A Safety, Tolerability, And Pharmacokinetic Trial With CVX-241 In Patients With Advanced Solid Tumors

NCT01004822 | Terminated Phase 1 Results

• 2 other identifiers: B1561001CVX-241-101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when given as weekly infusions to adult patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Keywords

Treatment Non-Randomized Single Group Assignment Safety Study Neoplasms Carcinoma Cancer Malignancy

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose (MTD)

  MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).

  Stage 1: Baseline up to Day 28 (end of cycle 1)

• Recommended Phase 2 Dose (RP2D)

  RP2D was the highest dose where 0 of 3 or less than (\<2) out of 6 participants experience a DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).

  Stage 1: Baseline up to Day 28 (end of cycle 1)

Secondary Outcomes (13)

• Number of Participants With Dose Limiting Toxicities (DLTs)

  Stage 1: Baseline up to Week 4

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)

  Baseline up to 28 days after last dose of study medication (last dose = up to Cycle 39)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]

  Pre-dose, 1, 2, 4, 6 hours post dose at Day 1 of cycle 1

• Maximum Observed Plasma Concentration (Cmax)

  Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1

• Minimum Observed Plasma Trough Concentration (Cmin)

  Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1

Study Arms (1)

Active Drug

EXPERIMENTAL

Weekly infusions of CVX-241 at specified doses

Drug: CVX-241

Interventions

CVX-241 DRUG

0.3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Also known as: PF-05057459

Active Drug

Eligibility Criteria

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

You may qualify if:

• Confirmed solid tumors unresponsive to current therapy or for which there is no standard therapy.
• Stage 2 only: Histologically or cytologically documented EOC or PPC with \< or equal to 3 previous anti-cancer therapies, but at least 1 prior platinum containing regimen.
• Adequate coagulation, liver, and renal function.
• Candidate for Dynamic Contrast-Enhanced Magnetic Resonance Imaging \[DCE-MRI\] evaluation
• Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1

You may not qualify if:

• History of clinically significant toxicity to Vascular Endothelial Growth Factor \[VEGF\] inhibition.
• Evidence of bleeding problems.
• Uncontrolled hypertension.
• Patients with primary brain cancer and/or non-small cell lung cancer of squamous cell histology

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Premiere Oncology of Arizona

Scottsdale, Arizona, 85258, United States

Location

Premiere Oncology, A Medical Corporation

Santa Monica, California, 90404, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Limitations and Caveats

The study was terminated early by the sponsor due to lack of significant pharmacological effects (safety/Pharmacodynamics/efficacy) through 25 mg/kg cohort. Hence, no participant could reach out to Stage 2.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 30, 2009
• Study Start: March 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 20, 2015
• Results First Posted: July 2, 2015

Record last verified: 2015-10

Locations

US (3)