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ARQ 501 in Subjects With Cancer

A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00075933
Enrollment
80
Registered
2004-01-13
Start date
2003-09-30
Completion date
2007-01-31
Last updated
2009-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

ARQ 501, an investigational anticancer drug, is intended to selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints known to be defective in cancer using the Company's unique biology platform, Activated Checkpoint Therapy™ (ACT). ARQ 501 has the potential for improved activity and reduced toxicity over other molecular approaches and traditional cancer chemotherapy.

Interventions

Sponsors

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologically or cytologically confirmed solid tumor that is metastatic, unresectable or recurrent and for which standard curative or palliative measures do not exist or are no longer effective. * ECOG performance status greater than or equal to 1 * Life expectancy greater than three months * Acceptable pretreatment clinical laboratory results

Exclusion criteria

* Subjects who have had chemotherapy or radiotherapy within 4 weeks * Subjects receiving any other investigational agents * Subjects with known untreated brain metastases * Subjects receiving hepatic enzyme-inducing antiseizure drugs (EIASD) * Subjects with uncontrolled intercurrent illnesses * Pregnant women

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026