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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02009332
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : December 10, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Non-muscle Invasive Bladder Cancer (NMIBC) Drug: ABI-009 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2014
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: ABI-009 Drug: ABI-009
Other Name: nab-rapamycin

Primary Outcome Measures :
  1. 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] ]

Secondary Outcome Measures :
  1. 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] ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02009332

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Aadi, LLC
National Cancer Institute (NCI)
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Principal Investigator: James McKiernan, MD Columbia University
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Responsible Party: Aadi, LLC Identifier: NCT02009332    
Other Study ID Numbers: BC001
1R42CA171552-01 ( U.S. NIH Grant/Contract )
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs