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Completed

NCT Number: NCT00778128

A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour

At step 1, patients with advanced solid tumors will receive CP-4126 capsules following a dose escalation schedule until the maximum tolerated dose is reached. At step 2, 20 patients will be randomized. They will receive at days 1 and 8 in a double cross design either oral CP-4126 at the recommended dose or gemcitabine 1000mg/m2 intravenously. At both steps, the schedule of treatment will be day 1, 8, 15 q4w until complete response or disease worsening/ progressing. All further treatment at step 2 will be oral CP-4126.

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Key information

Conditions

Solid Tumors Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute Jules Bordet, Brussels, Belgium

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About this study

This is a multicentre clinical study conducted in Belgium and in The Netherlands. The study is a phase I divided in 2 steps: The first step is a dose escalation to define the RD. At the second step the PK profile of oral CP-4126 will be compared with the PK profile of IV gemcitabine. In addition, the study is conducted to characterize the tolerability of oral CP-4126, to evaluate its bioavailability, and to make a preliminary assessment of antitumor activity in patients with solid tumours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed solid tumour diagnosis
  • Locally advanced or metastatic disease, for which there is no known effective treatment
  • Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
  • Age 18 years or more
  • Life expectancy > 3 months
  • Adequate hematological and biological functions:
  • Signed informed consent

Exclusion criteria

  • Symptomatic brain metastases
  • Current peripheral neuropathy of grade > 1 according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
  • Radiotherapy
  • to more than 30 % of bone marrow
  • single dose up to 8 Gy
  • less than one week prior to the study treatment
  • of the upper GI tract
  • Mucositis of the upper digestive tract, including stomatitis
  • Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
  • Previous anticancer therapy (chemotherapy, hormone therapy or immunotherapy) within 30 days prior to the first dose of oral CP-4126 [6 weeks for mitomycin C and BCNU (= carmustine) and CCNU (=lomustine)]
  • Requirement of concomitant treatment with a non-permitted medication including alternative drugs and high doses of vitamins
  • History of allergic reactions to gemcitabine
  • Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
  • Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
  • Pregnant or breast feeding women
  • Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment
  • Known positive status for HIV and/or hepatitis B or C
  • Any reason why, in the investigator's opinion, the patient should not participate
  • Condition that impairs ability to swallow pills
  • Coeliac disease or any other lipid malabsorption syndrome
  • Drug and/or alcohol abuse

Treatment and study plan

CP-4126

Drug

Step 1: Dose escalation oral CP-4126 until maximum tolerated dose. Step 2: Oral CP-4126 day 1 and 15 + IV Gemcitabine 1000 mg/m2 day 8 in a 4 week schedule until complete response or disease worsening / progression

Gemcitabine

Drug

Step 1: Dose escalation oral CP-4126 until maximum tolerated dose Step 2: Oral CP-4126 day 8 and 15 + IV Gemcitabine 1000 mg/m2 day 1 in a 4 week schedule until complete response or disease worsening / progression

Primary outcomes

  1. Step 1: MTD of oral CP-4126 in patients with advanced solid tumours, followed by establishing the recommended dose

    Time frame: 6 months

  2. Step 2: Pharmacokinetic parameters comparison of oral CP-4126 with IV gemcitabine

    Time frame: 12 months

Secondary outcomes

  1. Tolerability of oral CP-4126

    Time frame: 12 months

  2. Biovailability of oral CP-4126

    Time frame: 12 months

  3. Preliminary assessment of antitumor activity of oral CP-4126

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Clavis Pharma

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 23, 2008
Registry last updated
Sep 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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