CompletedPhase 1/2

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

United States21 participantsStarted 2014-04-09

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).
✓. For phase 1, patients with multifocal low-grade Ta histology will be eligible for participation
✓. For phase 2, individuals with Ta disease only must have documentation of high-grade histology
✓. For phase 2, prior intravesical treatment with nab-rapamycin or gemcitabine is not allowed
✓. Age \>18 and must be able to read, understand, and sign informed consent
✓. Performance Status: ECOG 0, 1, and 2 (See Appendix III)
✓. Hematologic inclusion within 2 weeks of start of treatment
✓. Absolute neutrophil count \>1,500/mm3

Exclusion criteria

✕. 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
✕. Concurrent treatment with any chemotherapeutic agent
✕. Women who are pregnant or lactating
✕. History of vesicoureteral reflux or an indwelling urinary stent
✕. Participation in any other research protocol involving administration of an investigational agent within 1 month prior to study entry
✕. History of radiation to the pelvis
✕. History of interstitial lung disease and/or pneumonitis
✕. Evidence of metastatic disease

What they're measuring

Phase 1: Dose Limiting Toxicities (DLT) Following Intravesical Administration of ABI-009

Timeframe: Duration of treatment (6 weeks) plus 30 days follow up (up to 2.5 months)

Phase 2: Number of Participants Achieving a Complete Response Following Intravesical Administration of ABI-009 and Gemcitabine

Timeframe: End of Study [EOS, 3 months]

Trial details

NCT IDNCT02009332

SponsorAadi Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-01

Results submitted2021-03-08

View on ClinicalTrials.gov More Non-muscle Invasive Bladder Cancer (NMIBC) trials