Clinical Trial of ARQ 761 in Advanced Solid Tumors

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: ArQule; ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
• Treatments: Beta-lapachone

Criteria

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.