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A Phase 1b Dose-escalation Study to Evaluate the Safety and Tolerability of the Addition of the Aminopeptidase Inhibitor CHR-2797 to Paclitaxel in Patients With Advanced or Refractory Tumours

Phase 1
18 Years
Not Enrolling
Solid Tumor

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Trial Information

A Phase 1b Dose-escalation Study to Evaluate the Safety and Tolerability of the Addition of the Aminopeptidase Inhibitor CHR-2797 to Paclitaxel in Patients With Advanced or Refractory Tumours

Inclusion Criteria:

- Signed, informed consent.

- Age > 18 years

- Histologically or cytologically documented locally advanced or metastatic solid
tumour refractory to standard therapy or for which no standard therapy exists.

- Patients should have recovered from the acute adverse effects of prior therapies
(excluding alopecia).

- Adequate bone marrow, hepatic and renal function including the following:

- Hb > 9g/dl (transfusion independent) or >10g/dl (transfusion permitted), absolute
neutrophil count > 1.5 x 109/L, platelets ≥ 100 x 109/L;

- Total bilirubin ≤ 1.5 x upper normal limit;

- AST (SGOT), ALT (SGPT) ≤ 2.5 x upper normal limit

- Creatinine ≤1.5 x upper normal limit.

- Performance status (PS) ≤ 2 (ECOG scale).

- Estimated life-expectancy greater than 3 months.

- Female patients with reproductive potential must have a negative serum pregnancy test
within 7 days prior to start of trial. Both women and men must agree to use a
medically acceptable method of contraception throughout the treatment period and for
3 months after discontinuation of treatment.

Exclusion Criteria:

- Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy,
immunotherapy or use of other investigational agents within the 4 weeks prior to
first dose of medication in this trial or within a longer period, depending on the
defined characteristics of the agent e.g. 6 weeks for nitrosurea or mitomycin.
Bisphosphonates for bone disease are permitted provided the doses are stable before
and during the trial.

- Co-existing active infection or serious concurrent illness.

- Significant cardiovascular disease as defined by:

- history of congestive heart failure requiring therapy;

- history of unstable angina pectoris or myocardial infarction up to 6 months
prior to trial entry;

- presence of severe valvular heart disease;

- presence of a ventricular arrhythmia requiring treatment.

- Any co-existing medical condition that in the investigator's judgement will

- substantially increase the risk associated with the patient's participation in the

- Psychiatric disorders or altered mental status precluding understanding of the

- informed consent process and/or completion of the necessary studies.

- Gastrointestinal disorders that may interfere with absorption of the study drug.

- Persistent grade II or greater toxicity from any cause.

- Patients with known brain tumours or metastases should be excluded from this clinical
trial because of their poor prognosis and because they often develop progressive
neurological dysfunction that would confound the evaluation of neurologic and other
adverse events.

- More than 4 prior chemotherapy regimens.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of CHR-2797 when administered in combination with paclitaxel.

Outcome Time Frame:

18 weeks

Safety Issue:


Principal Investigator

Carla van Herpen

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC St Radboud


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

August 2006

Completion Date:

March 2008

Related Keywords:

  • Solid Tumor
  • Solid tumour
  • Solid tumor
  • Pharmacokinetic
  • Interaction
  • dose escalation
  • cancer
  • paclitaxel