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Sponsored by: |
Clavis Pharma |
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Information provided by: | Clavis Pharma |
ClinicalTrials.gov Identifier: | NCT00778128 |
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.
Condition | Intervention | Phase |
---|---|---|
Solid Tumors |
Drug: CP-4126 Drug: Gemcitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Clinical Study of Oral CP-4126 in Patients With Advanced Solid Tumour |
Estimated Enrollment: | 35 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Step 1: Dose escalation - oral CP-4126 Step 2: Oral CP-4126 on day 1 and 15 in a 4 week schedule. One dose (only) gemcitabine IV on day 8. |
Drug: CP-4126
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
Drug: Gemcitabine
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
|
2: Experimental
Step 1: Dose escalation - oral CP-4126 Step 2: Oral CP-4126 on day 8 and 15 in a 4 week schedule. One dose (only) gemcitabine IV on day 1. |
Drug: CP-4126
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
Drug: Gemcitabine
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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Radiotherapy
Contact: Ahmad H Awada, MD | +32 2 541 31 89 | ahmad.awada@bordet.be |
Belgium | |
Institute Jules Bordet | Recruiting |
Brussels, Belgium, 1000 | |
Contact: Ahmad H Awada, MD +32 2 541 31 89 ahmad.awada@bordet.be | |
Principal Investigator: Ahmad H Awada, MD | |
Netherlands | |
University Medical Centre Utrecht | Not yet recruiting |
Utrecht, Netherlands | |
Contact: Emile Voest, MD +31 887 55 62 65 e.e.voest@umcutrecht.nl | |
Principal Investigator: Emile Voest, MD | |
The Netherlands Cancer Institute | Not yet recruiting |
Amsterdam, Netherlands | |
Contact: Jan H M Schellens, MD +31 20 512 24 46 jhm@nki.nl | |
Principal Investigator: Jan H M Schellens, MD |
Principal Investigator: | Ahmad H Awada, MD | Institute Jules Bordet |
Responsible Party: | Clavis Pharma ASA ( Jean-Michel Gaullier ) |
Study ID Numbers: | CP4126-111 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778128 |
Health Authority: | Belgium: Federal Agency for Medicines and Health Products; The Netherlands: Centrale Commissie Mengsebonden Onderzoek, The Haag, Dutch Medicine Agency |
CP-4126 Cancer Metastatic |
Solid tumours Gemzitabine Gemzar |
Gemcitabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |