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TumorsPhase 1NCT00313456

A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel

A Phase 1 study testing Satraplatin in people with Tumors and Prostate Cancer, run by Agennix at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single-center, open-label (sequential-group dose-escalation dose-finding) phase I study of satraplatin and docetaxel in patients who have received prior chemotherapy regimens. Once the MTD is determined, an additional 6 patients, all with chemotherapy-naïve HRPC, will be enrolled. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors, Prostate Cancer
What is being tested?
Satraplatin
Type of treatment
Pill or oral medicine
How many people
25 participants
Where
1 siteUnited States
Study dates
Mar 2006to Mar 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven advanced solid tumors.
  • 2 prior chemotherapy regimens.
  • Age greater than or equal to 18 years.
  • Eastern Cooperative Oncology Group performance status 0-1.
  • Life expectancy greater than 3 months.
  • At least 4 weeks between prior surgery or radiotherapy and enrollment.
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  • Adequate organ function as defined by the following criteria (must be obtained within 1 week of the first day of treatment):
  • Absolute neutrophil count ≥ 1500/µL. Hemoglobin ≥ 10.0 g/dl. Platelets ≥ 100,000/µL. Serum creatinine ≤ 1.5 upper limit of normal (ULN). Serum bilirubin ≤ ULN. AST/ALT ≤ 1.5 x the ULN.
  • Patients must be able to swallow capsules.
  • Patients must give written informed consent before study participation.
  • No history of another cancer within the past 5 years (except basal or squamous cell carcinoma of the skin).
  • No brain or leptomeningeal metastases.
  • Female patients must not be pregnant or lactating and must be willing to practice contraception. Males must agree to contraceptive practices.
  • For HRPC cohort
  • Patient must continue to be administered an LHRH agonist if they were receiving it at the time of screening for entry onto this protocol. Patients who have undergone bilateral orchiectomy do not need to be on LHRH agonists.
  • Patient must be off of anti-androgen medications for ≥ 6 weeks.
  • Patient must have castrate level of testosterone (< 50 ng/dL).
  • Progressive HRPC as defined by one of the following:
  • Rising PSA
  • Sequential imaging studies
  • Clinical suspicion in the view of the treating physician

Who cannot join

  • Patients who are unwilling to use contraception.
  • Patients with a history of major gastrointestinal surgery.
  • Pre-existing peripheral neuropathy > grade 1.
  • Pre-existing edema > grade 1.
  • Patients with hearing loss or tinnitus > grade 2.
  • Prior RT to >25% of the bone marrow.
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  • Concomitant use of medications that inhibit cytochrome P450 3A4 (including aprepitant).
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for non-FDA - approved indications and in the context of a research investigation).
  • Patients who have not recovered (≥ grade 1) from the following toxicities of previous regimens before enrollment:
  • hematologic toxicities (parameters defined in protocol
  • fatigue
  • mucositis
  • nausea/vomiting/diarrhea.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
  • History of HIV or AIDS related illness.
  • History of severe hypersensitivity reaction to docetaxel, polysorbate, or other drugs formulated with polysorbate 80.
  • Evidence of concurrent second malignancy.
  • History of bone marrow or major organ transplant.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sarah Cannon Research Institute

    Nashville, Tennessee

Other trials in United States

About this study

This is a single-center, open-label (sequential-group dose-escalation dose-finding) phase I study of satraplatin and docetaxel in patients who have received prior chemotherapy regimens. Once the MTD is determined, an additional 6 patients, all with chemotherapy-naïve HRPC, will be enrolled. Once a recommended dose(s) (RD(s)) for phase 2 studies has/have been determined, 6 additional patients with chemotherapy-naïve HRPC will be enrolled at the RD to further evaluate safety and efficacy.

Read the detailed description

RATIONALE:

Satraplatin is an oral platinum analog that is currently being evaluated in combination with prednisone in a phase III clinical trial in patients with HRPC who have progressed following one prior chemotherapy regimen.

Docetaxel is a taxane that is indicated for the treatment of patients with non-small cell lung, breast, and prostate cancers. Specifically, it was recently approved in combination with prednisone for the treatment of patients with hormone refractory prostate cancer (HRPC). Docetaxel administered every 3 weeks was associated with a survival advantage versus mitoxantrone. Docetaxel administered weekly showed an improvement in survival versus mitoxantrone that was not statistically significant. However, it was better tolerated than docetaxel administered every 3 weeks, with significantly less grade 3 and 4 toxicities, especially neutropenia. The combination of satraplatin and weekly docetaxel may be a feasible regimen for patients with chemotherapy-naïve HRPC and for patients with other malignancies for which these medications show activity.

OBJECTIVE:

The objective of this study is to determine the optimum doses for satraplatin and weekly docetaxel when the 2 drugs are given in combination.

Being tested
Satraplatin
Medical subject headings
Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SatraplatinDrug

    Satraplatin is an oral platinum analogue that has shown promising activity in multiple tumor settings. Satraplatin (40 to 80 mg/m2/day) will be administered orally on days 1 to 5 of a 21 day cycle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the maximum tolerated dose (MTD) of satraplatin administered every 4 weeks in combination with docetaxel administered weekly (3 of 4 weeks)

    Measured: 30 days

Secondary outcomes (2)

  1. To assess safety and tolerability (as per NCI-CTCAE version 3.0)

    Measured: 30 days

  2. To assess preliminary antitumor activity

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionMar 2009
  4. Study completionMar 2009

Why it stopped: Sponsor decided to discontinue study drug development

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00313456
Sponsor's protocol ID
SAT1-05-09
Status last verified
May 2012
First submitted
10 Apr 2006
Last updated
10 May 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Satraplatin in people with Tumors and Prostate Cancer, run by Agennix at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decided to discontinue study drug development). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the maximum tolerated dose (MTD) of satraplatin administered every 4 weeks in combination with docetaxel administered weekly (3 of 4 weeks) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00313456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.

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