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A Phase 1 Dose Escalation and Pharmacodynamic Study of ARQ 761 (Beta-Lapachone) in Adult Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

A Phase 1 Dose Escalation and Pharmacodynamic Study of ARQ 761 (Beta-Lapachone) in Adult Patients With Advanced Solid Tumors

This is an open label, dose escalation study of ARQ 761 administered intravenously at a
starting dose of 195 mg/m2 IV once weekly. Depending on toxicities observed, up to seven
treatment cohorts will be enrolled with dose escalation occurring by doubling (first
escalation) and 40% increments thereafter. If dosing is tolerated at all levels and
pharmacokinetic data suggest continued escalation is warranted, additional dose levels will
be considered.

Pharmacokinetic assessments will be performed on days 1 and 15 of the first cycle. Safety
and tolerability of ARQ 761 will be assessed for the duration of study treatment. Evaluation
of potential anti-tumor activity of ARQ 761 will be performed at regular intervals while
patients remain on study.

Patients receiving doses of ARQ 761 may be escalated a maximum of two times to the next
consecutive cohorts.

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

4. Age ≥18 years

5. 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

To determine the recommended Phase 2 dose (RP2D) of ARQ 761 administered intravenously.

Outcome Time Frame:

Patients will receive an average of 4 cycles of ARQ 761 (corresponding with a treatment cycle of 16 weeks).

Safety Issue:


Principal Investigator

David E Gerber, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center


United States: Food and Drug Administration

Study ID:

Ph1 ARQ 761



Start Date:

December 2011

Completion Date:

November 2014

Related Keywords:

  • Solid Tumors
  • Metastatic
  • Unresectable
  • Recurrent advanced
  • Neoplasms



UT Southwestern Medical Center - Simmons Cancer Center Dallas, Texas  75390