Solid CancersPhase 1NCT00968981

A Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

A Phase 1 study testing GDC-0449 in people with Solid Cancers, run by Genentech, Inc..

Completed

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

Trial summary

This is a two stage, Phase Ib study designed to describe the pharmacokinetics of GDC-0449 in patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Cancers
What is being tested?: GDC-0449
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: No sites listed yet
Study dates: Sep 2009to Oct 2010
Phase: Phase 1
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

Who may be able to join

Histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed after first-line and second-line therapy (if there is a second-line therapy that has been shown to provide clinical benefit); patients with basal cell carcinoma will be excluded from this study unless they do not qualify for another open GDC-0449 clinical trial
For patients with disease that is evaluable by physical examination only, diagnosis must also include biomarker confirmation
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Documented negative pregnancy test for women of childbearing potential and agreement to use an effective form of contraception for the duration of the study
Adequate hematopoietic capacity
Adequate hepatic function
Adequate renal function
At least 3 weeks since last chemotherapy, investigational agent, radiation therapy, or major surgical procedure and recovery to pre-treatment baseline or stabilization of all treatment-related toxicities

Who cannot join

Known, untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for ≥ 3 months
Active infection requiring intravenous (IV) antibiotics
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis
Any medical condition or diagnosis that would likely impair absorption of an orally administered drug (e.g., gastrectomy, ileal bypass, chronic diarrhea, gastroparesis)
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
Pregnant or lactating
Treatment with excluded medications, including strong CYP450 inhibitors and inducers

About this study

Official title: A Phase Ib, Open-Label, Dose-Scheduling Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists

Conditions: Solid Cancers
Being tested: GDC-0449
Keywords: Hedgehog, BCC, basal cell carcinoma
Medical subject headings: Carcinoma, Basal Cell

What participants receive

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

GDC-0449Drug
Daily oral repeating dose
GDC-0449Drug
Three times weekly oral repeating dose
GDC-0449Drug
Once weekly oral repeating dose

Study groups in NCT00968981
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: GDC-0449
B	Experimental	Not described Receives: Drug: GDC-0449
C	Experimental	Not described Receives: Drug: GDC-0449

What is being measured

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

Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449
Measured: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Number of Participants With Greater Than (>) 50 Percent (%) Decrease in Trough Concentration at Steady State (Css, Trough)
Percent change = ([trough concentration on Day 15 minus trough concentration on Day 57] divided by trough concentration on Day 15) multiplied by 100.
Measured: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Ratio of Total and Unbound Trough GDC-0449 Concentration Between Day 57 to Day 15
Ratio = trough concentration on Day 57 divided by trough concentration on Day 15. If the ratio of total and unbound trough GDC-0449 concentration between Day 57 to Day 15 is less than 1, then it indicates reduction in total and unbound trough GDC-0449 concentration between Day 15 to Day 57.
Measured: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Plasma Concentration at Steady State (Css) for Total and Unbound GDC-0449
Plasma GDC-0449 concentrations were reported in nanogram per milliliter (ng/mL) units and converted to micromolar (mcM) units using the molecular weight (421.30 grams per mole [g/mol]) prior to PK analysis. Css was calculated for Days 28 to 56.
Measured: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Maximum Plasma Concentration (Cmax) of Total and Unbound GDC-0449
Plasma GDC-0449 concentrations were reported in ng/mL units and converted to mcM units using the molecular weight (421.30 g/mol) prior to PK analysis.
Measured: 0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1, 15 and 57 post-dose
Area Under the Curve From Time Zero to 24 Hour (AUC0-24) for Total and Unbound GDC-0449
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). Below the limit of quantitation (BLQ) values at pre-dose were considered as zero for PK analysis.
Measured: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) for Total and Unbound GDC-0449
AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). BLQ values at pre-dose were considered as zero for PK analysis.
Measured: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Time to Achieve Maximum Observed Plasma Concentration (Tmax) After a Single Dose of GDC-0449
Measured: 0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1

Secondary outcomes (4)

Percentage of Participants With Disease Progression or Death
Disease progression (assessed by Response Evaluation Criteria in Solid Tumors [RECIST]) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing non target lesions.
Measured: Screening, Day 57, and every 8 weeks thereafter up to 52 weeks
Percentage of Participants With a Response by Best Overall Response (BOR)
BOR was defined as the best overall response observed during the treatment period according to RECIST. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Screening Day 57, and every 8 weeks thereafter up to 52 weeks
Progression-Free Survival (PFS) Time
PFS defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by the investigator review of tumor assessments using RECIST, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).
Measured: Screening Day 57, and every 8 weeks thereafter up to 52 weeks
Duration of Response (DR)
DR during first line therapy is defined as the time from when response (complete response [CR] or partial response [PR]) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. CR: disappearance of all target lesions (TLs) with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters. PR: at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum diameters. DR was not calculated as only 1 responding participant reached their response at the last scheduled response assessment, hence follow-up data are not available.
Measured: Screening Day 57, and every 8 weeks thereafter up to 52 weeks

Timeline

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

Sep 2009Oct 2010

First posted31 Aug 2009 (estimated)
Study startSep 2009
Primary completionOct 2010
Study completionOct 2010

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 Solid CancersStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The 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: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00968981
Sponsor's protocol ID: SHH4610g
Status last verified: Jun 2017
First submitted: 28 Aug 2009
Last updated: 11 Jul 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Jia G, Chandriani S, Abbas AR, DePianto DJ, N'Diaye EN, Yaylaoglu MB, Moore HM, Peng I, DeVoss J, Collard HR, Wolters PJ, Egen JG, Arron JR. CXCL14 is a candidate biomarker for Hedgehog signalling in idiopathic pulmonary fibrosis. Thorax. 2017 Sep;72(9):780-787. doi: 10.1136/thoraxjnl-2015-207682. Epub 2017 Mar 1.
PubMed 28250200

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?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Cancers trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib, Open-Label, Dose-Scheduling Study of Hedgehog Pathway Inhibitor GDC-0449 in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists
ClinicalTrials.gov ID: NCT00968981
Acronym / sponsor ID: SHH4610g
Conditions: Solid Cancers
Keywords: Hedgehog, BCC, basal cell carcinoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2009 (actual)
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 31 Aug 2009 (estimated)
Results: Posted 9 Dec 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
A	Experimental	Drug: GDC-0449
B	Experimental	Drug: GDC-0449
C	Experimental	Drug: GDC-0449

Who may qualify

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

Key inclusion criteria (8 listed)

Histologically documented, incurable, locally advanced or metastatic solid malignancy that has progressed after first-line and second-line therapy (if there is a second-line therapy that has been shown to provide clinical benefit); patients with basal cell carcinoma will be excluded from this study unless they do not qualify for another open GDC-0449 clinical trial
For patients with disease that is evaluable by physical examination only, diagnosis must also include biomarker confirmation
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Documented negative pregnancy test for women of childbearing potential and agreement to use an effective form of contraception for the duration of the study
Adequate hematopoietic capacity

Key exclusion criteria (7 listed)

Known, untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for ≥ 3 months
Active infection requiring intravenous (IV) antibiotics
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis
Any medical condition or diagnosis that would likely impair absorption of an orally administered drug (e.g., gastrectomy, ileal bypass, chronic diarrhea, gastroparesis)
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications

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
GDC-0449Daily oral repeating dose	Drug	A
GDC-0449Three times weekly oral repeating dose	Drug	B
GDC-0449Once weekly oral repeating dose	Drug	C

Primary outcome

Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449
Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Number of Participants With Greater Than (>) 50 Percent (%) Decrease in Trough Concentration at Steady State (Css, Trough)
Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Percent change = ([trough concentration on Day 15 minus trough concentration on Day 57] divided by trough concentration on Day 15) multiplied by 100.
Ratio of Total and Unbound Trough GDC-0449 Concentration Between Day 57 to Day 15
Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Ratio = trough concentration on Day 57 divided by trough concentration on Day 15. If the ratio of total and unbound trough GDC-0449 concentration between Day 57 to Day 15 is less than 1, then it indicates reduction in total and unbound trough GDC-0449 concentration between Day 15 to Day 57.
Plasma Concentration at Steady State (Css) for Total and Unbound GDC-0449
Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
Plasma GDC-0449 concentrations were reported in nanogram per milliliter (ng/mL) units and converted to micromolar (mcM) units using the molecular weight (421.30 grams per mole [g/mol]) prior to PK analysis. Css was calculated for Days 28 to 56.
Maximum Plasma Concentration (Cmax) of Total and Unbound GDC-0449
Time frame: 0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1, 15 and 57 post-dose
Plasma GDC-0449 concentrations were reported in ng/mL units and converted to mcM units using the molecular weight (421.30 g/mol) prior to PK analysis.
Area Under the Curve From Time Zero to 24 Hour (AUC0-24) for Total and Unbound GDC-0449
Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). Below the limit of quantitation (BLQ) values at pre-dose were considered as zero for PK analysis.
Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) for Total and Unbound GDC-0449
Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57
AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). BLQ values at pre-dose were considered as zero for PK analysis.
Time to Achieve Maximum Observed Plasma Concentration (Tmax) After a Single Dose of GDC-0449
Time frame: 0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1

4 secondary outcomes

Percentage of Participants With Disease Progression or Death
Time frame: Screening, Day 57, and every 8 weeks thereafter up to 52 weeks
Percentage of Participants With a Response by Best Overall Response (BOR)
Time frame: Screening Day 57, and every 8 weeks thereafter up to 52 weeks
Progression-Free Survival (PFS) Time
Time frame: Screening Day 57, and every 8 weeks thereafter up to 52 weeks
Duration of Response (DR)
Time frame: Screening Day 57, and every 8 weeks thereafter up to 52 weeks

Results and safety

Results posted to the registry on 9 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GDC-0449 150 mg QD	23	1
GDC-0449 150 mg TIW	22	0
GDC-0449 150 mg QW	22	0

Primary outcome: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449

Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57. Median (Full Range). Unit: hours

Measure	GDC-0449 150 mg QD n = 15	GDC-0449 150 mg TIW n = 18	GDC-0449 150 mg QW n = 18
Total: Days 29-36 (n=15,18,18)	24 (1 to 168)	72 (0 to 96)	15 (1 to 96)
Total: Days 50-57 (n=11,13,10)	74 (4 to 164)	74 (4 to 164)	24 (4 to 74)
Unbound; Days 29-36 (n=15, 18, 18)	24 (0 to 168)	6 (0 to 168)	6 (1 to 72)
Unbound: Days 50-57 (n=11,13,10)	104 (4 to 164)	94 (4 to 104)	4 (4 to 74)

Population analysed: The PK Evaluable Population. Number of participants analyzed (N) is equal to (=) participants with baseline and at least one post-baseline assessment for this outcome; n = participants evaluable at specified time-points.

Primary outcome: Number of Participants With Greater Than (>) 50 Percent (%) Decrease in Trough Concentration at Steady State (Css, Trough)

Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57. Number. Unit: participants

Measure	GDC-0449 150 mg QD n = 7	GDC-0449 150 mg TIW n = 13	GDC-0449 150 mg QW n = 9
Total GDC-0449	0	1	4
Unbound GDC-0449	0	6	9

Population analysed: PK Evaluable Population. Here number of participants analyzed (N) = participants with baseline and at least 1 post baseline assessment for this outcome.

Primary outcome: Ratio of Total and Unbound Trough GDC-0449 Concentration Between Day 57 to Day 15

Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57. Mean (Full Range). Unit: ratio

Measure	GDC-0449 150 mg QD n = 7	GDC-0449 150 mg TIW n = 13	GDC-0449 150 mg QW n = 9
Css,trough for Total GDC-0449	1.23 (1.01 to 1.73)	0.87 (0.49 to 1.27)	0.54 (0.47 to 0.66)
Css,trough for Unbound GDC-0449	1.34 (0.96 to 2.21)	0.58 (0.28 to 1.49)	0.20 (0.11 to 0.35)

Population analysed: The PK Evaluable Population. N = participants who completed Day 57 of the study were included in this analysis.

Primary outcome: Plasma Concentration at Steady State (Css) for Total and Unbound GDC-0449

Time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57. Mean (Standard Deviation). Unit: mcM

Measure	GDC-0449 150 mg QD n = 15	GDC-0449 150 mg TIW n = 18	GDC-0449 150 mg QW n = 18
Total GDC-0449	28 (11.4)	26.1 (11.8)	16.9 (5.89)
Unbound GDC-0449	0.163 (0.056)	0.088 (0.0408)	0.0489 (0.0259)

Population analysed: PK Evaluable Population. N = participants with baseline and post baseline data available for measurement of Css at steady state.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signature of informed consent up to 30 days after last dose of study medication (maximum 57 days on study medication).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GDC-0449 150 mg QD	6 of 20 (30%)	19 of 20 (95%)	Not reported
GDC-0449 150 mg TIW	8 of 21 (38.1%)	19 of 21 (90.5%)	Not reported
GDC-0449 150 mg QW	8 of 22 (36.4%)	20 of 22 (90.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28250200Jia G, Chandriani S, Abbas AR, DePianto DJ, N'Diaye EN, Yaylaoglu MB, Moore HM, Peng I, DeVoss J, Collard HR, Wolters PJ, Egen JG, Arron JR. CXCL14 is a candidate biomarker for Hedgehog signalling in idiopathic pulmonary fibrosis. Thorax. 2017 Sep;72(9):780-787. doi: 10.1136/thoraxjnl-2015-207682. Epub 2017 Mar 1.

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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.

Jennifer Low, M.D. study director

Genentech, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GDC-0449 in people with Solid Cancers, run by Genentech, Inc..

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 8 inclusion and 7 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2015). 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?

Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449 (time frame: Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57). The study lists 8 primary outcomes in all. 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 NCT00968981, 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 11 Jul 2017.