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A Phase I/II, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR610 Given Weekly in Subjects With Solid Tumors

Phase 1/Phase 2
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I/II, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR610 Given Weekly in Subjects With Solid Tumors

Following informed consent, subjects undergo baseline evaluation and disease assessment.
PR610 is administered intravenously weekly.

In the absence of progressive disease or unacceptable toxicity, subjects may continue to
receive PR610. Intra-subject dose escalation (to no higher than the highest safe level) is
allowed in subjects who are not experiencing dose limiting toxicity. Disease assessment will
be repeated at week 6 and then every 8 weeks thereafter.

Pharmacokinetic (PK) assessment (PR610 and PR610E) will be performed in cycle one and two
for all subjects.

After determination of the MTD and the determination of the phase II dose, additional
subjects with NSCLC that is genetically resistant to reversible EGFR inhibitors will be
accrued into an expansion cohort.

Inclusion Criteria:

- Signed informed consent

- Age 18 years or more

- Histologically-confirmed, progressive, locally advanced or metastatic solid tumor

- Failed, refused, or not eligible for standard of care therapy

- ECOG performance status of 0, 1, or 2

- At least 30 days from prior anticancer therapy including chemotherapy, hormonal
(except for the control of prostate cancer which may be continued),
investigational, biological and irradiation

- No remaining grade 1 or higher toxicity from prior cancer therapies

- At least four (4) weeks from prior major surgery

- Women of child-bearing potential must be willing to use an acceptable contraceptive
method and must have a negative urine or serum pregnancy test within 2 weeks prior to
beginning treatment on this trial

- Sexually active men must be willing to use an acceptable contraceptive method

- Adequate hematological and biological function

- Willingness to participate in PK sampling during cycles 1 and 2

- Willingness to provide permission to access archived tumor samples for evaluation of
EGFR mutation status

- Willingness to provide samples for storage of normal tissue containing wild-type DNA

Additional Inclusion Criteria during Expansion Phase

- Stage IIIB to IV, non-squamous, non-small cell lung cancer (NSCLC) with known
sensitizing mutations in EGFR, and the T790M resistance mutation

- At least one target lesion as defined by RECIST 1.1 that allows for evaluation of
tumor response

Exclusion Criteria:

- Pregnant or nursing women

- Any uncontrolled medical illness including, but not limited to, significant
gastrointestinal disorders, cardiovascular disease, or interstitial lung disease

- History of clinically significant cardiovascular abnormalities, eg., uncontrolled
hypertension, CHF (NYHA classification ≥2), unstable angina, poorly controlled
arrhythmias, myocardial infarction within 6 months of study entry, implantable
pacemaker or implantable cardioverter defibrillator

- Clinically significant abnormal 12-lead ECG with QTcF >450 msec

- Use of any medications known to produce QT prolongation

- Family history of Long QT Syndrome

- Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or
equivalent) ≥400 mg/m2

- Cardiac left ventricular function with resting ejection fraction of less than 50%

- Symptomatic CNS lesions or known CNS lesions that require therapy

- Prior therapy with an irreversible EGFR inhibitor

- Prior history of an allergic reaction to a tyrosine kinase inhibitor

Additional Exclusion Criteria during Expansion Phase

- Any other malignancy likely to effect the assessment of toxicity or efficacy of PR610

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the Maximum Tolerated Dose (MTD) of PR610 as a Weekly IV Infusion

Outcome Description:

The first cohort of three subjects will receive PR610 at Dose Level 1. Subsequent cohorts will receive PR610 at a dose levels determined as per dose escalation criteria. The MTD will be defined as the dose level at which one (1) or fewer subject in six exhibit DLT with the next highest dose level demonstrating two (2) or more of six (6) subjects with DLT (or for which more than ≥33% of subjects exhibit DLT if the cohort size exceeds 6 subjects).

Outcome Time Frame:

3 weeks (1 cycle)

Safety Issue:


Principal Investigator

Proacta Inc.

Investigator Role:

Study Chair

Investigator Affiliation:

Proacta, Incorporated


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

December 2013

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • non-small cell lung cancer
  • non-squamous, non-small cell lung cancer
  • solid tumors
  • lung cancer
  • Neoplasms



Scottsdale HealthcareScottsdale, Arizona  85251
South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229
Robert H. Lurie Comprehensive Cancer Research CenterChicago, Illinois  60611