MedTrace Logo

Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.

NCT01878890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-01-27

Study results available
· View outcomes & findings →

Summary

Hypothesis: encouraging results of phase II study FAVE in the treatment of hormonal resistant prostate cancer lead us to continue clinical development of efavirenz. Furthermore, all available pre-clinical and clinical data lead us to conduct a Phase 1 study with efavirenz. Objective of this Phase I is to test doses above 600 mg / day in patients with cancer in order to determine the maximum tolerated dose to improve therapeutic effect.

This study is a single center Phase I trial, conduct with dose escalation scheme of efavirenz by continual reassessment method likehood approach (CRML) on solid tumours (except pancreatic cancer) and non-Hodgkin lymphoma (NHL).

Main objective is to determine the safety profile, and particularly the maximum tolerated dose of efavirenz for the treatment of patients with solid tumors (except pancreatic cancer) or NHL in therapeutic failure.

Secondary objectives are:

* Evaluate efavirenz pharmacokinetics at 2, 4 and 12 weeks;
* Evaluate objective response at 12 weeks;
* Evaluate progression free survival at 6 months;
* Assess biological progression-free survival at 6 months (prostate tumours only).

Primary Endpoint

Safety will be evaluated according to the toxicity scale NCI-CTCAE v4.0. Dose limiting toxicities will be collected during the first 28 days (+ / - 7 days) after first dose of Efavirenz and will be defined as follows:

* Any drug-related toxicity with grade ≥ 3 according to NCI-CTCAE v4.0 (except alopecia, nausea and vomiting, regardless of grade),
* Any drug-related toxicity, regardless of grade, who led a treatment delay\> 14 days,
* Score ≥ 19 HAD during treatment. Secondary Criteria
* Solid tumors: response and progression defined by RECIST v1.1 \[Eisenhauer EA et al. EJC 2009).
* Non-Hodgkin lymphomas: Response and progression defined according to Cheson criteria \[Cheson BD et al. JCO 1999\]
* Biological progression (particular case of prostate tumors): defined according to Scher \[Scher HI et al. JCO 2008\] Statistical Considerations This is a Phase I dose escalation strategy using the method CRML, described by O'Quigley and Shen \[O'Quigley et al. Biometrics 1996\] and commonly used in Phase I trials in oncology.
* Maximum number of eligible and evaluable subjects is 30.
* Six dose levels are initially defined: 600 mg, 1200 mg, 1800 mg, 2200 mg, 2600 mg, 3000 mg.
* The risk of dose limiting toxicities maximum allowed is 25%.

Conditions

Interventions

DRUG

Efavirenz 600mg

Efavirenz 600 mg (oral daily intake)

DRUG

Efavirenz 1200 mg

Efavirenz 1200mg (oral daily intake)

DRUG

Efavirenz 1800 mg

Efavirenz 1800mg (oral daily intake)

DRUG

Efavirenz 2200 mg

Efavirenz 2200mg (oral daily intake)

Sponsors & Collaborators

  • Institut Bergonié

    lead OTHER

Principal Investigators

  • Guilhem Roubaud, MD · Institut Bergonié

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-05
Primary Completion
2014-09-16
Completion
2016-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01878890 on ClinicalTrials.gov