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A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Triple Negative Metastatic Breast Cancer, Advanced Ovarian Cancer, Carboplatin, Paclitaxel

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Trial Information

A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours


Inclusion Criteria:



- Male or female patients with a histologically or cytologically diagnosed malignant
solid tumour

- Adequate bone marrow, hepatic and renal function

- Performance status of no more than 2 ( ECOG scale).

Exclusion Criteria:

- Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy
within 4 weeks prior to entry

- Major surgery with 4 weeks of entering the study and must have recovered from effects
of the major surgery

- More than two previous courses of platinum-containing chemotherapy

- Heavily pre-treated patients(> 2 courses of previous chemotherapy and/or extensive
irradiation leading to bone marrow deficiency) will be excluded from the study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with Paclitaxel/Carboplatin

Outcome Time Frame:

assessed at each visit

Safety Issue:

No

Principal Investigator

Jane Robertson, BSc, MBCHB, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D0810C00004

NCT ID:

NCT00516724

Start Date:

June 2007

Completion Date:

August 2013

Related Keywords:

  • Triple Negative Metastatic Breast Cancer
  • Advanced Ovarian Cancer
  • Carboplatin
  • Paclitaxel
  • malignant solid tumours
  • Poly(ADP ribose) polymerases
  • Breast Neoplasms
  • Ovarian Neoplasms

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