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

Debiopharm

Status and phase: Terminated; Phase 1

Conditions: Solid Tumors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01930292

2012-003676-40 (EudraCT Number)

Debio 1143-103

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); or
  3. the analysis of results

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 4 patient groups

Part A: Debio 1143

Experimental group

Description:

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)

Treatment:

Drug: Carboplatin

Drug: Part A: Debio 1143

Drug: Paclitaxel

Part B: Lung Cancer

Experimental group

Description:

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)

Treatment:

Drug: Carboplatin

Drug: Part B: Debio 1143

Drug: Paclitaxel

Part B: Ovarian Cancer

Experimental group

Description:

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)

Treatment:

Drug: Carboplatin

Drug: Part B: Debio 1143

Drug: Paclitaxel

Part B: Breast Cancer

Experimental group

Description:

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)

Treatment:

Drug: Carboplatin

Drug: Part B: Debio 1143

Drug: Paclitaxel