Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Micronutrients

All Drugs and Chemicals

Hematinics

Antineoplastic Agents

Vitamins

Folic Acid

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

10-deazaaminopterin

Aminopterin

Trace Elements

Folic Acid Antagonists

Enzyme Inhibitors

Folinic Acid

Methylcobalamin

Folate

Vitamin B9

Vitamin B12

Cobalamin

Cyanocobalamin

Vitamin B12 : 1 mg intramuscular injection Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate.

Folic Acid: 1-1.25 mg orally Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30 days after last dose of pralatrexate.

Intravenous (IV) push administration over 3-5 minutes via a peripheral IV line containing normal saline (0.9% sodium chloride).

Initial dose: 190 mg/m2

Dose reductions per protocol: 150 mg/m2, 120 mg/m2 and 100 mg/m2 will be allowed for defined toxicity.

Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.

Pralatrexate Injection

1 mg intramuscular injection

Administered within 10 weeks of enrollment, every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate.

1-1.25 mg orally

Administered daily for at least 7 days prior to enrollment, throughout the study and for at least 30 days after last dose of pralatrexate.

Garry Weems, Pharm.D.

The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).

Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

A Phase 2, Single-Arm Study of Pralatrexate in Patients With Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)

Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR.

The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months)

Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scan, whichever indicates PD) or death, regardless of cause.

The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact.

Acrotech Biopharma Inc.

Serious AEs and AEs regardless of causality and all grades presented below. Symptoms present at baseline, AEs, and intercurrent illnesses were monitored at every study visit. Patients were instructed to report AEs to the investigator. All AEs including observed or volunteered problems, complaints, or symptoms were recorded.

Population consists of all patients who received at least 1 dose of pralatrexate. Pralatrexate was administered on days 1 and 15 of a 4-week cycle as an intravenous (IV) push over 3-5 minutes via a peripheral IV line containing normal saline at an initial dose of 190 mg/m2. These patients received a 1 mg intramuscular injection of Vitamin B12 within 10 weeks of enrollment and every 8-10 weeks throughout the study, and for at least 30 days after the last dose of pralatrexate. These patients were also administered 1-1.25 mg of Folic Acid orally for at least 7 days prior to enrollment, throughout the study and for at least 30 days after the last dose of pralatrexate.

Full Population

Age, Categorical

Age, Continuous

Sex: Female, Male

France

United States

Argentina

Spain

Belgium

Region of Enrollment

Medical Monitor

All patients who received at least 1 dose of pralatrexate, had histologically confirmed transitional cell carcinoma (TCC) (\> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.

Evaluable Population

Objective Response Rate (ORR)

All patients who received at least 1 dose of pralatrexate, had histologically confirmed TCC (\> 50% TCC in tumor) of the urinary bladder, and had measurable disease at baseline.

Evaluable Patients

Analysis was per protocol, based on the number of all responding patients both confirmed and unconfirmed (n=5) in the evaluable population (n=30)

Duration of Response (DOR)

Clinical Benefit Rate (CBR)

Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored.

Progression Free Survival (PFS)

Analysis per protocol. Patients who had not died or were lost to follow-up were censored

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder	NCT00722553	Carcinoma, Tran... Bladder Cancer Bladder Neoplas...	Pralatrexate In... Vitamin B12 Folic Acid	18 Years -	Acrotech Biopharma Inc.
Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder	NCT00722553	Carcinoma, Tran... Bladder Cancer Bladder Neoplas...	Pralatrexate In... Vitamin B12 Folic Acid	18 Years -	Acrotech Biopharma Inc.

Spots Global Cancer Trial Database for transitional cell carcinoma of the urinary bladder