Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies

NCT01930292 | Terminated Phase 1

• 2 other identifiers: Debio 1143-1032012-003676-40
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief Summary

This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC). The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin. The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Part A: Number of participants with dose-limiting toxicities

  Categories: each Debio 1143 dose level and overall

  up to 18 weeks

• Part B: Percentage of participants with adverse events (AEs) and serious AEs (SAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria

  up to 18 weeks + 28 days

Secondary Outcomes (42)

• Part A: Percentage of participants with AEs and serious adverse events (SAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria

  up to 18 weeks + 28 days

• Part A: Number of participants with change in vital signs

  up to 18 weeks

• Part A: Number of participants with change in electrocardiogram (ECG)

  up to 18 weeks

• Part A: Number of participants with change in Eastern Cooperative Oncology Group (ECOG) performance status (PS)

  up to 18 weeks

• Part B: Number of participants with change in vital signs

  up to 18 weeks

Study Arms (4)

Part A: Debio 1143

EXPERIMENTAL

Eligible participants receive Part A: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle according to dose escalation rules (in combination with Paclitaxel and Carboplatin standard of care)

Drug: Part A: Debio 1143; Drug: Paclitaxel; Drug: Carboplatin

Part B: Lung Cancer

EXPERIMENTAL

Participants with Lung Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care)

Drug: Paclitaxel; Drug: Carboplatin; Drug: Part B: Debio 1143

Part B: Ovarian Cancer

EXPERIMENTAL

Participants with Ovarian Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care)

Drug: Paclitaxel; Drug: Carboplatin; Drug: Part B: Debio 1143

Part B: Breast Cancer

EXPERIMENTAL

Participants with Breast Cancer receive Part B: Debio 1143 once daily for 5 consecutive days in each 21-day treatment cycle (in combination with Paclitaxel and Carboplatin standard of care)

Drug: Paclitaxel; Drug: Carboplatin; Drug: Part B: Debio 1143

Interventions

Part A: Debio 1143 DRUG

Adaptive doses of Debio1143 oral capsules, between 50 and 400 mg until the recommended dose (RD) is determined.

Part A: Debio 1143

Paclitaxel DRUG

Paclitaxel standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle, after pre-medication to prevent severe hypersensitivity reactions.

Part A: Debio 1143; Part B: Breast Cancer; Part B: Lung Cancer; Part B: Ovarian Cancer

Carboplatin DRUG

Carboplatin standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle.

Part A: Debio 1143; Part B: Breast Cancer; Part B: Lung Cancer; Part B: Ovarian Cancer

Part B: Debio 1143 DRUG

RD of Debio1143 oral capsules, once daily for five consecutive days starting on day 1 or 2 of each 21-day treatment cycle.

Part B: Breast Cancer; Part B: Lung Cancer; Part B: Ovarian Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets protocol-specified criteria for qualification and contraception
• Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

You may not qualify if:

• Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
• the safety or well-being of the participant or study staff;
• the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); or
• the analysis of results

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (4)

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Curie

Paris, 75248, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Related Links

• Site Debiopharm SA

MeSH Terms

Interventions

Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Jean-Pierre Delord, MD

  Institut Claudius Regaud, Toulouse, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: August 28, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 24, 2016

Record last verified: 2016-03

Locations

FR (4)