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ARQ 621

Phase 1

Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Oct 19, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

ARQ 621 · 1 trial · 1 indication

Phase 1 1
NCT00825487Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic MalignanciesMetastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies
COMPLETED50 Analytics
PHASE1COMPLETED
Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic Malignancies
Metastatic Solid Tumors, Refractory/Relapsed Hematologic MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

To determine the pharmacokinetic profile of ARQ 621.
24 months estimated
To determine the pharmacodynamic profile (incl. biomarkers) of ARQ 621.
24 months estimated
To assess the preliminary anti-tumor activity of ARQ 621.
24 months estimated
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARQ 621 treatmentEXPERIMENTAL -

Interventions

NameTypeDescription
ARQ 621DRUGTreatment 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).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * 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 Insuran...

Countries:United States
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Frequently asked questions about ARQ 621

What is ARQ 621 used for?

ARQ 621 is an investigational small molecule being studied for the treatment of metastatic solid tumors and refractory or relapsed hematologic malignancies. It is in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in patients.

Who makes ARQ 621?

ARQ 621 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for oncology indications.

What phase is ARQ 621 in?

ARQ 621 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and potential efficacy in patients with metastatic solid tumors and hematologic malignancies.

What clinical trials is ARQ 621 in?

ARQ 621 has been studied in one completed clinical trial, identified as NCT00825487. This was a dose escalation study in adult patients with metastatic solid tumors and hematologic malignancies, conducted in the United States with a total enrollment of 50 participants.

Is ARQ 621 FDA approved?

ARQ 621 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed clinical trial, NCT00825487, was a dose escalation study, but the drug has not yet received regulatory approval for any indication.