Study of Cabozantinib (XL184) in Adults With Advanced Malignancies

Conditions

• Cancer
• Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib — DRUG
• Placebo — DRUG

Study Details

This is a Phase 2 study to evaluate the efficacy and safety of cabozantinib (XL184) in subjects with selected advanced tumor types.

Key Dates

Start date

Sep 30, 2009

Status verified

Dec 2023

Primary completion

May 31, 2013

Completion

Jun 30, 2014

Study Design

Enrollment

730 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Lead-in Stage - cabozantinib (XL184)
  Open Label, cabozantinib, 100 mg, po QD for 12 weeks.
• Experimental: Randomized Stage - cabozantinib (XL184)
  Blinded, cabozantinib, 100 mg, po QD until disease progression.
• Placebo Comparator: Randomized Stage - placebo
  Blinded, placebo, 100 mg, po QD until disease progression.
• Experimental: Open-Label Extension - cabozantinib (XL184)
  Open Label, cabozantinib, for subjects that were on placebo during the randomized stage, 100 mg, po QD until disease progression or unacceptable toxicity.
• Experimental: Non-Randomized Expansion (NRE) Cohort - Castrate Resistant Prostate Cancer (CRPC), 100mg
  Open Label, cabozantinib, 100 mg, po QD until disease progression or unacceptable toxicity.
• Experimental: Non-Randomized Expansion (NRE) Cohort - Castrate Resistant Prostate Cancer (CRPC), 39.4mg
  Open Label, cabozantinib, 39.4, po QD until disease progression or unacceptable toxicity.
• Experimental: A. Non-Randomized Expansion (NRE) Cohort - Ovarian
  Open Label, cabozantinib, 100 mg, po QD until disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (ORR) - LEAD IN STAGE, RDT Cohorts and NRE Ovarian Cohort Only [ Time Frame: From initial dose through final study visit up to 44 months ]

Locations (34)

Find similar trials in Scottsdale, AZ

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