Clinical Trial of ARQ 761 in Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
ArQule
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01502800
First received: October 18, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: ARQ 761
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation and Pharmacodynamic Study of ARQ 761 (Beta-Lapachone) in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: Patients will receive an average of 4 cycles of ARQ 761 (corresponding with a treatment cycle of 16 weeks). ] [ Designated as safety issue: Yes ]
    To determine the recommended Phase 2 dose (RP2D) of ARQ 761 administered intravenously.


Secondary Outcome Measures:
  • Pharmacokinetic profile of ARQ761 [ Time Frame: Samples will be drawn from each subject during first and fourth infusion of study drug ] [ Designated as safety issue: Yes ]
    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, 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


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ARQ 761
    ARQ 761 will be 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
    Other Name: Beta-Lapachone
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502800

Contacts
Contact: David E Gerber, MD 214-648-4180 david.gerber@utsouthwestern.edu
Contact: Melana Lindsey, MHSA 2146487094 melana.Lindsey@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center - Simmons Cancer Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: David E Gerber, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
ArQule
Investigators
Principal Investigator: David E Gerber, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01502800     History of Changes
Other Study ID Numbers: Ph1 ARQ 761, NCI-2011-03317
Study First Received: October 18, 2011
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Metastatic
Unresectable
Recurrent advanced

Additional relevant MeSH terms:
Neoplasms
Beta-lapachone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on July 24, 2014