Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer (X-PECT)

AEterna Zentaris

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: Capecitabine; Drug: Placebo; Drug: Perifosine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01097018

Protocol 343

Details and patient eligibility

About

The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.

Enrollment: 468 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies.
• For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity.
• No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine
• Patients must have at least one measurable lesion by RECIST criteria

Exclusion criteria

• Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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468 participants in 2 patient groups, including a placebo group

Perifosine + Capecitabine

Active Comparator group

Description:

Perifosine 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days

Treatment:

Drug: Capecitabine

Drug: Perifosine

Placebo + Capecitabine

Placebo Comparator group

Description:

Placebo 1 tablet daily + Capecitabine BID days 1 - 14 every 21 days

Treatment:

Drug: Capecitabine

Drug: Placebo