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Solid TumorsPhase 1NCT00648648

A Dose Escalation Study of Adavosertib (MK-1775) in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adults With Advanced Solid Tumors (MK-1775-001)

A Phase 1 study testing adavosertib, gemcitabine and cisplatin in people with Solid Tumors, run by Merck Sharp & Dohme LLC.

Completed

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

Official record
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Trial summary

This study will investigate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) activity of adavosertib, both as monotherapy and in combination with gemcitabine, cisplatin, or carboplatin in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
adavosertib, gemcitabine and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
No sites listed yet
Study dates
25 Feb 2008to 6 Jan 2014
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

  • Must have a histologically confirmed metastatic or locally advanced solid tumor, progressed despite standard therapy, or for which standard therapy does not exist
  • Must have performance status of <=1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • Female participants must not be pregnant

Who cannot join

  • Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study or who has not recovered from adverse events due to agents given more than 4 weeks earlier
  • Is participating or has participated in a study with an investigational compound or device within 30 days
  • Has active central nervous system (CNS) metastases and/or carcinomatous meningitis. However, participants with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry
  • Has a primary central nervous system tumor
  • Is allergic to any of the components of the combination study therapy or its analogs
  • Participant has had prescription or non-prescription drugs or other products known to be metabolized by Cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication. Medications of particular concern are inhibitors of CYP3A4 (azole antifungals [ketoconazole, itraconazole], macrolide antibiotics [erythromycin, clarithromycin], cimetidine, aprepitant, Human Immunodeficiency Virus (HIV) protease inhibitors, nefrazodone, and the following inducers of CYP3A4: phenytoin, barbiturates and rifampicin, and substrates of CYP3A4 including statins (lovastatin, simvastatin), midazolam, terfenadine, astemizole, and cisapride
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  • Is a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse
  • Pregnant or breastfeeding, or expecting to get pregnant during the time the study will be ongoing
  • HIV-positive
  • History of Hepatitis B or C
  • Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions is eligible
  • Participant must not have prior radiation therapy to more than 30% of the bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy
  • Has had a prior stem cell or bone marrow transplant
  • Has received more than 4 prior cytotoxic chemotherapy regimens
  • Has a history suggestive of Li-Fraumeni Syndrome

About this study

Official title: A Phase I Dose Escalation Study Evaluating MK-1775 in Both Monotherapy and in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adult Subjects With Advanced Solid Tumors

This study will investigate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) activity of adavosertib, both as monotherapy and in combination with gemcitabine, cisplatin, or carboplatin in participants with advanced solid tumors. Dose limiting toxicities (DLT) of adavosertib in combination with gemcitabine, cisplatin, or carboplatin will also be assessed. The primary hypotheses of the study are as follows: 1) Oral administration of adavosertib both as monotherapy and in combination with either gemcitabine, cisplatin, or carboplatin in patients with advanced solid tumors will be safe and tolerable, 2) The side effects observed in participants with advanced solid tumors after administration of adavosertib combined with each of the chemotherapies (gemcitabine, cisplatin and carboplatin) will allow for the definition of a single dose combination Maximum Administered Dose (MAD)/Maximum Tolerated Dose (MTD) and a multiple dose combination Biologically Effective Dose (BED)/MTD for each of the 3 combinations, 3) At a tolerated dose, adavosertib plasma exposure will exceed target thresholds established in preclinical models, and 4) At a tolerated dose, PD markers of adavosertib activity in combination with either gemcitabine, cisplatin, or carboplatin (in surrogate tissue and/or tumor) will meet or exceed the target threshold established in preclinical models.

Read the detailed description

Part 1 consists of single dose adavosertib monotherapy. If well tolerated, participants in Part 1 will continue on to one of three treatment arms in Part 2-A which consists of a single lower dose of adavosertib in combination with standard chemotherapy: 1) Adavosertib +Gemcitabine (1000 mg/m^2), 2) Adavosertib + Cisplatin (75 mg/m^2) or 3) Adavosertib +Carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5). Following completion of Part 2-A, adavosertib will be administered twice daily (BID) for 2.5 days (multi-dose) starting concomitantly with each administration of chemotherapy in Part 2-B. After a preliminary combination MTD of adavosertib and chemotherapy has been established in Part 2B, the MTD confirmation expansion will occur in Part 3.

Conditions
Solid Tumors
Being tested
adavosertib, gemcitabine, cisplatin, carboplatin

What participants receive

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

  • adavosertibDrug

    Also called MK-1775

    adavosertib administered as an oral formulation as either monotherapy or in combination with either gemcitabine, cisplatin, or carboplatin.

  • gemcitabineDrug

    Gemcitabine administered at 1000 mg/m^2 by IV infusion in a 28-day cycle.

  • cisplatinDrug

    Cisplatin administered at 75 mg/m^2 by IV infusion in a 21-day cycle.

  • carboplatinDrug

    Carboplatin administered at AUC/time curve of 5 mg/min/mL (AUC5) by IV infusion in a 21-day cycle.

Study groups in NCT00648648
Study groupRoleWhat they receive
adavosertib 325 mg Single DoseExperimentalParticipants received adavosertib 325 mg, orally, on Day 1.
Receives: Drug: adavosertib
adavosertib 650 mg Single DoseExperimentalParticipants received adavosertib 650 mg, orally, on Day 1.
Receives: Drug: adavosertib
adavosertib 1300 mg Single DoseExperimentalParticipants received adavosertib 1300 mg, orally, on Day 1.
Receives: Drug: adavosertib
adavosertib 100 mg Single Dose + Gemcitabine 1000 mg/m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an intravenous (IV) infusion on Days 1, 8, and 15 in each 4-week cycle plus adavosertib 100 mg single dose, orally, on Day 2 of each cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 200 mg Single Dose + Gemcitabine 1000 mg/m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 in each 4-week cycle plus adavosertib 200 mg single dose, orally, on Day 2 of each cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 100 mg Single Dose + Cisplatin 75 mg/ m^2ExperimentalParticipants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 100 mg single dose orally, on Day 2 of each cycle.
Receives: Drug: adavosertib; Drug: cisplatin
adavosertib 200 mg Single Dose + Cisplatin 75 mg/ m^2ExperimentalParticipants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 200 mg single dose orally, on Day 2 of each cycle.
Receives: Drug: adavosertib; Drug: cisplatin
adavosertib 100 mg Single Dose + Carboplatin AUC 5ExperimentalParticipants received carboplatin at an area under the time curve concentration of 5 mg/min/ml (AUC5) as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 100 mg single dose orally, on Day 2 of each cycle.
Receives: Drug: adavosertib; Drug: carboplatin
adavosertib 200 mg Single Dose + Carboplatin AUC 5ExperimentalParticipants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 200 mg single dose orally, on Day 2 of each cycle.
Receives: Drug: adavosertib; Drug: carboplatin
adavosertib 325 mg Single Dose + Carboplatin AUC 5ExperimentalParticipants received carboplatin AUC5 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 325 mg single dose orally, on Day 2 of each cycle.
Receives: Drug: adavosertib; Drug: carboplatin
adavosertib 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4-week cycle plus adavosertib 25 mg orally twice daily (BID) for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of adavosertib 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus adavosertib 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 doses of adavosertib 25 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an IV infusion given once weekly for 3 consecutive weeks of a 4 week cycle plus adavosertib 50 mg orally BID for 2.5 days, starting concomitantly with the IV infusion of gemcitabine on Day 1 and followed by 4 additional doses of adavosertib 50 mg at approximately 12 hour intervals on Days 1-3, 8-9, and 15-17 of each 4 week cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus adavosertib 100 mg orally once daily (QD) on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus adavosertib 125 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus adavosertib 150 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an IV infusion given on Days 1, 8, and 15 of each 4 week cycle plus adavosertib 175 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2ExperimentalParticipants received gemcitabine 1000 mg/m^2 as an IV infusion on Days 1, 8, and 15 of each 4 week cycle plus adavosertib 200 mg orally QD on Days 1, 2, 8, 9, 15, and 16 of each 4 week cycle.
Receives: Drug: adavosertib; Drug: gemcitabine
adavosertib 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2ExperimentalParticipants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 50 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: cisplatin
adavosertib 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2ExperimentalParticipants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 100 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: cisplatin
adavosertib 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2ExperimentalParticipants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 125 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: cisplatin
adavosertib 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2ExperimentalParticipants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 150 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: cisplatin
adavosertib 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2ExperimentalParticipants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 200 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: cisplatin
adavosertib 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2ExperimentalParticipants received cisplatin 75 mg/ m^2 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 250 mg orally BID for 2.5 days, starting concomitantly with the administration of cisplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: cisplatin
adavosertib 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5ExperimentalParticipants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 75 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: carboplatin
adavosertib 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5ExperimentalParticipants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 150 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: carboplatin
adavosertib 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5ExperimentalParticipants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 225 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: carboplatin
adavosertib 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5ExperimentalParticipants received carboplatin AUC 5 as an IV infusion on Day 1 of each 3 week cycle plus adavosertib 325 mg orally BID for 2.5 days, starting concomitantly with the administration of carboplatin on Day 1 and then at 12 hour intervals on Days 1-3 of each 3 week cycle.
Receives: Drug: adavosertib; Drug: carboplatin

What is being measured

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

  1. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    DLTs were adverse events (AEs) considered at least possibly related to study drug that prevented escalation of the drug dose. Hematologic DLTs were any grade (Gr) 4-5 toxicity EXCEPT: Gr 4 anemia and Gr 4 leukopenia, Gr 4 neutropenia lasting for <7 days, Gr 4 thrombocytopenia lasting for <4 days except if a platelet transfusion is required, and Gr 3/Gr 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment. Non-hematologic DLT was defined as any Gr 3, 4, or 5 non-hematologic toxicity EXCEPT: nausea, vomiting, diarrhea, or dehydration (all Gr 3) occurring in a setting of inadequate compliance with supportive care measures and lasting for <48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, and clinically non-significant, treatable or reversible lab abnormalities including liver function tests, uric acid, etc.

    Measured: Part 1: Up to 14 days, Part 2: Up to 28 days

  2. Percentage of Total Cyclin-dependent Kinase (CDC2)-Positive Cells That Were Phosphorylated (pCDC2) in Skin Cells at Baseline and 8 Hours After MK-1775 Dosing

    The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total CDC2-positive cells that were pCDC2 positive (% pCDC2-positive cells) at baseline and 8 hours after MK-1775 dosing were reported for participants in Part 1, 2-A, and 2-B/3 treatment groups with available data per protocol.

    Measured: Baseline, 8 hours after first MK-1775 dose

  3. Percentage of Total pCDC2 in Skin Cells at Baseline and 24 Hours After MK-1775 Dosing

    The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total pCDC2 at baseline and 24 hours after MK-1775 dosing were reported for participants in the Part 2-B/3 MK-1775 QD x2 Multi Dose plus Gemcitabine treatment groups with available data per protocol.

    Measured: Baseline, 24 hours after first MK-1775 dose

  4. Percentage of Total pCDC2 in Skin Cells at Baseline and 48 Hours After MK-1775 Dosing

    The pCDC2 level in skin cells was used as a marker to evaluate MK-1775 activity. Analysis was done by immunohistochemistry and the percentage of total pCDC2 at baseline and at 48 hours after MK-1775 dosing were reported for participants in the Part 2-B/3 MK-1775 (150 mg, 200 mg, 250) BID x 2.5 Multi Dose plus cisplatin 75 mg/m^2 groups and the 325 mg BID x2.5 Multi Dose + Carboplatin group with available data per protocol.

    Measured: Baseline, 48 hours after first MK-1775 dose

  5. Plasma Concentration of MK-1775 at 8 Hours After Administration (C8hr) of Single or Multiple Oral Doses

    MK-1775 was measured in the plasma at 8 hours after dosing (Day 1 for single dose of monotherapy, Day 2 of single-dose combination therapy and QD x 2 Combination dosing, and Day 3 dose for BID X 2.5 combination dosing) for participants with available data.

    Measured: 8 hours after MK-1775 dose

  6. Mean Urine Excretion of MK-1775 24 Hours After the Day 1 Monotherapy Dose

    The mean cumulative amount of MK-1775 excreted unchanged in urine after a single oral dose was measured during the initial monotherapy cycle of the study. For this outcome measure, samples were collected and analyzed only for the MK-1775 monotherapy arms of the study at defined intervals after the Day 1 dose of monotherapy. Part 2 MK-1775 combination arms were not sampled per protocol.

    Measured: At 0-4 hours, 4-8 hours, and 12-24 hours post Day 1 dose of monotherapy

Secondary outcomes (1)

  1. Best Overall Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

    Best overall response achieved by a participant. Starting at Day 1, participants in Part 2 were evaluated for tumor response every 6-8 weeks until discontinuation from study treatment according to RECIST criteria; which are based on radiographic imaging. Recorded responses were either confirmed by Central Review or unconfirmed (Investigator assessment only), and included complete response (CR; defined as disappearance of all target lesions), partial response (PR; at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD), stable disease (SD; neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD, taking as reference the smallest sum LD since the treatment started), or progressive disease (PD; ≥20% increase in sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions).

    Measured: From Day 1 up through discontinuation of study treatment (up to ~11.2 months)

Timeline

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

  1. First posted1 Apr 2008 (estimated)
  2. Study start25 Feb 2008
  3. Primary completion6 Jan 2014
  4. Study completion6 Jan 2014

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00648648
Sponsor's protocol ID
1775-001
Other IDs
2007_611, MK-1775-001, 2007-005304-40
Status last verified
Aug 2023
First submitted
26 Mar 2008
Last updated
21 Sep 2023
Data monitoring committee
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Leijen S, van Geel RM, Pavlick AC, Tibes R, Rosen L, Razak AR, Lam R, Demuth T, Rose S, Lee MA, Freshwater T, Shumway S, Liang LW, Oza AM, Schellens JH, Shapiro GI. Phase I Study Evaluating WEE1 Inhibitor AZD1775 As Monotherapy and in Combination With Gemcitabine, Cisplatin, or Carboplatin in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Dec 20;34(36):4371-4380. doi: 10.1200/JCO.2016.67.5991. Epub 2016 Oct 31.

    PubMed 27601554

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing adavosertib, gemcitabine and cisplatin in people with Solid Tumors, run by Merck Sharp & Dohme LLC.

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 3 inclusion and 15 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 21 Sep 2023. 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 5 Apr 2019). 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 Experiencing Dose-Limiting Toxicities (DLTs) (time frame: Part 1: Up to 14 days, Part 2: Up to 28 days). The study lists 6 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 NCT00648648, 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 21 Sep 2023.

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