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


Condition: Non-muscle Invasive Bladder Cancer (NMIBC)

Intervention:

  • Drug: ABI-009

Purpose: 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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02009332

Sponsor: Aadi, LLC

Primary Outcome Measures:

  • Measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
  • Time Frame: End of Study [EOS, 3 months] and follow-up [1 year]
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Number of Participants achieving a complete response as a Measure of Efficacy
  • Time Frame: End of Study [EOS, 3 months] and follow-up [1 year]
  • Safety Issue:

Estimated Enrollment: 40

Study Start Date: April 9, 2014

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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 bladder cancer refractory or recurrent to standard intravesical therapy. Refractory disease is defined as failure to achieve tumor-free status by 6 months of initiation of adequate BCG therapy. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months of initiation of adequate BCG therapy. Adequate BCG therapy includes at least 6 weeks induction plus 3 additional doses of either induction or maintenance. Patients with a history of other intravesical agents (except nab-rapamycin or gemcitabine) 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).
  2. For phase 1, patients with multifocal low-grade Ta histology will be eligible for participation
  3. For phase 2, individuals with Ta disease only must have documentation of high-grade histology
  4. For phase 2, prior intravesical treatment with nab-rapamycin or gemcitabine is not allowed
  5. Age >18 and must be able to read, understand, and sign informed consent
  6. Performance Status: ECOG 0, 1, and 2 (See Appendix III)
  7. Hematologic inclusion within 2 weeks of start of treatment
  8. Absolute neutrophil count >1,500/mm3
  9. Hemoglobin >9.0 g/dl
  10. Platelet count >100,000/mm3
  11. Hepatic inclusion within 2 weeks of entry
  12. Total bilirubin must be within normal limits.
  13. Adequate renal function with serum creatinine ≤2.5 mg/dL
  14. 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
  15. Women of childbearing potential must have a negative pregnancy test.
  16. 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

Locations:

  • Columbia University Medical Center
  • New York New York 10032 United States
  • Vanderbilt University Medical Center
  • Nashville Tennessee 37232 United States

View trial on ClinicalTrials.gov


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