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Metastatic Solid Tumors, Refractory/Relapsed Hematologic MalignanciesPhase 1NCT00825487

Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic Malignancies

A Phase 1 study testing ARQ 621 in people with Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 4 sites in United States.

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 is an open-label, dose escalation study of intravenous ARQ 621 administered to patients with late-stage solid tumors or hematologic malignancies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ARQ 621
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesUnited States
Study dates
Aug 2009to Sep 2011
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
  • A histologically or cytologically confirmed metastatic solid tumor or refractory/relapsed hematologic malignancy
  • Have a life expectancy of at least 12 weeks
  • ≥18 years of age
  • Measurable disease as defined by:
  • Solid Tumors: Response Evaluation Criteria in Solid Tumors
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  • Multiple Myeloma (MM): International Uniform Response Criteria, at least one of the following:
  • Monoclonal protein in the plasma of ≥0.5 g/dL
  • Monoclonal protein in the urine of ≥0.2 g/24 hr urine collection
  • Serum immunoglobulin free light chain (FLC) ≥100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kappa to lambda FLC ratio
  • Malignant Lymphoma (ML): International Working Group Response Criteria
  • At least one site of disease ≥2 cm in longest diameter (a lesion ≥1 cm can be considered if PET positive)
  • Chronic Lymphocytic Leukemia (CLL): NCI Working Group Guidelines
  • Lymphocytosis (5 x 10^9 /L) with B-cell marker (CD19, CD20,CD23) + CD5
  • High-risk characteristics (hemoglobin <10g/dL OR platelets <100 x 10^9 /L)
  • Acute Myelogenous Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL): only patients with bone marrow or peripheral blast count of ≥20%
  • Acute Promyelocytic Leukemia (APML): patients must be refractory to all-trans retinoic acid (ATRA) and arsenic trioxide
  • Chronic Myelogenous Leukemia (CML): patients in blast crisis (bone marrow or peripheral blast count ≥20%) may be included if refractory to prior therapy and to any therapy the investigators deems of higher priority (for example, BCR-ABL inhibitors such as imatinib mesylate [Gleevec], nilotinib [Tasigna], or dasatinib [Sprycel])
  • ECOG performance status ≤2
  • Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 621 dose
  • Females of childbearing potential must have a negative serum pregnancy test
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN) or ≤5.0 × ULN with metastatic liver disease
  • Hemoglobin (Hgb) ≥10 g/dL (except in cases considered related to hematologic malignancy)
  • Total bilirubin ≤1.5 × ULN
  • Creatinine ≤1.5 x ULN (≤2.0 x ULN in cases considered related to multiple myeloma)
  • Absolute neutrophil count ≥1.5 x 10^9/L (except in cases considered related to hematologic malignancy)
  • Platelets ≥100 x 10^9/L (except in cases considered related to hematologic malignancy)
  • Patients with hematologic malignancies who have progressed following at least two prior treatment regimens

Who cannot join

  • Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of the first dose
  • In cases of hematologic malignancies, 4-week recovery from prior anticancer treatment is not required, however the patient must recover from prior treatment-related non-hematological toxicities to grade 2 or less
  • When required for supportive care corticosteroids or hydroxyurea may be used
  • Surgery within four weeks prior to the first dose
  • Known untreated brain metastases or leptomeningeal disease
  • Patients with solid tumors who were treated for brain metastases and who have shown stable disease for at least 8 weeks prior to enrollment will be allowed
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  • Pregnant or breastfeeding
  • Uncontrolled concurrent illness including, but not limited to ongoing or active symptomatic infection requiring systemic therapy, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients having a history of Thrombotic thrombocytopenic purpura (TTP) or Hemolytic-uremic syndrome (HUS) or HUS spectrum will be excluded from the study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Study site

    Boston, Massachusetts, 02111

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Translational Genomics Institute

    Phoenix, Arizona, 85004

  • Premiere Oncology

    Santa Monica, California, 90404

Other trials in United States

About this study

Official title: A Phase 1 Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic Malignancies

This is an open-label, dose escalation study of intravenous ARQ 621 administered to patients with late-stage solid tumors or hematologic malignancies.

Read the detailed description

The study is designed to explore the safety, tolerability and pharmacokinetics of ARQ 621 and define a recommended phase 2 (RP2D)dose of ARQ 621.Treatment will be initiated at a dose level of 10 mg/m^2 IV infusion for an hour once weekly in 4-week (28 day) consecutive and continuous cycles. ARQ 621 should be infused IV over two hours at doses 200 mg/m^2 and higher (cohort 8 and above). All cycles of therapy will consist of the patient taking ARQ 621 intravenously once weekly for 4 weeks. Dose escalation will proceed initially by doubling (cohorts 2 and 3) and subsequently by a modified Fibonacci scheme. Dose escalations will be performed using 3-6 patient cohorts. In these cohorts, if a single dose limiting toxicity (DLT) is experienced among patients 1-3, the dose cohort will be expanded to six patients. The maximum tolerated dose (MTD) will be defined as the dose level at which no greater than 1/6 patients experiences a DLT. Once an MTD is identified, up to an additional 20 patients (with types of malignancy to be determined at a later date by study investigator and clarified by study amendment) may be treated at this MTD of ARQ 621. If an MTD is not identified in the initial 10 dosing cohorts, dose escalation will proceed in a manner to be defined by subsequent amendment with the purpose of determining a RP2D of ARQ 621.

Being tested
ARQ 621
Keywords
metastatic, hematologic, malignancy, multiple, myeloma, malignant, lymphoma, chronic, lymphocytic, leukemia, acute, myelogenous, promyelocytic, dose escalation, safety, tolerability, pharmacodynamics, tumor, PK
Medical subject headings
Hematologic Neoplasms, Neoplasm Metastasis, Neoplasms, Neoplasms, Plasma Cell, Lymphoma, Bronchiolitis Obliterans Syndrome, Leukemia

What participants receive

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

  • ARQ 621Drug

    Treatment will be initiated at a dose level of 10 mg/m^2 IV infusion for an hour once weekly in 4-week (28 day) consecutive and continuous cycles. ARQ 621 should be infused IV over two hours at doses 200 mg/m^2 and higher (cohort 8 and above).

Study groups in NCT00825487
Study groupRoleWhat they receive
ARQ 621 treatmentExperimentalNot described
Receives: Drug: ARQ 621

What is being measured

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

  1. To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 621 administered intravenously.

    Measured: 24 months estimated

Secondary outcomes (3)

  1. To determine the pharmacokinetic profile of ARQ 621.

    Measured: 24 months estimated

  2. To determine the pharmacodynamic profile (incl. biomarkers) of ARQ 621.

    Measured: 24 months estimated

  3. To assess the preliminary anti-tumor activity of ARQ 621.

    Measured: 24 months estimated

Timeline

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

  1. First posted21 Jan 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionMay 2011
  4. Study completionSep 2011

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00825487
Sponsor's protocol ID
ARQ 621-101
Status last verified
Oct 2011
First submitted
13 Jan 2009
Last updated
19 Oct 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ARQ 621 in people with Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 4 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 28 inclusion and 9 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 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 621 administered intravenously. (time frame: 24 months estimated). 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 NCT00825487.

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 19 Oct 2011.

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