A Phase I Dose Escalation Trial of Afatinib Plus Gemcitabine or Plus Docetaxel

An observational study of Neoplasms, run by Boehringer Ingelheim at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors. To assess the safety of the combination. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: Afatinib, docetaxel and gemcitabine
How many people: 94 participants
Where: 3 sitesFrance
Study dates: Nov 2010to Apr 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: solid tumors

Who may be able to join

1. histologically or cytologically confirmed diagnosis of any advanced or metastatic relapsed or refractory solid tumor.

Who cannot join

Active brain metastases
Patients with known pre-existing interstitial lung disease

Trial locations and contacts

3 sites in 1 country.

France3 sites

1200.93.33002 Boehringer Ingelheim Investigational Site
Dijon
1200.93.33001 Boehringer Ingelheim Investigational Site
Saint-Herblain
1200.93.33003 Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

About this study

Official title: A Phase I Dose Escalation Trial of Once Daily Oral Treatment Using Afatinib (BIBW2992) Plus Gemcitabine or Docetaxel in Patients With Relapsed or Refractory Solid Tumors.

To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors.

To assess the safety of the combination. To investigate the PK characteristics of docetaxel or gemcitabine and of oral afatinib (BIBW2992) in the tested treatment schedule. To assess antitumor activity.

Conditions: Neoplasms
Being tested: Afatinib, docetaxel, gemcitabine
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AfatinibDrug
Maximum Tolerated Dose of Afatinib in combination with gemcitabine
AfatinibDrug
Maximum Tolerated Dose of Afatinib in combination with gemcitabine
docetaxelDrug
Maximum Tolerated Dose of Afatinib in combination with docetaxel
gemcitabineDrug
Maximum Tolerated Dose of Afatinib in combination with gemcitabine

Study groups in NCT01251653
Study group	Role	What they receive
Afatinib and docetaxel		Not described Receives: Drug: Afatinib; Drug: docetaxel
Afatinib and gemcitabine		Not described Receives: Drug: Afatinib; Drug: gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).
DLT was based on following criterions: 1. Grade 4 uncomplicated (not associated with fever >38.5° C (Celsius)) neutropenia for ≥7 days. 2. Grade 3 or 4 neutropenia concomitant with fever >38.5º C or Grade ≥3 infection. 3. Platelet count of <25x 10^9/L or <50x 10^9/L with bleeding requiring whole blood transfusion. 4. Grade ≥3 non-haematological toxicity (except untreated nausea, untreated vomiting, or untreated diarrhoea). 5. Grade ≥2 decrease in cardiac left ventricular function. 6. Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria, or a newly developed decrease in glomerular filtration rate. Toxicity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0
Measured: 3 weeks

Secondary outcomes (19)

The Incidence and Intensity of AEs With Grading According to CTCAE.
The incidence and intensity of adverse events with grading according to CTCAE. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).
Measured: From first drug administration until 28 days after last drug administration, up to 717 days.
Best Overall Response According to RECIST v1.1 Criteria
Best overall response (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) was the best response recorded at any time from the date of the first administration of afatinib or gemcitabine/docetaxel to the end of treatment (EOT). Partial response is for patients with measurable disease. Missing categories signifies that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.
Measured: From first drug administration until 28 days after last drug administration, up to 717 days.
Disease Control According to RECIST v1.1
Disease control according to RECIST v1.1 Disease control is complete response, partial response or stable disease for measurable patients and complete response or non-CR/non-PD for non-measurable patients. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.
Measured: From first drug administration until 28 days after last drug administration, up to 717 days.
Objective Response According to RECIST v1.1
Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.
Measured: From first drug administration until 28 days after last drug administration, up to 717 days.
Time to Objective Response According to RECIST v1.1
Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Time to objective response is the time from the start of treatment to the date of first documented complete response or partial response. Descriptive analyses has been performed for the time to objective response (N(%) of patients with first occurrence of objective response at 6, 12 and 24 weeks). Onset of objective response is derived for patient with measurable disease.
Measured: 6 weeks, 12 weeks and 24 weeks
Duration of Objective Response According to RECIST v1.1
Duration of objective response was the time from the first documented complete response or partial response to disease progression or death.
Measured: From the first documented complete response or partial response to the time of disease progression or death
Duration of Disease Control According to RECIST v1.1
Duration of disease control according to RECIST v1.1.
Measured: From the first administration of study medication to the time of disease progression or death
Progression Free Survival (PFS)
Progression-free survival was defined as the time from the first administration of study medication to the time of disease progression or death, whichever occurred first.
Measured: From the first administration of study medication to the time of disease progression or death
Overall Survival (OS)
Overall survival was defined as the time from the first administration of study medication to the time of death from any cause.
Measured: From the first administration of study medication to the time of death
Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib
Area under the concentration-time curve of Afatinib in plasma over a uniform dosing interval t at steady state.
Measured: PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
Cmax,ss of Afatinib
Maximum concentration of Afatinib in plasma at steady state.
Measured: PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
AUC 0-tz of Gemcitabine
Area under the concentration-time curve of Gemcitabine in plasma over the time interval from 0 up to the last quantifiable data point
Measured: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3
Cmax of Gemcitabine
Maximum concentration of Gemcitabine in plasma.
Measured: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3
Total Clearance (CL) of Gemcitabine
Total Clearance (CL) of Gemcitabine from plasma.
Measured: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3
Volume of Distribution at Steady State (Vss) of Gemcitabine
Apparent volume of distribution at steady state (Vss) of Gemcitabine.
Measured: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3
AUC 0-24 of Docetaxel
Area under the concentration-time curve of docetaxel in plasma over the time interval from 0 up to 24 hours
Measured: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
Cmax of Docetaxel
Maximum concentration of docetaxel in plasma.
Measured: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
Total Clearance (CL) of Docetaxel
Total Clearance (CL) of Docetaxel from plasma.
Measured: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
Volume of Distribution at Steady State (Vss) of Docetaxel
Apparent volume of distribution at steady state (Vss) of Docetaxel.
Measured: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Apr 2015

First posted2 Dec 2010 (estimated)
Study startNov 2010
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01251653
Sponsor's protocol ID: 1200.93
Other IDs: 2010-020560-37
Status last verified: Apr 2016
First submitted: 1 Dec 2010
Last updated: 30 May 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Hiret S, Isambert N, Gomez-Roca C, Bennouna J, Sassi M, de Mont-Serrat H, Fan J, Schnell D, Delord JP. Phase I dose-escalation trial of afatinib, an irreversible ErbB family blocker, in combination with gemcitabine or docetaxel in patients with relapsed or refractory solid tumors. Invest New Drugs. 2018 Dec;36(6):1044-1059. doi: 10.1007/s10637-018-0601-1. Epub 2018 May 29.
PubMed 29808308

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Dose Escalation Trial of Once Daily Oral Treatment Using Afatinib (BIBW2992) Plus Gemcitabine or Docetaxel in Patients With Relapsed or Refractory Solid Tumors.
ClinicalTrials.gov ID: NCT01251653
Acronym / sponsor ID: 1200.93
Conditions: Neoplasms
Study type: Observational
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 2 Dec 2010 (estimated)
Results: Posted 30 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To establish the maximum tolerated dose (MTD) of oral afatinib (BIBW2992) given in combination with gemcitabine or docetaxel in patients with relapsed or refractory tumors.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Afatinib and docetaxel	–	Drug: Afatinib, Drug: docetaxel
Afatinib and gemcitabine	–	Drug: Afatinib, Drug: gemcitabine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: solid tumors

Key inclusion criteria (1 listed)

1. histologically or cytologically confirmed diagnosis of any advanced or metastatic relapsed or refractory solid tumor.

Key exclusion criteria (2 listed)

Active brain metastases
Patients with known pre-existing interstitial lung disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AfatinibMaximum Tolerated Dose of Afatinib in combination with gemcitabine	Drug	Afatinib and docetaxel
AfatinibMaximum Tolerated Dose of Afatinib in combination with gemcitabine	Drug	Afatinib and gemcitabine
docetaxelMaximum Tolerated Dose of Afatinib in combination with docetaxel	Drug	Afatinib and docetaxel
gemcitabineMaximum Tolerated Dose of Afatinib in combination with gemcitabine	Drug	Afatinib and gemcitabine

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).
Time frame: 3 weeks
DLT was based on following criterions: 1. Grade 4 uncomplicated (not associated with fever >38.5° C (Celsius)) neutropenia for ≥7 days. 2. Grade 3 or 4 neutropenia concomitant with fever >38.5º C or Grade ≥3 infection. 3. Platelet count of <25x 10^9/L or <50x 10^9/L with bleeding requiring whole blood transfusion. 4. Grade ≥3 non-haematological toxicity (except untreated nausea, untreated vomiting, or untreated diarrhoea). 5. Grade ≥2 decrease in cardiac left ventricular function. 6. Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria, or a newly developed decrease in glomerular filtration rate. Toxicity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0

19 secondary outcomes

The Incidence and Intensity of AEs With Grading According to CTCAE.
Time frame: From first drug administration until 28 days after last drug administration, up to 717 days.
Best Overall Response According to RECIST v1.1 Criteria
Time frame: From first drug administration until 28 days after last drug administration, up to 717 days.
Disease Control According to RECIST v1.1
Time frame: From first drug administration until 28 days after last drug administration, up to 717 days.
Objective Response According to RECIST v1.1
Time frame: From first drug administration until 28 days after last drug administration, up to 717 days.
Time to Objective Response According to RECIST v1.1
Time frame: 6 weeks, 12 weeks and 24 weeks
Duration of Objective Response According to RECIST v1.1
Time frame: From the first documented complete response or partial response to the time of disease progression or death
Duration of Disease Control According to RECIST v1.1
Time frame: From the first administration of study medication to the time of disease progression or death
Progression Free Survival (PFS)
Time frame: From the first administration of study medication to the time of disease progression or death
Overall Survival (OS)
Time frame: From the first administration of study medication to the time of death
Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib
Time frame: PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
Cmax,ss of Afatinib
Time frame: PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
AUC 0-tz of Gemcitabine
Time frame: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3
Cmax of Gemcitabine
Time frame: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3
Total Clearance (CL) of Gemcitabine
Time frame: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3
Volume of Distribution at Steady State (Vss) of Gemcitabine
Time frame: PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3
AUC 0-24 of Docetaxel
Time frame: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
Cmax of Docetaxel
Time frame: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
Total Clearance (CL) of Docetaxel
Time frame: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55
Volume of Distribution at Steady State (Vss) of Docetaxel
Time frame: PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55

Results and safety

Results posted to the registry on 30 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afatinib 30mg and Gemcitabine 1000mg	3	0
Afatinib 30mg and Gemcitabine 1250mg	8	0
Afatinib 40mg and Gemcitabine 1000mg	20	0
Afatinib 40mg and Gemcitabine 1250mg	6	0
Afatinib 50mg and Gemcitabine 1250mg	2	0
Afatinib 30mg and Docetaxel 60mg	18	0
Afatinib 30mg and Docetaxel 75mg	18	0
Afatinib 40mg and Docetaxel 75mg	12	0
Afatinib 50mg and Docetaxel 75mg	6	0

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).

Time frame: 3 weeks. Number. Unit: Participants

Measure	Afatinib 30mg and Gemcitabine 1000mg n = 3	Afatinib 30mg and Gemcitabine 1250mg n = 8	Afatinib 40mg and Gemcitabine 1000mg n = 20	Afatinib 40mg and Gemcitabine 1250mg n = 6	Afatinib 50mg and Gemcitabine 1250mg n = 2	Afatinib 30mg and Docetaxel 60mg n = 18	Afatinib 30mg and Docetaxel 75mg n = 18	Afatinib 40mg and Docetaxel 75mg n = 12	Afatinib 50mg and Docetaxel 75mg n = 6
Value	0	1	1	2	2	4	6	5	1

Population analysed: Treated Set (TS)

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 28 days after last drug administration, up to 717 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afatinib 30mg and Gemcitabine 1000mg	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Afatinib 30mg and Gemcitabine 1250mg	3 of 8 (37.5%)	8 of 8 (100%)	Not reported
Afatinib 40mg and Gemcitabine 1000mg	12 of 20 (60%)	20 of 20 (100%)	Not reported
Afatinib 40mg and Gemcitabine 1250mg	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
Afatinib 50mg and Gemcitabine 1250mg	2 of 2 (100%)	2 of 2 (100%)	Not reported
Afatinib 30mg and Docetaxel 60mg	7 of 18 (38.9%)	18 of 18 (100%)	Not reported
Afatinib 30mg and Docetaxel 75mg	15 of 18 (83.3%)	18 of 18 (100%)	Not reported
Afatinib 40mg and Docetaxel 75mg	8 of 12 (66.7%)	12 of 12 (100%)	Not reported
Afatinib 50mg and Docetaxel 75mg	6 of 6 (100%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29808308Hiret S, Isambert N, Gomez-Roca C, Bennouna J, Sassi M, de Mont-Serrat H, Fan J, Schnell D, Delord JP. Phase I dose-escalation trial of afatinib, an irreversible ErbB family blocker, in combination with gemcitabine or docetaxel in patients with relapsed or refractory solid tumors. Invest New Drugs. 2018 Dec;36(6):1044-1059. doi: 10.1007/s10637-018-0601-1. Epub 2018 May 29.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms, run by Boehringer Ingelheim at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD). (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01251653, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.