A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Picoplatin is a new platinum-based chemotherapy drug that has been studied in a variety of cancers. Phase 1 and 2 studies have demonstrated that picoplatin may be effective in patients whose cancer returns or does not improve after treatment with chemotherapy. In these studies, picoplatin was administered intravenously. A capsule containing picoplatin has been formulated. This study will investigate the activity of the oral capsule in humans. Participants with advanced solid tumors will be enrolled.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combretastatin A4 Phosphate in Treating Patients With Advanced Solid Tumors

NCT00003768

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Sorafenib/ Carboplatin/ Paclitaxel in Patients With Solid Tumors

NCT00606125

Neoplasms

COMPLETED PHASE1

Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer

NCT00003917

Lung Cancer

COMPLETED PHASE3

Cyclophosphamide Drug Interaction Study In Cancer Patients

NCT00334646

Nausea and Vomiting, Chemotherapy-Induced

TERMINATED PHASE1

MTD Determination, Safety and Efficacy of the Decitabine-Genistein Drug Combination in Advanced Solid Tumors and Non-Small Cell Lung Cancer

NCT01628471

Non Small Cell Lung Cancer

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary study design is a randomized, two-period crossover, open label study in which a single dose (Cycle 1) of picoplatin will be given either IV or by oral capsule, followed 4 weeks later by a single dose (Cycle 2) of picoplatin given either IV or by oral capsule (whichever route was not used in Cycle 1). Participants may continue to receive cycles of IV picoplatin every 3 weeks, beginning with Cycle 3, as part of a Continuation Study.

This study will determine the relative safety, bioavailability, pharmacokinetics, pharmacodynamics, and urinary excretion of picoplatin administered orally with reference to picoplatin administered intravenously.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer Breast Cancer Colorectal Cancer Gastrointestinal Neoplasm Head and Neck Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

two-period crossover, open label study in which a single dose (Cycle 1) of picoplatin will be given either IV or PO, followed 4 weeks later by a single dose (Cycle 2) of picoplatin given by the route not used for Cycle 1. Subjects subsequently may continue to receive IV picoplatin commencing with Cycle 3 in a Continuation Study.

Group Type EXPERIMENTAL

Picoplatin

Intervention Type DRUG

The IV dose will be 120 mg/m2. Three oral dose levels will be studied sequentially (6 subjects per dose level) in the absence of dose limiting toxicity 200 mg, 300 mg, or 400 mg total dose.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Picoplatin

The IV dose will be 120 mg/m2. Three oral dose levels will be studied sequentially (6 subjects per dose level) in the absence of dose limiting toxicity 200 mg, 300 mg, or 400 mg total dose.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histological diagnosis of non-hematological malignancy.
* Patients for whom no standard therapy exists and for whom, in the opinion of the investigator, treatments with single agent picoplatin is appropriate.
* 18 years of age or older.
* ECOG performance status 0-2.
* Life expectancy of at least 12 weeks.

Exclusion Criteria

* Symptomatic or uncontrolled brain metastases.
* Prior radiation involving ≥ 30% of the total bone marrow space.
* Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study.
* Gastrointestinal surgery that might interfere with absorption of orally administered drug.
* Active inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding.
* Clinical evidence of pancreatic injury or active pancreatitis.
* Female subjects who are pregnant or breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No