Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-05-31

Brief Summary

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This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.

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Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TH-302 plus Nab-paclitaxel plus Gemcitabine

Group Type EXPERIMENTAL

TH-302

Intervention Type DRUG

TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Nab-paclitaxel

Intervention Type DRUG

Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Gemcitabine

Intervention Type DRUG

Gemcitabine will be administered at a dose ranging from 800-1000 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Interventions

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TH-302

TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Intervention Type DRUG

Nab-paclitaxel

Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Intervention Type DRUG

Gemcitabine

Gemcitabine will be administered at a dose ranging from 800-1000 mg/m\^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects greater than or equal to (\>=) 18 years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:

* Radiosensitizing doses of 5-fluorouracil;
* Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
* Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
* Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
* Subjects may have measurable or non-measurable disease according to RECIST 1.1.
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* Acceptable hematological status, liver and renal function as defined in the protocol

Exclusion Criteria

* Significant cardiac or peripheral vascular arterial disease
* Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
* Severe chronic obstructive or other pulmonary disease with hypoxemia
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Subjects receiving concomitant treatment with radiotherapy or other investigational drugs

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No