Know Cancer

or
forgot password

A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)


Part A of this study will determine the Maximum Tolerated Dose of Debio 0932 in combination
with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage
IIIb or IV NSCLC, and with docetaxel in previously treated patients with Stage IIIb or IV
NSCLC.

Escalating doses of Debio 0932 will be given to subsequent patients in combination with
standard doses of these 3 background chemotherapies.


Inclusion Criteria:



- Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without
known EGFR mutation

- Advanced or metastatic disease (Stage IIIb or IV)

- Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No
previous systemic treatment with chemotherapy, targeted therapy or investigational
agents (except adjuvant therapy if > 6 months ago); Patients to be treated with
docetaxel: ≥ 1 previous treatment with chemotherapy

- Measurable disease by the RECIST criteria

- ECOG performance score 0-1

- Life expectancy ≥ 3 months

- Adequate bone marrow-, renal- and hepatic function

- LVEF ≥ 55% on cardiac ultrasound

Exclusion Criteria:

- Symptomatic brain metastases

- Gastro-intestinal disorders that could affect drug absorption (including, but not
limited to, major abdominal surgery, significant bowel obstruction, ulcerative
colitis, Crohn's disease)

- Concurrent treatment with any other systemic anti-cancer therapy

- Serious concomitant uncontrolled medical conditions

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of Dose Limiting Toxicities

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Nicolas Isambert, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre GF Leclerc, Dijon, France

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

Debio 0932-201

NCT ID:

NCT01714037

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Safety, efficacy, HSP90, Debio 0932, standard of care treatment, NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location