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Chronic Lymphocytic LeukemiaPhase 1/2NCT01369849

Akt Inhibitor MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 1/2 study testing Akt Inhibitor MK2206, Bendamustine Hydrochloride and Laboratory Biomarker Analysis in people with Chronic Lymphocytic Leukemia and Recurrent Small Lymphocytic Lymphoma, run by National Cancer Institute (NCI) at 44 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This phase I/II trial studies the side effects and best dose of v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor MK2206 when given together with bendamustine hydrochloride and rituximab and to see how well they work in treating patients with refractory chronic lymphocytic leukemia or small lymphocytic… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Akt Inhibitor MK2206, Bendamustine Hydrochloride and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
44 sitesUnited States
Study dates
Sep 2011to Feb 2014
Phase
Phase 1/2
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

  • Diagnosis of chronic lymphocytic leukemia (CLL) according to the National Cancer Institute (NCI) criteria or small lymphocytic lymphoma (SLL) according to the World Health Organization (WHO) criteria; this includes previous documentation of:
  • Biopsy-proven SLL or
  • Diagnosis of CLL according to NCI working group criteria as evidenced by all of the following:
  • Peripheral blood B-cell count of > 5 x 10^9/L consisting of small to moderate size lymphocytes
  • Immunophenotyping consistent with CLL defined as:
  • The predominant population of lymphocytes share both B-cell antigens (CD19, CD20 [typically dim expression], or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3,CD2, etc.)
Show all 38Show fewer
  • Clonality as evidenced by kappa (Κ) or lambda (λ) light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g., immunoglobulin heavy chain variable [IGHV] analysis)
  • NOTE: splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
  • Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescence in situ hybridization (FISH) analysis for t (11;14) (IgH/CCND1) on peripheral blood or tissue biopsy, or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy
  • Demonstrated progression after one or two prior lines of CLL therapy; note: rituximab monotherapy does not count as a prior line of therapy
  • Progressive disease with any one of the following characteristics based on standard criteria for treatment as defined by the NCI-Working Group (WG) 1996
  • Symptomatic CLL characterized by any one of the following:
  • Weight loss >= 10% within the previous 6 months
  • Extreme fatigue attributed to CLL
  • Fevers > 100.5° Fahrenheit (F) for 2 weeks without evidence of infection
  • Drenching night sweats without evidence of infection
  • Evidence of progressive bone marrow failure with hemoglobin < 11 g/dL or platelet count < 100 x 10^9/L
  • Massive or rapidly progressive splenomegaly (> 6 cm below left costal margin)
  • Massive (> 10 cm) or rapidly progressive lymphadenopathy
  • Life expectancy >= 12 months
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless due to Gilbert's disease; if total bilirubin is > 1.5 x ULN, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert's to be diagnosed
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 ULN
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 times ULN
  • Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x ULN
  • A non-transfused platelet count >= 30 x 10^9/L
  • Neutrophil count (absolute neutrophil count [ANC]) >= 1 x 10^9/L
  • Hemoglobin (Hgb) >= 8 g/dL
  • Note: cytopenias due to bone marrow failure are common in patients with relapsed CLL requiring treatment; accordingly, normal bone marrow function is NOT required for participation
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Ability to complete patient diaries and questionnaire(s) by themselves or with assistance
  • Provide informed written consent
  • Willing to return to North Central Cancer Treatment Group (NCCTG) enrolling institution for follow-up
  • Willing to provide blood samples for correlative research purposes
  • Willing to provide bone marrow aspirate (body fluid) for correlative research purposes
  • MAYO ROCHESTER ONLY: willing to provide bone marrow core biopsy tissue for correlative research purposes
  • Willing to provide bone marrow biopsy for central pathology review (all patients)
  • Able to swallow whole tablets; NOTE: nasogastric or gastrostomy (G) tube administration is not allowed; tablets must not be crushed or chewed

Who cannot join

  • Prior treatment with bendamustine
  • Prior treatment with any experimental Akt inhibitors
  • More than 2 previous purine nucleoside based-therapy (i.e. fludarabine, pentostatin, or cladribine)
  • More than 2 previous alkylating agent based-therapy (i.e. cyclophosphamide, chlorambucil)
  • More than 3 total prior lines of therapy for CLL
  • Primary refractory disease as defined by progression while receiving or within 6 months of completion of a chemoimmunotherapy regimen such as fludarabine, cyclophosphamide and rituximab (FCR) or pentostatin, cyclophosphamide and rituximab (PCR)
Show all 60Show fewer
  • PHASE II ONLY: FISH abnormality of 17P deletions; (note: patients with 17P deletions will be included in Phase I but will be excluded in Phase II unless enough activity is found in the Phase I)
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens; including but not limited to the following:
  • New York Heart Association class III or IV heart disease
  • Recent myocardial infarction (< 1 month)
  • Uncontrolled infection
  • Known infection with the human immunodeficiency virus (HIV/acquired immune deficiency syndrome [AIDS]) and/or patients taking highly active antiretroviral therapy (HAART) as further severe immunosuppression with this regimen may occur
  • Infection with known chronic, active hepatitis C
  • Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded
  • Uncontrolled diabetes defined as hemoglobin A1c (HbA1c) >= 8 or fasting blood glucose >= 140 mg/dL
  • Any of the following:
  • History of significant ventricular arrhythmia in the last 5 years including: ventricular tachycardia or ventricular fibrillation
  • Corrected QT (QTc) prolongation on baseline electrocardiogram (ECG) (defined as a QTc interval > 450 msec for males and QTc interval > 470 msec for females)
  • Currently using a medication known to cause prolonged QTc which cannot be discontinued; note: other medications with possible risk of prolonged QTc are allowed but should be used with caution; patients using these medications should be monitored accordingly
  • Ventricular arrhythmia on baseline ECG (ventricular tachycardia or ventricular fibrillation >= 3 beats in a row)
  • Second or third degree heart block
  • Receiving any other investigational agent concurrently which would be considered as a treatment for the primary neoplasm
  • Other active primary malignancy requiring treatment or which limits survival to < 24 months
  • Any major surgery =< 28 days prior to registration
  • Any radiation therapy =< 4 weeks prior to registration
  • Current use of corticosteroids; EXCEPTION: low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical conditions; NOTE: previous use of corticosteroids is allowed
  • Active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; NOTE: patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation
  • Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450 3A4 (CYP450 3A4); use of the following strong or moderate inhibitors are prohibited =< 7 days prior to registration:
  • Strong inhibitors of CYP3A4
  • Indinavir
  • Nelfinavir
  • Ritonavir
  • Clarithromycin
  • Itraconazole
  • Ketoconazole
  • Nefazodone
  • Saquinavir
  • Telithromycin
  • Moderate inhibitors of CYP3A4
  • Aprepitant
  • Erythromycin
  • Fluconazole
  • Grapefruit juice
  • Verapamil
  • Diltiazem
  • Receiving any medications or substances that are inducers of CYP450 3A4; use of the following inducers is prohibited =< 12 days prior to registration
  • Inducers of CYP3A4
  • Efavirenz
  • Nevirapine
  • Carbamazepine
  • Modafinil
  • Phenobarbital
  • Phenytoin
  • Pioglitazone
  • Rifabutin
  • Rifampin
  • St. John's wort

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus CCOP

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Metro-Minnesota NCI Community Oncology Research Program

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Genesis HealthCare System

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Phase I/II Study of the Combination of Bendamustine, Rituximab and MK-2206 in the Treatment of Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

This phase I/II trial studies the side effects and best dose of v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor MK2206 when given together with bendamustine hydrochloride and rituximab and to see how well they work in treating patients with refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Akt inhibitor MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving Akt inhibitor MK2206 with bendamustine hydrochloride and rituximab may be an effective treatment for relapsed chronic lymphocytic leukemia or small lymphocytic lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety and maximum tolerated dose (MTD) of MK-2206 (Akt inhibitor MK2206) in combination therapy with bendamustine (bendamustine hydrochloride)-rituximab in relapsed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients. (Phase I) II. To assess the rate of complete response (CR) of MK-2206 in combination with bendamustine-rituximab in relapsed CLL or SLL patients. (Phase II)

SECONDARY OBJECTIVES:

  1. To assess clinical efficacy of MK-2206 in combination with bendamustine-rituximab as demonstrated by analysis of overall response rate (CR, complete response with incomplete bone marrow recovery [CRi], clinical complete response [CCR], near partial response [nPR] and partial response [PR]), duration of response, and treatment free survival.

II. To assess the toxicity profile of MK-2206 in combination with bendamustine-rituximab.

TERTIARY OBJECTIVES:

  1. Evaluation of whether the established CLL prognostic factors (cluster of differentiation [CD]38, CD49d, immunoglobulin heavy chain variable [IGHV], fluorescence in situ hybridization [FISH] and zeta-chain-associated protein kinase 70 [ZAP-70]) predict responses to the combination therapy of MK2206, with bendamustine-rituximab.

II. Minimal residual disease will be evaluated after treatment in patients who achieve a clinical response; minimal residual disease (MRD) status will be explored in relation to both the quality and duration of response.

III. Evaluation of the effects of the addition of MK-2206 to bendamustine-rituximab on B cell receptor initiated, phosphoinositide 3-kinase (PI3K)/Akt downstream signal pathways, apoptosis analysis and leukemic cell activation status, as well as multiple cytokine profiles and key gene expression analysis with focus on leukemic cells.

IV. Evaluation of marrow stromal cells (MSC)-CLL biology including the effects of the addition of MK-2206 to bendamustine-rituximab on CLL marrow stromal cell (MSC) proliferation, migration and cytokine production, as well as the adhesion capacity between MSC and leukemic cells.

OUTLINE: This is a phase I, dose-escalation study of Akt inhibitor MK2206 followed by a phase II study.

Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29 of course 1); rituximab intravenously (IV) on day 1 (day 8 of course 1); and bendamustine hydrochloride IV over 30-60 minutes on days 1-2 (days 8-9 of course 1). Treatment repeats every 28 days (35 days for course 1 and 84 days for course 6) for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 or 12 months for 3 years.

Being tested
Akt Inhibitor MK2206, Bendamustine Hydrochloride, Laboratory Biomarker Analysis, Rituximab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

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

  • Bendamustine HydrochlorideDrug

    Also called Bendamustin Hydrochloride, Cytostasan Hydrochloride, Ribomustin, SyB L-0501

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • RituximabBiological

    Also called BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, IDEC-102

    Given IV

Study groups in NCT01369849
Study groupRoleWhat they receive
Treatment (Akt inhibitor MK2206, bendamustine, rituximab)ExperimentalPatients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29 of course 1); rituximab IV on day 1 (day 8 of course 1); and bendamustine hydrochloride IV over 30-60 minutes on days 1-2 (days 8-9 of course 1). Treatment repeats every 28 days (35 days for course 1 and 84 days for course 6) for 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Akt Inhibitor MK2206; Drug: Bendamustine Hydrochloride; Other: Laboratory Biomarker Analysis; Biological: Rituximab

What is being measured

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

  1. Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)

    The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.The number of patients reporting a dose-limiting event are reported.

    Measured: Up to 35 days

  2. Proportion of Complete Response Defined to be a CR or CRi Noted as the Objective Status (Phase II)

    A Complete Response (CR) is defined by the NCI Working Group criteria and requires all of the following for a period of at least 2 months:

    • Absence of lymphadenopathy (e.g. lymph nodes >1.5 cm) by physical examination.
    • No hepatomegaly or splenomegaly by physical examination.
    • Absence of constitutional symptoms.
    • Neutrophils ≥1500/ul.
    • Platelets >100,000/ul (untransfused).
    • Hemoglobin >11.0 gm/dl (untransfused)
    • Peripheral blood lymphocytes <4000/uL

    Patients who fulfill all criteria for a CR but who have a persistent anemia, thrombocytopenia, or neutropenia related to drug toxicity rather than residual CLL will be classified as CR with incomplete marrow recovery (CRi).

    The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

    Measured: From registration to response, up to 84 days

Secondary outcomes (7)

  1. Biomarker Analysis (IgVH Gene Mutation)

    IgVH gene mutationwill be evaluated pre-treatment. This factors will be summarized and used to help characterize the types of patients accrued to this trial.

    Measured: Baseline

  2. Biomarker Analysis (CD38, CD49d, and ZAP-70)

    CD38, CD49d, and ZAP-70 status will be evaluated pre-treatment. These factors will be summarized and used to help characterize the types of patients accrued to this trial.

    Measured: Baseline

  3. Fluorescent in Situ Hybridization (FISH) Biomarker Analysis

    Fluorescent in situ hybridization (FISH) is a molecular cytogenetic technique that uses fluorescent probes that bind to only those parts of the chromosome with a high degree of sequence complementarity. It was developed by biomedical researchers in the early 1980s and is used to detect and localize the presence or absence of specific DNA sequences on chromosomes. In this disease group, there are recognized patterns of DNA sequences that play a role in prognostic outcomes. Patterns named 11q-, 13q-, Trisomy 12 may lead to different responses to treatments. Here we report the number of patients with each FISH prognosis evaluated pre-treatment. These factors will be summarized and used to help characterize the types of patients accrued to this trial.

    Measured: Baseline

  4. Duration of Response

    Duration of response is defined for all evaluable patients who have achieved a clinical response as the date at which the patient's objective status is first noted to be a CR, CRi, CCR, nPR, or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

    Measured: Median follow-up of 39 months and maximum follow-up of 54 months

  5. Minimal-residual Disease

    Minimal residual disease (MRD) will be evaluated after treatment in patients who achieve a complete clinical response. Flow cytometry will be used to detect approximately 1 CLL cell per 10,000 leukocytes following induction. A score of positive means CLL cells were found and a negative score means no CLL cells were found. The number of patients with an MRD negative score are reported here.

    Measured: Cycle 6 assessment (maximum of 231 days post-registration)

  6. Overall Response Rate

    The Overall response rate is estimated by the total number of complete or partial responses (CR, CRi, CCR, nPR, or PR) divided by the total number of evaluate patients. Complete and partial responses were scored using the NCI Working Group criteria. A Complete Response (CR, CRi, and CCR) is characterized by an absence of lymphadenopathy, heptomegaly and splenomegaly with or without normalized blood counts and bone marrow assessment . A PR is defined as having >50% decrease in lymphocyte count and reduction in sum of the products of measured nodes and an improvement in blood counts. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.

    Measured: 3 months post-treatment

  7. Treatment-free Survival

    Treatment free survival is defined to be the time from registration to the date of initation of subsequent therapy or death. The distribution of treatment free survival will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to the date of initiation of subsequent therapy or death, median follow-up time is 37 months

Timeline

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

  1. First posted9 Jun 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionFeb 2014
  4. Study completionFeb 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01369849
Sponsor's protocol ID
NCI-2011-02675
Other IDs
NCI-2011-02675, CDR0000701372, NCCTG-N1087, N1087, N1087, U10CA180821, U10CA025224
Status last verified
Aug 2017
First submitted
8 Jun 2011
Last updated
15 Sep 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Akt Inhibitor MK2206, Bendamustine Hydrochloride and Laboratory Biomarker Analysis in people with Chronic Lymphocytic Leukemia and Recurrent Small Lymphocytic Lymphoma, run by National Cancer Institute (NCI) at 44 sites in United States.

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 38 inclusion and 60 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 15 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 44 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 28 Jun 2016). 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?

Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) (time frame: Up to 35 days). The study lists 2 primary outcomes in all. 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 NCT01369849.

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 15 Sep 2017.

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