Advanced or Inoperable Malignant Melanoma With BRAF MutationPhase 1NCT01841463

Study of an Oral Cdk Inhibitor Administered With an Oral BRAF Inhibitor in Patients With Advanced or Inoperable Malignant Melanoma With BRAF Mutation

A Phase 1 study testing P1446A-05 and Vemurafenib (Zelboraf®) in people with Advanced or Inoperable Malignant Melanoma With BRAF Mutation, run by Piramal Enterprises Limited at 4 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients with Advanced or Inoperable Malignant Melanoma with BRAF Mutation The primary objective is to determine the safety, maximum tolerated dose (MTD), and dose… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced or Inoperable Malignant Melanoma With BRAF Mutation
What is being tested?: P1446A-05 and Vemurafenib (Zelboraf®)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 4 sitesUnited States
Study dates: Aug 2013to Mar 2016
Phase: Phase 1
Are there results?: None posted in the registry

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

Patients having histologically confirmed unresectable (Stage III) or metastatic (Stage IV) malignant melanoma with a positive BRAF mutation result determined by Roche CoDx or local CLIA-certified analysis
Patients naïve to a selective BRAF inhibitor therapy or must have progressed after therapy on a selective BRAF inhibitor. For patients entering the protocol progressing on vemurafenib therapy, they must be tolerant of the 960 mg po bid dose.
Tumor biopsies are optional in this study except for patients entering the mandatory biopsy cohorts. Nevertheless tumor biopsies are encouraged, especially in patients with accessible tumors for biopsy to include the collection of formalin-fixed, paraffin-embedded (FFPE) and fresh- frozen tissue (FF) as outlined in the biomarker sections of the protocol. Willingness of patient to give consent of biopsy, should be ascertained
Patients of ≥ 18 years of age
Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or1
Patients with measurable disease per 'Response Evaluation Criteria In Solid Tumors' (RECIST version 1.1)

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Patients must have normal organ and adequate marrow function
Patients with ability to swallow and retain oral medication
Women of childbearing potential and men willing to agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the duration of study participation and for at least 4 weeks after withdrawal from the study, unless they are surgically sterilized.
Negative serum pregnancy test within 10 days prior to commencement of therapy dosing in premenopausal women. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year.
Ability to understand and the willingness to offer a written Informed Consent document prior to the screening procedures for participation into the study
For Extension phase-
For patients entering the protocol progressing on vemurafenib therapy, they must be tolerant of the vemurafenib dose selected for the extension phase

Who cannot join

Prior malignancy (within the last 2 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the patient has been disease-free for at least 2 years
Patients who have received any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy (one week for BRAF inhibitor for melanoma) or surgery within 4 weeks (6 weeks for monoclonal antibodies, radioactive monoclonal antibodies or any radio-or toxin-immunoconjugates) before Day 1 of Investigational product administration and have not recovered (to < Grade 1) from the toxic effects from any prior therapy
Patients having received any other investigational agents within 4 weeks prior to Day 1 of Investigational product administration and have not recovered completely (to < Grade 1) from the side effects of the earlier investigational agent
Anticipated administration of any anti-cancer therapies (chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, surgery, and/or tumor embolisation) other than those administered in this study such as BRAF inhibitor
Patients with symptomatic or untreated leptomeningeal or brain metastases, or spinal cord compression [patients with previous brain metastases will be allowed to enter the trial if metastases have been surgically removed or all known sites of metastases have been treated with stereotactic high dose radiosurgery. Patients must be off corticosteroids for at least one month and have a stable lesion with verification by imaging (CT/MRI) within 28 days prior to Day 1 of Investigational product administration]
Patients with clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic diarrheal condition, refractory nausea, vomiting or any other condition that will interfere significantly with the absorption of study drugs

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Patients with mean QTc interval >480 msec at screening
Treatment with drugs with potential to cause dysrhythmias including but not limited to terfenadine, quinidine, procainamide, diisopyramide, sotalol, probucol, bepridil, haloperidol, risperidone and/or indapamide
Patients on warfarin treatment
Any condition for which participation in this study as judged by the Investigator to be detrimental to the patient with (such as) inter-current illness including, but not limited to ongoing or active infection, New York Heart Association functional classification class III, or IV heart failure; unstable angina pectoris; cardiac arrhythmia; history of myocardial infarction; uncontrolled hypertension (blood pressure above 160/100 mm Hg despite antihypertensive treatment); coronary artery bypass graft; cerebrovascular accident; transient ischemic attack or pulmonary embolism during the previous 6 months or psychiatric illness/social situations that would jeopardize compliance with study requirements
Patients with a known immediate or delayed hypersensitivity reaction or idiosyncrasy to any other medication chemically related to P1446A-05 or vemurafenib, or excipients considered to be clinically significant by the investigator
Nursing woman
Patients with known HIV positivity or AIDS- related illness, or active Hepatitis B virus, and active Hepatitis C virus
Patients taking drugs known to prolong the QTc interval who cannot be switched to an alternative drug.
For Extension phase-
Patients with active second malignancy will be eligible as long as they do not need systemic therapy for the second malignancy
Patients with active brain metastases will be included in the study as long as the tumor size is less than 1 cm without the requirement of steroid use for neurological symptoms
Patients with evaluable metastatic disease will be allowed even if there is no measurable disease per RECIST 1.1. In this case patients with many sub centimeter in-transit skin/SQ nodules will be eligible for the biopsy cohort.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
UCSF Medical Center at Mount Zion
South San Francisco, California, 94115
Georgetown-Lombardi Comprehensive Cancer Ctr
Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

Official title: An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered With an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients With Advanced or Inoperable Malignant Melanoma With BRAF Mutation

An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients with Advanced or Inoperable Malignant Melanoma with BRAF Mutation
The primary objective is to determine the safety, maximum tolerated dose (MTD), and dose limiting toxicity (DLT) of the co-administration of P1446A-05 with vemurafenib, in melanoma patients with BRAF mutation

Conditions: Advanced or Inoperable Malignant Melanoma With BRAF Mutation
Being tested: P1446A-05, Vemurafenib (Zelboraf®)
Keywords: Malignant Melanoma
Medical subject headings: Melanoma

What participants receive

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

P1446A-05Drug
- In the 'Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) \& vemurafenib (720, 960 mg bid) in a cohort of 3 to 6 patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. The next higher dose during the dose escalation phase will depend upon demonstrated safety in the previous dose group. The max tolerated dose (MTD) of P1446A-05 \& vemurafenib co-administered will be determined. In the 'Extension' phase, 60 patients with BRAF V600E/K mutations (40 patients naïve to selective BRAF inhibitor therapy, \& 20 progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity to determine efficacy of the co-administration. Additionally, there will be a cohort of 10 patients who consent for mandatory serial tumor biopsy samples \& undergo 'Monotherapy' for 14 days with P1446A-05 at the MTD of the co-administration.
Vemurafenib (Zelboraf®)Drug
- In the 'Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) and vemurafenib (720, 960 mg bid) in a cohort of 3 to 6 patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. Escalation to the next higher dose during the dose escalation phase will depend upon demonstrated safety in the previous dose group. The maximum tolerated dose (MTD) of P1446A-05 and vemurafenib co-administered will be determined.
- In the 'Extension' phase, 60 patients with BRAF V600E/K mutations (40 patients naïve to selective BRAF inhibitor therapy, and 20 progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle
- Additionally, there will be a cohort of 10 patients who consent for mandatory serial tumor biopsy samples and undergo 'Monotherapy' for 14 days with P1446A-05 at the MTD of the co-administration.

Study groups in NCT01841463
Study group	Role	What they receive
P1446A-05	Experimental	* The study will be conducted in two phases- Phase I ('Dose escalation' phase), and Extension phase:- * In the 'Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) and vemurafenib (720, 960 mg bid) in a cohort of three to six patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. * In the 'Extension' phase, sixty patients with BRAF V600E/K mutations (forty patients naïve to selective BRAF inhibitor therapy, and twenty progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity Receives: Drug: P1446A-05; Drug: Vemurafenib (Zelboraf®)

What is being measured

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

Maximum Tolerated Dose and Dose Limiting Toxicity
The study will be conducted in two phases- Phase I (Dose escalation phase), and Extension phase. In the Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) and vemurafenib (720, 960 mg bid) in a cohort of three to six patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. Escalation to the next higher dose during the dose escalation phase will depend upon demonstrated safety in the previous dose group. The maximum tolerated dose (MTD) of P1446A-05 and vemurafenib co-administered will be determined. In the 'Extension' phase, sixty patients with BRAF V600E/K mutations (forty patients naïve to selective BRAF inhibitor therapy, and twenty progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity to determine efficacy of the co-administration.
Measured: Until disease progression or unacceptable toxicity (expected to be 6-8 months)

Secondary outcomes (3)

Tumor Response
- To determine best Overall Response Rate (ORR), Duration of response (DOR), Progression Free Survival (PFS), and Overall Survival (OS) of the co-administration of P1446A 05 and vemurafenib using RECIST version 1.1 in melanoma patients with BRAF mutation
Measured: Until disease progression or unacceptable toxicity (expected to be 6-8 months)
Pharmacokinetic (PK)
- PK parameters such as Cmax, Tmax, AUC0-t, AUC0-inf, Kel, CL, Vz and t1/2 will be determined using standard non-compartmental and population pharmacokinetic approach (wherever possible).
- Blood samples (6 mL at each time point) for pharmacokinetic assessment will be collected at the following time points in Dose Escalation Phase- Cycle 1- Day 15: pre-dose (within 30 min before swallowing the capsule/s, 1, 2, 4, 6, 8hr; Day 19: pre-dose (within 30 min before swallowing the capsule/s, 1, 2, 4, 8hr; and within one hour post dose on Day 22.
- Additionally, blood samples for PK analysis may be collected should patient develop SAE at the earliest feasible time point.
Measured: Cycle1 (Day 15 and 22) and Cycle 2 (Day1,15 and 28)
Biomarker Analysis
- The biomarkers will be assessed pre- and post-treatment and will focus on (a) inhibition of the MAPK pathway as a target of vemurafenib, a RAF inhibitor; (b) cell cycle pathways as an effect of P1446A-05, a Cdk inhibitor; (c) mechanisms of resistance; and (d) markers for senescence and apoptosis as evidence of target engagement/drug response.
- During phase I dose escalation, optional tumor samples will be collected at screening, within 4 to 6 hours of drug administration on Day 14 of Monotherapy and between Cycle 1 Day 15 and Cycle 1 Day 21, and at disease progression
- After the MTD is determined, 10 additional patients will be enrolled in "Serial Tumor biopsy cohort"
- During the Extension phase, tumor samples will be collected at screening, Cycle 1 Day 15 and Cycle 1 Day 21 within 4 to 6 hours of drug administration, and at disease progression.
Measured: Until disease progression or unacceptable toxicity (expected to be 6-8 months)

Timeline

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

Aug 2013Mar 2016

First posted26 Apr 2013 (estimated)
Study startAug 2013
Primary completionMar 2015 (estimated)
Study completionMar 2016 (estimated)

Why it stopped: Sponsor decision not related to patient safety

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced or Inoperable Malignant Melanoma With BRAF MutationStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01841463
Sponsor's protocol ID: P1446A-05/72/12
Status last verified: Sep 2014
First submitted: 17 Apr 2013
Last updated: 4 Sep 2014
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered With an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients With Advanced or Inoperable Malignant Melanoma With BRAF Mutation
ClinicalTrials.gov ID: NCT01841463
Acronym / sponsor ID: P1446A-05/72/12
Conditions: Advanced or Inoperable Malignant Melanoma With BRAF Mutation
Keywords: Malignant Melanoma
Phase: Phase 1
Study type: Interventional
Recruitment status: SuspendedReason stopped: Sponsor decision not related to patient safety
Enrolment: 100 participants (estimated)
Lead sponsor: Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
Collaborators: Melanoma Research Foundation Breakthrough Consortium
Study start: Aug 2013
Primary completion: Mar 2015 (estimated)
Study completion: Mar 2016 (estimated)
First posted: 26 Apr 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

An Open Label, Multicenter, Phase I Extension Study of an Oral Cdk Inhibitor P1446A-05 Administered with an Oral BRAF Inhibitor Vemurafenib (Zelboraf®) in Patients with Advanced or Inoperable Malignant Melanoma with BRAF Mutation
The primary objective is to determine the safety, maximum tolerated dose (MTD), and dose limiting toxicity (DLT) of the co-administration of P1446A-05 with vemurafenib, in melanoma patients with BRAF mutation

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
P1446A-05	Experimental	Drug: P1446A-05, Drug: Vemurafenib (Zelboraf®)* The study will be conducted in two phases- Phase I ('Dose escalation' phase), and Extension phase:- * In the 'Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) and vemurafenib (720, 960 mg bid) in a cohort of three to six patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. * In the 'Extension' phase, sixty patients with BRAF V600E/K mutations (forty patients naïve to selective BRAF inhibitor therapy, and twenty progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity

Who may qualify

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

Key inclusion criteria (13 listed)

Patients having histologically confirmed unresectable (Stage III) or metastatic (Stage IV) malignant melanoma with a positive BRAF mutation result determined by Roche CoDx or local CLIA-certified analysis
Patients naïve to a selective BRAF inhibitor therapy or must have progressed after therapy on a selective BRAF inhibitor. For patients entering the protocol progressing on vemurafenib therapy, they must be tolerant of the 960 mg po bid dose.
Tumor biopsies are optional in this study except for patients entering the mandatory biopsy cohorts. Nevertheless tumor biopsies are encouraged, especially in patients with accessible tumors for biopsy to include the collection of formalin-fixed, paraffin-embedded (FFPE) and fresh- frozen tissue (FF) as outlined in the biomarker sections of the protocol. Willingness of patient to give consent of biopsy, should be ascertained
Patients of ≥ 18 years of age
Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or1

Key exclusion criteria (18 listed)

Prior malignancy (within the last 2 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer or any other cancer for which the patient has been disease-free for at least 2 years
Patients who have received any prior chemotherapy, radiotherapy, biologic/targeted anti-cancer therapy (one week for BRAF inhibitor for melanoma) or surgery within 4 weeks (6 weeks for monoclonal antibodies, radioactive monoclonal antibodies or any radio-or toxin-immunoconjugates) before Day 1 of Investigational product administration and have not recovered (to < Grade 1) from the toxic effects from any prior therapy
Patients having received any other investigational agents within 4 weeks prior to Day 1 of Investigational product administration and have not recovered completely (to < Grade 1) from the side effects of the earlier investigational agent
Anticipated administration of any anti-cancer therapies (chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, surgery, and/or tumor embolisation) other than those administered in this study such as BRAF inhibitor
Patients with symptomatic or untreated leptomeningeal or brain metastases, or spinal cord compression [patients with previous brain metastases will be allowed to enter the trial if metastases have been surgically removed or all known sites of metastases have been treated with stereotactic high dose radiosurgery. Patients must be off corticosteroids for at least one month and have a stable lesion with verification by imaging (CT/MRI) within 28 days prior to Day 1 of Investigational product administration]

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
P1446A-05- In the 'Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) \& vemurafenib (720, 960 mg bid) in a cohort of 3 to 6 patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. The next higher dose during the dose escalation phase will depend upon demonstrated safety in the previous dose group. The max tolerated dose (MTD) of P1446A-05 \& vemurafenib co-administered will be determined. In the 'Extension' phase, 60 patients with BRAF V600E/K mutations (40 patients naïve to selective BRAF inhibitor therapy, \& 20 progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity to determine efficacy of the co-administration. Additionally, there will be a cohort of 10 patients who consent for mandatory serial tumor biopsy samples \& undergo 'Monotherapy' for 14 days with P1446A-05 at the MTD of the co-administration.	Drug	P1446A-05
Vemurafenib (Zelboraf®)* In the 'Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) and vemurafenib (720, 960 mg bid) in a cohort of 3 to 6 patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. Escalation to the next higher dose during the dose escalation phase will depend upon demonstrated safety in the previous dose group. The maximum tolerated dose (MTD) of P1446A-05 and vemurafenib co-administered will be determined. * In the 'Extension' phase, 60 patients with BRAF V600E/K mutations (40 patients naïve to selective BRAF inhibitor therapy, and 20 progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle * Additionally, there will be a cohort of 10 patients who consent for mandatory serial tumor biopsy samples and undergo 'Monotherapy' for 14 days with P1446A-05 at the MTD of the co-administration.	Drug	P1446A-05

Primary outcome

Maximum Tolerated Dose and Dose Limiting Toxicity
Time frame: Until disease progression or unacceptable toxicity (expected to be 6-8 months)
The study will be conducted in two phases- Phase I (Dose escalation phase), and Extension phase. In the Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) and vemurafenib (720, 960 mg bid) in a cohort of three to six patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. Escalation to the next higher dose during the dose escalation phase will depend upon demonstrated safety in the previous dose group. The maximum tolerated dose (MTD) of P1446A-05 and vemurafenib co-administered will be determined. In the 'Extension' phase, sixty patients with BRAF V600E/K mutations (forty patients naïve to selective BRAF inhibitor therapy, and twenty progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity to determine efficacy of the co-administration.

3 secondary outcomes

Tumor Response
Time frame: Until disease progression or unacceptable toxicity (expected to be 6-8 months)
Pharmacokinetic (PK)
Time frame: Cycle1 (Day 15 and 22) and Cycle 2 (Day1,15 and 28)
Biomarker Analysis
Time frame: Until disease progression or unacceptable toxicity (expected to be 6-8 months)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.

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.

Adil Daud, MD principal investigator

UCSF Medical Center at Mount Zion

Kevin B Kim, MD principal investigator

M.D. Anderson Cancer Center

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

Questions about this trial

What is this clinical trial studying?

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 13 inclusion and 18 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: paused, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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.

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?

Results are not available in the source record.

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?

Maximum Tolerated Dose and Dose Limiting Toxicity (time frame: Until disease progression or unacceptable toxicity (expected to be 6-8 months)). 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 NCT01841463.

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 4 Sep 2014.