Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer

NCT01731652 | Completed Phase 2

• 1 other identifier: TMX-101-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.

Conditions

Carcinoma in Situ; Non Muscle Invasive Bladder Cancer

Keywords

bladder cancer; carcinoma in situ; non muscle invasive bladder cancer

Outcome Measures

Primary Outcomes (1)

• To assess the activity of TMX-101, as determined by the number of patients who experience complete response (CR).

  5 to 7 weeks after the last TMX -101 instillation

Secondary Outcomes (1)

• Proportion of patients experiencing adverse events (AEs), including serious adverse events (SAEs) and AEs leading to discontinuation from the study.

  Patients will be followed through treatment and follow-up, for an expected total period of up to 13 weeks.

Study Arms (1)

TMX-101

EXPERIMENTAL

TMX-101 0.4% (200 mg in 50 ml) instilled in the bladder once weekly for 6 weeks

Drug: TMX-101

Interventions

TMX-101 DRUG

Also known as: Imiquimod

TMX-101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or female patient is aged ≥18 years.
• Pathologically-proven, recurrent, primary, secondary or concomitant carcinoma in situ disease, defined by having either Ta or T1 with CIS, or CIS alone. In cases with T1 tumor lesions, muscularis propria tissue should be in the resected specimen to confirm that it is tumor-free.
• Patient has undergone mapping of the bladder between Days -28 and -14, with at least one biopsy providing pathological confirmation of CIS of the bladder. Slides must be available for a central pathology review.
• Patient has undergone bladder washing for cytology between Days -28 and -1. In patients in whom Ta or T1 lesion(s) were resected, the bladder washing must have occurred after the resection. Slides must be available for a central cytology review.
• Patient has an ECOG performance status 0-2.
• Patient has adequate bone marrow, hepatic, and renal function within 4 weeks before Day 0.
• Patient has read and understood the informed consent form and is willing and able to give informed consent.
• Patient fully understands the requirements of the study and is willing to comply with all study visits and assessments.
• If a woman of childbearing potential (WCBP), patient has a negative blood pregnancy test at the Screening visit. For the purposes of this study, WCBP is defined as a post-pubescent female, unless post-menopausal for at least 2 years, surgically sterile, or sexually inactive.
• If patient is a WCPB or male patient with a female partner of childbearing potential, must be willing to avoid pregnancy by using an adequate method of contraception from 2 weeks before through 4 weeks after the last study drug treatment. Adequate contraception is defined as follows: 2 barrier methods or 1 barrier method with a spermicide or intrauterine device.

You may not qualify if:

• Patient has evidence of muscle-invasive disease (i.e., T2 or higher)
• In the Investigator's opinion, patient is not able to hold instillation for at least 1 hour.
• In the Investigator's opinion, patient cannot tolerate intravesical administration or intravesical surgical manipulation.
• Patient has received radiation therapy of pelvis within 12 months before the first study drug treatment.
• Patient requires perioperative intravesical chemotherapy.
• Patient has a history of malignancy of the upper urinary tract.
• Patient has bone marrow impairment as evidenced by:
• Hemoglobin \<9.0 g/dL
• Absolute neutrophil count (ANC) \<1.5×109/L
• Platelet count \<120×109/L.
• Patient has renal impairment, as evidenced by:
• Serum creatinine \>2× the upper limit of normal (ULN), and/or
• Calculated creatinine clearance \<40 mL/min.
• Patient has liver function abnormality, as evidenced by:
• Total bilirubin \>1.5×ULN, or

Sponsors & Collaborators

• Telormedix SA: lead

Study Sites (4)

BCG Oncology

Phoenix, Arizona, 85032, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Urologic Consultants of SE PA

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Related Publications (1)

• Donin NM, Chamie K, Lenis AT, Pantuck AJ, Reddy M, Kivlin D, Holldack J, Pozzi R, Hakim G, Karsh LI, Lamm DL, Belkoff LH, Belldegrun AS, Holden S, Shore N. A phase 2 study of TMX-101, intravesical imiquimod, for the treatment of carcinoma in situ bladder cancer. Urol Oncol. 2017 Feb;35(2):39.e1-39.e7. doi: 10.1016/j.urolonc.2016.09.006. Epub 2016 Oct 26.

  PMID: 28341495 DERIVED

MeSH Terms

Conditions

Carcinoma in Situ; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 22, 2012
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

US (4)