominant masses
• The dominant masses should be from as disparate regions of the body as possible
• Measurable sites of disease are also extra-nodal sites such as splenic nodules and hepatic nodules that are thought to contain lymphoma, and are greater than 1 cm in the longest transverse dimension
• 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
• Salvage treatment, mobilization chemotherapy, high-dose chemotherapy, and planned post-transplant therapy should be considered as one regimen
• Relapsed or refractory patients who are candidates for high-dose chemotherapy and autologous or allogeneic stem cell transplantation are not eligible
• Tumor tissue sample must be available for pathological review

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

Hopitaux de Paris

Vellefaux, Paris, 75010, France

Location

Institut Bergonie Cancer Center

Bordeaux, 33076, France

Location

Henri Mondor University-Hospital Center

Créteil, 94000, France

Location

Hospital Claude Huriez Chru

Lille, 59037, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69310, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

MK 2206

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr Hervé Ghesquieres
• Organization: Centre Léon Bérard (now CHLS)

herve.ghesquieres@chu-lyon.fr

0426556824

Study Officials

• Herve Ghesquieres

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: November 29, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: September 28, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-08

Locations

FR (9)