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A Phase 1, Multi-Center, Open-Label, Dose Escalation Study of I-131-CLR1404 in Subjects With Relapsed or Refractory Advanced Solid Malignancies

Phase 1
18 Years
Open (Enrolling)

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Trial Information

A Phase 1, Multi-Center, Open-Label, Dose Escalation Study of I-131-CLR1404 in Subjects With Relapsed or Refractory Advanced Solid Malignancies

Inclusion Criteria:

- Relapsed or refractory advanced solid malignancy or choice not to pursue standard
treatment. Tumor types allowed: non-small cell lung, triple negative breast, soft
tissue sarcoma, colorectal, gastric, esophageal, prostate, ovarian cancer

- At least one lesion that qualifies as a "target lesion" based on RECIST 1.1

- Ambulatory with ECOG performance status of 0 to 2 and an estimated life expectancy of
at least 4 months

- 18 years of age or older

- Judged by Investigator to have initiative and means to be compliant with protocol and
within geographical proximity to make required study visits

- Ability to read, understand and provide written informed consent for initiation of
any study related procedures (subject or legal representative)

- Brain metastasis are acceptable if clinical condition has been stable for at least 1
month. Subjects with brain metastasis who require steroids must have been on a stable
or tapering dose of corticosteroids for at least 1 month prior to enrollment

- Negative serum pregnancy test within 24 hours of enrollment (Female subjects of
childbearing potential)

- Agreement to use an effective method of contraception (oral contraceptives,
double-barrier methods such as condom and diaphragm, intrauterine device, Norplant,
Depo-Provera) during the study and for 90 days following last dose of study drug

Exclusion Criteria:

- Subject or physician plans concomitant chemotherapy, therapeutic radiation and/or
biological treatment for cancer including immunotherapy while on study. Localized
palliative radiation therapy for bone pain is allowed during study period if
clinically indicated. Ongoing hormonal therapy may be continued

- Received more than three previous cytotoxic chemotherapy regimens

- Received more than 25% of total bone marrow irradiated, total body or hemi-body
irradiation or prior radioisotope therapy (except for benign thyroid disease)

- Diffuse lung disease or interstitial spread of carcinoma

- Prior radiation therapy or chemotherapy within 4 weeks of start of study

- Extradural tumor in contact with spinal cord or tumor located where swelling in
response to therapy may impinge upon spinal cord

- Another active medical condition(s) or organ disease(s) that may compromise subject
safety or interfere with safety and/or outcome evaluation of study drug

- Laboratory abnormalities, including but not limited to: WBC < 3000/uL, Absolute
neutrophil count < 1500/uL, Platelets < 150,000/uL, Hemoglobin ≤ 9.0 gm/dL, Total
bilirubin > 1.5 x upper limit of normal for age, SGOT or SGPT > 3 x upper limit of
normal for age if no liver metastases or > 5 x upper limit of normal for age in the
presence of liver metastases, Serum creatinine > 1.5 x upper limit of normal for age,
INR ≥ 2.0, 2+ proteinuria or casts indicative of intrinsic renal disease

- Treatment with investigational drug, investigational biologic, or investigational
therapeutic device within 28 days of initiating study treatment

- Received severely marrow toxic drugs (e.g. nitrosoureas, mitomycin)

- Received blood transfusions or hematopoietic growth factor therapy within 30 days of
study start

- Received prior stem cell transplantation

- Clinically significant cardiac co-morbidities including congestive heart failure (New
York Heart Association class III-IV heart disease), left ventricular ejection
fraction < 40%, unstable angina pectoris, serious cardiac arrhythmia requiring
medication or pacemaker, myocardial infarction within past 6 months

- Concurrent or recent (within 1 month) use of thrombolytic agents, or full-dose
anticoagulants (except to maintain patency of preexisting, permanent indwelling IV
catheters). Therapy with low-molecular weight heparin is acceptable as long as INR <

- Uncontrolled hypertension as defined by systolic blood pressure > 150 mm/Hg,
diastolic blood pressure > 100 mm/Hg or uncontrolled diabetes that would compromise
subject safety or interfere with safety and/or outcome evaluation of study drug

- Grade II-IV peripheral vascular disease or peripheral vascular surgery within past

- Major surgery within 4 weeks of enrollment

- Poor venous access and unable to receive study drug into a peripheral venous catheter

- Significant traumatic injury within past 4 weeks

- Ongoing or active infection requiring antibiotics or with fever >38.1º C (>101º F)
within 3 days of first scheduled day of dosing

- Receiving concurrent hemodialysis or peritoneal dialysis

- Known positive for HIV, Hepatitis C (active, previously treated or both), or is
Hepatitis B core antigen positive

- Pregnant or lactating

- Hospitalized

Type of Study:


Study Design:

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

Outcome Measure:

Determination of the recommended dose of I-131-CLR1404 in treating subjects with relapsed or refractory advanced solid malignancies

Outcome Description:

Largest administered dose with at most a 20% dose limiting toxicity rate

Outcome Time Frame:

Until non-tolerated dose is defined; dose escalation descision made upon review of data from a complete cohort (56 days after all subjects in cohort have received therapy infusion)

Safety Issue:


Principal Investigator

Glen Liu, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

December 2014

Related Keywords:

  • Cancer
  • refractory
  • relapsed
  • non-small cell lung cancer
  • triple-negative breast cancer
  • soft tissue sarcoma
  • colorectal cancer
  • esophageal cancer
  • prostate cancer
  • ovarian cancer



University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
City of Hope National Medical Center Los Angeles, California  91010
Georgetown University Hospital Washington, District of Columbia  20007