---
title: Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
nct_id: NCT02449681
overall_status: TERMINATED
phase: PHASE2
sponsor: Rain Oncology Inc
study_type: INTERVENTIONAL
primary_condition: Metastatic Head-and-neck Squamous-cell Carcinoma
countries: United States, Australia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02449681.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02449681"
ct_last_update_post_date: 2023-01-12
last_seen_at: "2026-05-12T07:16:32.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin

**Official Title:** A Phase 2 Study of Tarloxotinib (TH-4000) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin

**NCT ID:** [NCT02449681](https://clinicaltrials.gov/study/NCT02449681)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Lack of efficacy
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Rain Oncology Inc
- **Conditions:** Metastatic Head-and-neck Squamous-cell Carcinoma
- **Start Date:** 2015-08
- **Completion Date:** 2017-01-31
- **CT.gov Last Update:** 2023-01-12

## Brief Summary

This phase 2 study is designed to evaluate the safety and activity of TH-4000, a hypoxia-activated prodrug in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.

## Detailed Description

An open label, multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.

Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin
* For patients with oropharyngeal cancer, p16 status is known or can be determined
* Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Acceptable laboratory results as indicated by protocol
* Acceptable cardiac function as indicated by protocol

Exclusion Criteria:

* Received prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy for recurrent or metastatic Squamous Cell Carcinoma (e.g., oral EGFR TKIs such as erlotinib, gefitinib, or afatinib)
* Family history of long corrected QT interval (QTc) syndrome
* Receiving medication that prolongs QT interval ,with a risk of causing Torsades de Pointes (TdP), unless ECG meets inclusion criteria while on a stable dose of the medication
* Family history of long QTc syndrome
* Symptomatic central nervous system (CNS) lesions, or CNS lesions that require therapy
* Radiation therapy within 2 weeks prior to the first dose of study medication
* Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
* Concurrent active malignancy requiring systemic treatment
* Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
* Pregnant or breast-feeding
```

## Arms

- **TH-4000 (Tarloxotinib)** (EXPERIMENTAL) — TH-4000 150 mg/m2 will be administered by IV infusion over 60 minutes on Days 1, 8, 15 and 22 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.

## Interventions

- **TH-4000 (Tarloxotinib)** (DRUG)

## Primary Outcomes

- **Number of participants with response rate as evaluated by RECIST criteria** _(time frame: Approximately 12 months)_

## Secondary Outcomes

- **Incidence of adverse events (AEs)** _(time frame: Up to 30 days after last dose)_
- **Type of adverse events (AEs)** _(time frame: Up to 30 days after last dose)_
- **Severity of adverse events (AEs)** _(time frame: Up to 30 days after last dose)_
- **Duration of response (DOR) calculated for all patients achieving an objective response** _(time frame: Approximately 12 months)_
- **Progression-free survival (PFS)** _(time frame: Approximately 12 months)_
- **Overall Survival (OS)** _(time frame: Approximately 12 months)_
- **Maximum plasma concentration of TH-4000 (prodrug) and TH-4000E (TKI effector)** _(time frame: Cycle 1 Day 1 predose and up to 24 hours postdose)_
- **Area under the plasma concentration versus time curve of TH4000 (prodrug) and TH-4000E (TKI effector)** _(time frame: Cycle 1 Day 1 predose and up to 24 hours postdose)_
- **QTc Interval** _(time frame: Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 and study Termination)_

## Locations (10)

- University of Southern California-Norris, Los Angeles, California, United States
- Stanford school of Medicine, Stanford, California, United States
- Georgetown Medical Center, Washington D.C., District of Columbia, United States
- University of Chicago, Chicago, Illinois, United States
- Walter Reed National Military Cancer Center, Bethesda, Maryland, United States
- Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
- Vanderbilt-Ingram Cancer Center (VICC), Nashville, Tennessee, United States
- UT Southwestern Medical Center, Dallas, Texas, United States
- Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
- Peter MacCallum, East Melbourne, Victoria, Australia

## Recent Field Changes (last 30 days)

- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of southern california-norris|los angeles|california|united states` — added _(2026-05-12)_
- `locations.stanford school of medicine|stanford|california|united states` — added _(2026-05-12)_
- `locations.georgetown medical center|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.university of chicago|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.walter reed national military cancer center|bethesda|maryland|united states` — added _(2026-05-12)_
- `locations.fox chase cancer center|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.vanderbilt-ingram cancer center (vicc)|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.ut southwestern medical center|dallas|texas|united states` — added _(2026-05-12)_
- `locations.chris o'brien lifehouse|camperdown|new south wales|australia` — added _(2026-05-12)_
- `locations.peter maccallum|east melbourne|victoria|australia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02449681.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02449681*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*