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A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC] (HALO)

Primary Purpose

Non-small Cell Lung Cancer

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Debio 0932

Cisplatin

Pemetrexed

Gemcitabine

Docetaxel

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Safety, Efficacy, HSP90, Debio 0932, Standard of care treatment, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (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 Response Evaluation Criteria in Solid Tumors (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

Sites / Locations

Centre GF Leclerc
Centre Léon Bérard
Institut de Cancérologie de l'Ouest- Institut René Gauduchau
Institut Claudius Regaud
Hospital Universitari Vall d'Hebron
Hospital Puerta de Hierro Majadahonda
Hospital Universitario Virgen del Rocío
Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cisplatin, Pemetrexed, Debio 0932

Cisplatin, Gemcitabine, Debio 0932

Docetaxel, Debio 0932

Arm Description

Cisplatin, Pemetrexed, Debio 0932

Cisplatin, Gemcitabine, Debio 0932

Docetaxel, Debio 0932

Outcomes

Primary Outcome Measures

Occurrence of Dose Limiting Toxicities

Secondary Outcome Measures

Change in vital signs and Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Incidence of laboratory abnormalities

Incidence of treatment discontinuations due to AEs and SAEs

Change in left ventricular ejection fraction (LVEF)

Pharmacokinetic parameters of Debio 0932 and its metabolite Debio 0932-MET1

Pharmacokinetic parameters of cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel

Best overall tumor response

Pharmacodynamic biomarkers

Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932

Full Information

NCT ID

NCT01714037

First Posted

October 3, 2012

Last Updated

April 7, 2015

Sponsor

Debiopharm International SA

Collaborators

Syneos Health

1. Study Identification

Unique Protocol Identification Number

NCT01714037

Brief Title

A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]

Acronym

HALO

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Study Start Date

August 2012 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Debiopharm International SA

Collaborators

Syneos Health

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

Safety, Efficacy, HSP90, Debio 0932, Standard of care treatment, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cisplatin, Pemetrexed, Debio 0932

Arm Type

Experimental

Arm Description

Cisplatin, Pemetrexed, Debio 0932

Arm Title

Cisplatin, Gemcitabine, Debio 0932

Arm Type

Experimental

Arm Description

Cisplatin, Gemcitabine, Debio 0932

Arm Title

Docetaxel, Debio 0932

Arm Type

Experimental

Arm Description

Docetaxel, Debio 0932

Intervention Type

Drug

Intervention Name(s)

Debio 0932

Intervention Description

Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Cisplatin 75 mg/m2 body surface area (BSA) will be administered on Day 1 of each 21-day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

Pemetrexed 500 mg/m2 BSA will be administered on Day 1 of each 21 day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle.

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.

Primary Outcome Measure Information:

Title

Occurrence of Dose Limiting Toxicities

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change in vital signs and Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Time Frame

Day 1 of each treatment cycle until disease progression or study drug toxicity

Title

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame

Every treatment cycle until disease progression or study drug toxicity

Title

Incidence of laboratory abnormalities

Time Frame

2 to 4 times every treatment cycle until disease progression or study drug toxicity

Title

Incidence of treatment discontinuations due to AEs and SAEs

Time Frame

Every treatment cycle until diseases progression or study drug toxicity

Title

Change in left ventricular ejection fraction (LVEF)

Time Frame

Baseline and after 4 weeks of treatment

Title

Pharmacokinetic parameters of Debio 0932 and its metabolite Debio 0932-MET1

Time Frame

22 days

Title

Pharmacokinetic parameters of cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel

Time Frame

22 days

Title

Best overall tumor response

Time Frame

22 days

Title

Pharmacodynamic biomarkers

Time Frame

22 days

Title

Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (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 Response Evaluation Criteria in Solid Tumors (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

Overall Study Officials: