Trial of PM02734 Administered in Combination With Erlotinib in Patients With Advanced Malignant Solid Tumors

Part of paid clinical trials in New York, New York.

Sponsor
PharmaMar
Study ID
NCT00884845
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Malignant Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PM02734 and erlotinib — DRUG
    PM02734 drug product (DP) 1 mg/vial is a powder for concentrate for solution for infusion
  • Erlotinib — DRUG
    Erlotinib is provided as 25 mg, 100 mg and 150 mg white film-coated tablets

Study Details

Phase I multicenter, open-label, dose-escalating clinical and pharmacokinetic trial of PM02734 administered in combination with erlotinib to determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib, in patients with advanced malignant solid tumors.

Key Dates

First listed
Apr 21, 2009
Start date
Jan 31, 2009
Status verified
Mar 2014
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
35 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Administration of i.v. infusions of PM02734 (on Days 1, 8 and 15) every three weeks and a daily oral dose of erlotinib

Primary Outcome Measure

To determine the safety and tolerability and to identify the dose limiting toxicity (DLT) and the recommended dose (RD) of the combination of PM02734 and erlotinib [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterNew YorkNew York10467-2490-

Find similar trials in New York, NY

By research site
Montefiore Medical Center· New York, NY

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