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BRIEF TITLE: Study of Albumin-bound Rapamycin Nanoparticles (Nab-rapamycin, ABI-009) in the Treatment of BCG Refractory or Recurrent Nonmuscle Invasive Transitional Cell Bladder Cancer

A Combined Phase 1 and Phase 2 Study of Albumin-bound Rapamycin Nanoparticles (Nab-rapamycin, ABI-009) in the Treatment of BCG Refractory or Recurrent Nonmuscle Invasive Transitional Cell Bladder Cancer


  • Org Study ID: BC001
  • Secondary ID: 1R42CA171552-01
  • NCT ID: NCT02009332
  • NCT Alias:
  • Sponsor: Aadi, LLC - Industry
  • Source: Aadi, LLC

Brief Summary

Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer

Overal Status Start Date Phase Study Type
Recruiting Start Date: April 2014 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Primary Outcome 1 - Time Frame: End of Study [EOS, 3 months] and follow-up [1 year]

Condition:

  • Non-muscle Invasive Bladder Cancer (NMIBC)

Eligibility

Criteria:
Inclusion Criteria:

1. Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary
bladder confirmed at the study institution. The patient must have demonstrated
nonmuscle-invasive recurrent bladder cancer refractory or recurrent to standard
intravesical therapy. Patients must exhibit disease recurrence after receiving
adequate intravesical BCG (at least 6 weeks induction plus 3 additional doses of
either induction or maintenance). Patients with a history of other intravesical agents
in addition to standard BCG will also be allowed to enroll. All grossly visible
disease must be fully resected and pathologic stage will be confirmed at the
institution where the patient is enrolled. This will include stage Ta, T1, Tis and
exclude all patients with muscle invasion (T2).

1. For phase 1, patients with multifocal low-grade Ta histology will be eligible for
participation

2. For phase 2, individuals with Ta disease only must have documentation of
high-grade histology

2. Age >18 and must be able to read, understand, and sign informed consent

3. Performance Status: ECOG 0, 1, and 2 (See Appendix III)

4. Hematologic inclusion within 2 weeks of start of treatment

1. Absolute neutrophil count >1,500/mm3

2. Hemoglobin >9.0 g/dl

3. Platelet count >100,000/mm3

5. Hepatic inclusion within 2 weeks of entry

1. Total bilirubin must be within normal limits.

2. Adequate renal function with serum creatinine ≤2.5 mg/dL

3. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN for the
institution, alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone
metastasis is present in the absence of liver metastasis

6. Women of childbearing potential must have a negative pregnancy test.

7. All patients of childbearing potential must be willing to consent to using effective
contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms
while on treatment and for 3 months after their participation in the study ends.

Exclusion Criteria:

1. Any other malignancy diagnosed within 1 year of study entry (except basal or squamous
cell skin cancers or noninvasive cancer of the cervix) is excluded

2. Concurrent treatment with any chemotherapeutic agent

3. Women who are pregnant or lactating

4. History of vesicoureteral reflux or an indwelling urinary stent

5. Participation in any other research protocol involving administration of an
investigational agent within 1 month prior to study entry

6. History of radiation to the pelvis

7. History of interstitial lung disease and/or pneumonitis

8. Evidence of metastatic disease
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: James McKiernan, MD

Role: Principal Investigator

Affiliation: Columbia University

Locations

Facility Status Contact
Columbia University Medical Center
New York, New York 10032
United States
Recruiting Ifeanyi Onyeji

ico2106@cumc.columbia.edu
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Recruiting Pamela Steele, RN BSN CCRC
615-343-2120
pamela.steele@vanderbilt.edu