---
title: Dose Escalation Safety Study of TL32711 in Adults With Refractory Solid Tumors or Lymphoma
nct_id: NCT00993239
overall_status: COMPLETED
phase: PHASE1
sponsor: TetraLogic Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00993239.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00993239"
ct_last_update_post_date: 2016-03-03
last_seen_at: "2026-05-12T06:27:33.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Dose Escalation Safety Study of TL32711 in Adults With Refractory Solid Tumors or Lymphoma

**Official Title:** A Phase 1, Open-Label, Non-randomized, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TL32711 in Adults With Refractory Solid Tumors or Lymphoma

**NCT ID:** [NCT00993239](https://clinicaltrials.gov/study/NCT00993239)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** TetraLogic Pharmaceuticals
- **Conditions:** Cancer
- **Start Date:** 2009-11
- **Completion Date:** 2013-03
- **CT.gov Last Update:** 2016-03-03

## Brief Summary

A Phase 1 open-label, non-randomized dose escalation study to determine the maximum tolerated dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711).

## Detailed Description

The purpose of this Phase 1 open-label, non-randomized dose escalation study is to determine the maximum tolerated dose (MTD) and characterize the safety and tolerability of Birinapant (TL32711) when administered as a 30 minute intravenous infusion once weekly for three weeks per repeated 4 week intervals in subjects with refractory solid tumors or lymphoma. Additionally study will assess anti-tumor activity, pharmacokinetics, and exploratory biomarkers as a measurement of pharmacodynamic effects.

## Eligibility

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

```
Key Inclusion Criteria:

* Advanced metastatic or unresectable malignancy that is refractory to currently available standard therapies or no effective therapy exists. The subject's malignancy must be confirmed by prior pathologic study.
* Evaluable disease (measurable or non-measurable) by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1) or Revised Response Criteria for Malignant Lymphoma (RRCML) (Cheson 2007).
* Life expectancy greater than 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Adequate renal function, defined as serum creatinine ≤ 1.5 X upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 ml/min.
* Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 3 X ULN and total bilirubin \< 1.5 X ULN.
* Adequate bone marrow function, defined as absolute neutrophil (ANC) ≥ 1,500/mm3 (≥1.5 X106/L), platelet count ≥ 75,000/mm3 (≥ 75 X106/L), and hemoglobin ≥ 10 mg/dL in the absence of transfusion.

Key Exclusion Criteria:

* Recent anti-cancer treatment defined as:

  * Standard or investigational anti-cancer therapy within 4 weeks prior to first dose of TL32711. Exception: continued hormonal interventions for sensitive diseases.
  * Radiation therapy within 2 weeks prior to the first dose of TL32711.
* Clinically significant pulmonary illness resulting in Grade ≥ 2 hypoxia (National Cancer Institute Common Terminology criteria for Adverse Events \[NCI CTCAE, v4\]) or any requirement for supplemental oxygen, or pulse oximetry less than 90% saturation on room air.
* Symptomatic or uncontrolled brain metastases requiring current treatment (less than 4 weeks from last cranial radiation or 2 weeks from last steroids).
* Impaired cardiac function or clinically significant cardiac disease.
* Ongoing auto-immune disease or with history of an auto-immune disease within the past 5 years. Auto-immune disease include but are not limited to systemic lupus erythematosis, scleroderma, rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis and regional enteritis (Crohn's disease).
* Systemic or chronic topical corticosteroids or immunosuppressive therapy within 4 weeks prior to study entry or anticipated need of systemic corticosteroids or immunosuppressive therapy during study participation.
* Skin lesions of Grade ≥ 2 severity (NCI CTCAE v4), except alopecia.
* Lack of recovery of prior adverse events to Grade ≤1 severity (NCI CTCAE v 4) (except alopecia or neuropathy) due to medications administered prior to the first dose of TL32711.
```

## Arms

- **Birinapant (TL32711)** (EXPERIMENTAL)

## Interventions

- **Birinapant (TL32711)** (DRUG) — 30 minute intravenous (IV) infusion administered once weekly for three consecutive weeks followed by a one week off (Cycle) repeated every 4 weeks as tolerated

## Primary Outcomes

- **Define the MTD** _(time frame: 4 weeks (Cycle 1))_

## Secondary Outcomes

- **Tumor burden according to Response Evaluation Criteria in Solid Tumors (RECIST)/Revised Response Criteria Malignant Lymphoma** _(time frame: Every 8 weeks (2 cycles) while on treatment)_
- **Translational biomarkers and pharmacokinetics** _(time frame: First and third dose of Cycle 1 and after every two cycles (biomarkers only) while on treatment)_

## Locations (3)

- Roswell Park Cancer Institute, Buffalo, New York, United States
- University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
- Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — 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.roswell park cancer institute|buffalo|new york|united states` — added _(2026-05-12)_
- `locations.university of pennsylvania abramson cancer center|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.fox chase cancer center|philadelphia|pennsylvania|united states` — added _(2026-05-12)_

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*Canonical: https://parkinsonspathways.com/agent/trials/NCT00993239.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00993239*  
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