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Diffuse Large B Cell LymphomaPhase 2NCT01481129

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

A Phase 2 study testing Akt Inhibitor MK2206, Laboratory Biomarker Analysis and Pharmacological Study in people with Diffuse Large B Cell Lymphoma, run by National Cancer Institute (NCI) at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
Akt Inhibitor MK2206, Laboratory Biomarker Analysis and Pharmacological Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
9 sitesFrance
Study dates
Dec 2011to Jun 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • No known CNS involvement
  • ECOG performance status < 2 (Karnofsky > 60%)
  • Life expectancy > 4 months
  • Absolute neutrophil count >= 1,500/µL
  • Platelets >= 100,000/µL (>= 75,000/µL if the bone marrow is involved)
  • Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) =< 2.5 X ULN
  • Calculated creatinine clearance >= 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Women of child-bearing potential and men must agree to use adequate contraception
  • Must be able to swallow whole tablets
  • Nasogastric or G-tube administration is not allowed
  • Tablets must not be crushed or chewed
  • Patients with French Social Security in compliance with the French law relating to biomedical research allowed
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK2206 tablets
  • Hyperglycemia should be well controlled on oral agents
  • Cardiovascular baseline QTcF =< 450 msec (male) or QTcF =< 470 msec (female)
  • No 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
  • No HIV-positive patients on combination antiretroviral therapy
  • No patients with malabsorption syndrome or other condition that would interfere with intestinal absorption
  • No patients with clinically important history of liver disease, including viral or other hepatitis or cirrhosis
  • No 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
  • Must have recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients must have discontinued all prior therapies for at least 5 times the half-life of all prior anticancer therapies before study entry
  • Prior treatment could include high-dose chemotherapy with autologous stem-cell transplantation if patients had progressed >= 3 months after this treatment
  • No chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
  • Patients must not be receiving any other investigational agents
  • No other investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy
  • No concurrent radiotherapy

Who cannot join

None listed.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • Institut Bergonie Cancer Center

    Bordeaux, 33076

  • Henri Mondor University-Hospital Center

    Créteil, 94000

  • Hospital Claude Huriez Chru

    Lille, 59037

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hopital Saint Louis

    Paris, 75010

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69310

  • Hopitaux de Paris

    Vellefaux, Paris, 75010

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase 2 Study of MK-2206 in Patients With Relapsed or Refractory Diffuse Large-B Cell Lymphoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the antitumor activity of Akt inhibitor MK2206 (MK2206) in terms of objective response rate (ORR) at 4 months (complete response [CR], and partial response [PR]) as per the 2007 International Cheson response criteria.

SECONDARY OBJECTIVES:

  1. To evaluate the antitumor activity of MK2206 in terms of ORR at 4 months (CR, unconfirmed complete response [CRu], and PR) as per the 1999 International Cheson response criteria.

II. To determine the duration of response, defined as the time from the date of the best response to the date of progression.

III. To determine the progression-free survival and overall survival of these patients.

IV. To determine the safety of MK2206. V. To identify predictive biomarkers for treatment outcome. (exploratory) VI. To conduct a pharmacodynamic study using FDG-PET scans. (exploratory)

OUTLINE: This a multicenter study.

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

After completion of study treatment, patients are followed up every 3 months.

Being tested
Akt Inhibitor MK2206, Laboratory Biomarker Analysis, Pharmacological Study
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Akt Inhibitor MK2206Drug

    Also called MK2206

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT01481129
Study groupRoleWhat they receive
Treatment (Akt inhibitor MK2206)ExperimentalPatients 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.
Receives: Drug: Akt Inhibitor MK2206; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 4 months

Secondary outcomes (4)

  1. Duration of Response

    Described in responding subjects using descriptive statistics (median, extreme values, etc.).

    Measured: up to 4 years

  2. Overall Survival

    Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.

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

  3. Progression-free Survival (PFS)

    Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.

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

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

    Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionJun 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01481129
Sponsor's protocol ID
NCI-2012-00081
Other IDs
NCI-2012-00081, LEONB-ET-2011-041, 2011-001970-25, CDR0000716384, ET-2011-041, 9022
Status last verified
Aug 2017
First submitted
24 Nov 2011
Last updated
28 Sep 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Akt Inhibitor MK2206, Laboratory Biomarker Analysis and Pharmacological Study in people with Diffuse Large B Cell Lymphoma, run by National Cancer Institute (NCI) at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate According to the International Response Criteria for DLBCL (Cheson 2007) (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01481129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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