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

Browse trials for

• Carcinoma, Transitional Cell 725
• Urinary Bladder Neoplasms 1,649
• Carcinoma 6,719
• Neoplasm Metastasis 3,562
• Recurrence 4,347

Keywords

• Transitional Cell Carcinoma of the Urinary Bladder
• Transitional Cell Carcinoma
• Bladder Cancer
• Urinary Bladder Cancer
• Bladder
• Carcinoma
• Urinary
• Metastatic
• Relapsed

Carcinoma, Transitional Cell

725 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 556 interventional studies indexed under Carcinoma, Transitional Cell.

Lead sponsor

Acrotech Biopharma Inc. is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Study arms

• Other
  Dietary Supplement Vitamin B12 & Folic Acid (Vitamin B9)

  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.

  Drug: Pralatrexate Injection · Dietary Supplement: Vitamin B12 · Dietary Supplement: Folic Acid

Interventions

• DrugPralatrexate Injection

  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.

  Also known as: FOLOTYN, PDX, Pralatrexate, (RS)-10-propargyl-10-deazaaminopterin

• Dietary supplementVitamin 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.

  Also known as: Cyanocobalamin

• Dietary supplementFolic 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.

  Also known as: Vitamin B9, Folate, Folacin

Primary outcomes

1. Objective Response Rate (ORR)

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

   Time frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended for up to 2 years after enrollment.

Secondary outcomes

1. Duration of Response (DOR)

   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.

   Time frame: Measured from the first day of documented response for up to 2 years after enrollment.

2. Clinical Benefit Rate (CBR)

   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)

   Time frame: Assessed at the end of each even-numbered cycle (every 8 weeks) or per standard of care, but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.

3. Progression Free Survival (PFS)

   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.

   Time frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.

4. Overall Survival (OS)

   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.

   Time frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care if treatment has ended (at least every 12 weeks) for up to 2 years after enrollment. After PD or start of subsequent treatment, OS will be assessed every 4 months.

Baseline characteristics