Clinical Trials /

Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer

NCT02009332

Description:

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

Related Conditions:
  • Bladder Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: BC001
  • SECONDARY ID: 1R42CA171552-01
  • NCT ID: NCT02009332

Conditions

  • Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

DrugSynonymsArms
ABI-009nab-rapamycinABI-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

Trial Arms

NameTypeDescriptionInterventions
ABI-009Experimental
  • ABI-009

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 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).

               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

               3. For phase 2, prior intravesical treatment with nab-rapamycin or gemcitabine is
                  not allowed

          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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

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:
Description:

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:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aadi, LLC

Last Updated

July 18, 2017