Solid Tumors Clinical Trial
Official title:
A Phase 1 Dose Escalation and Pharmacodynamic Study of ARQ 761 (Beta-Lapachone) in Adult Patients With Advanced Solid Tumors
Verified date | March 2020 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary Objective:
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 761
administered intravenously.
Secondary Objectives:
To determine the pharmacokinetic profile of ARQ 761 To assess the preliminary anti-tumor
activity of aRQ 761
Status | Completed |
Enrollment | 91 |
Est. completion date | March 2019 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subjects must have a 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. 2. Prior and concurrent therapy: Chemotherapy: At least four weeks since prior cytotoxic chemotherapy or 6 weeks since nitrosoureas or mitomycin. Molecular targeted agents including monoclonal antibodies and tyrosine kinase inhibitors: At least two weeks since last therapy. Endocrine therapy: Subject may be remain on LHRH antagonist therapy for prostate cancer if tumor progression has been confirmed. Radiotherapy: At least 3 weeks since most recent radiotherapy. Other investigational therapy: At least four weeks since any other investigational therapy. Concurrent therapy: No other concurrent anticancer or investigational therapy permitted except as noted above. 3. Measurable disease is not required, but will be evaluated in each subject when possible. 4. Age =18 years 5. Eastern Cooperative Oncology Group (ECOG) performance status = 1 6. Life expectancy = three months. 7. Central venous access, such as a Portacath or Hickman Line. 8. Pretreatment clinical laboratory parameters within 14 days 9. Availability of 10 unstained slides or paraffin-embedded tissue block from archived tumor specimen. 10. Subjects must be recovered from any toxicity related to prior anti-neoplastic therapy (to grade <1). Patients with CTCAE grade 2 or less sensory neuropathy or any grade alopecia are eligible. Exclusion Criteria: 1. Subjects who have had cytotoxic chemotherapy or treatment with monoclonal antibodies within 4 weeks, radiotherapy within 3 weeks, or other molecular targeted therapies. 2. Subjects may not be receiving any other investigational agents. 3. Subjects with known untreated brain metastases. Subjects with known, treated brain metastases must be stable with no symptoms for four weeks. 4. Subjects receiving enzyme-inducing antiseizure drugs ("EIASD"). 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, 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. 6. Pregnant women and breastfeeding should be discontinued. 7. Absence of central venous access for administration of the study drug. |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center - Simmons Cancer Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | ArQule |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) | To determine the recommended Phase 2 dose (RP2D) of ARQ 761 administered intravenously. | Patients will receive an average of 4 cycles of ARQ 761 (corresponding with a treatment cycle of 16 weeks). | |
Secondary | Pharmacokinetic profile of ARQ761 | Serial venous blood samples will be drawn from each subject during first and fourth infusion of study drug to determine the plasma levels of ARQ761.If the same dose is not administered for the first and fourth infusion of study drug, Pharmacokinetics (PK) samples will only be collected after the first dose. PK samples to be collected at pre-infusion, 15min,30min, 55min (5 mins before end of infusion), 75 min, 2,4,6,h post infusion, 24h, 48h, and 168h | Samples will be drawn from each subject during first and fourth infusion of study drug |
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