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)

NCT00648648 | Completed Phase 1 Results

• 4 other identifiers: 1775-0012007_611MK-1775-0012007-005304-40
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (6)

• 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.

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

• 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.

  Baseline, 8 hours after first MK-1775 dose

• 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.

  Baseline, 24 hours after first MK-1775 dose

• 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.

  Baseline, 48 hours after first MK-1775 dose

• 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.

  8 hours after MK-1775 dose

• 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.

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

Secondary Outcomes (1)

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

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

Study Arms (28)

adavosertib 325 mg Single Dose

EXPERIMENTAL

Participants received adavosertib 325 mg, orally, on Day 1.

Drug: adavosertib

adavosertib 650 mg Single Dose

EXPERIMENTAL

Participants received adavosertib 650 mg, orally, on Day 1.

Drug: adavosertib

adavosertib 1300 mg Single Dose

EXPERIMENTAL

Participants received adavosertib 1300 mg, orally, on Day 1.

Drug: adavosertib

adavosertib 100 mg Single Dose + Gemcitabine 1000 mg/m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 200 mg Single Dose + Gemcitabine 1000 mg/m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 100 mg Single Dose + Cisplatin 75 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: cisplatin

adavosertib 200 mg Single Dose + Cisplatin 75 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: cisplatin

adavosertib 100 mg Single Dose + Carboplatin AUC 5

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: carboplatin

adavosertib 200 mg Single Dose + Carboplatin AUC 5

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: carboplatin

adavosertib 325 mg Single Dose + Carboplatin AUC 5

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: carboplatin

adavosertib 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: gemcitabine

adavosertib 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: cisplatin

adavosertib 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: cisplatin

adavosertib 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: cisplatin

adavosertib 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: cisplatin

adavosertib 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: cisplatin

adavosertib 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: cisplatin

adavosertib 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: carboplatin

adavosertib 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: carboplatin

adavosertib 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: carboplatin

adavosertib 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5

EXPERIMENTAL

Participants 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.

Drug: adavosertib; Drug: carboplatin

Interventions

adavosertib DRUG

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

Also known as: MK-1775

adavosertib 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2; adavosertib 100 mg Single Dose + Carboplatin AUC 5; adavosertib 100 mg Single Dose + Cisplatin 75 mg/ m^2; adavosertib 100 mg Single Dose + Gemcitabine 1000 mg/m^2; adavosertib 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2; adavosertib 1300 mg Single Dose; adavosertib 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5; adavosertib 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2; adavosertib 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2; adavosertib 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2; adavosertib 200 mg Single Dose + Carboplatin AUC 5; adavosertib 200 mg Single Dose + Cisplatin 75 mg/ m^2; adavosertib 200 mg Single Dose + Gemcitabine 1000 mg/m^2; adavosertib 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5; adavosertib 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2; adavosertib 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5; adavosertib 325 mg Single Dose; adavosertib 325 mg Single Dose + Carboplatin AUC 5; adavosertib 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2; adavosertib 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2; adavosertib 650 mg Single Dose; adavosertib 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5

gemcitabine DRUG

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

adavosertib 100 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2; adavosertib 100 mg Single Dose + Gemcitabine 1000 mg/m^2; adavosertib 125 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2; adavosertib 150 mg QD x2 Multi + Gemcitabine 1000 mg/ m^2; adavosertib 175 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2; adavosertib 200 mg QD x2 Multi Dose + Gemcitabine 1000 mg/ m^2; adavosertib 200 mg Single Dose + Gemcitabine 1000 mg/m^2; adavosertib 25 mg BID x2.5 Multi Dose + Gemcitabine 1000 mg/ m^2; adavosertib 50 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2; adavosertib 50/25 mg BID x2.5 Multi + Gemcitabine 1000 mg/ m^2

cisplatin DRUG

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

adavosertib 100 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 100 mg Single Dose + Cisplatin 75 mg/ m^2; adavosertib 125 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 150 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 200 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 200 mg Single Dose + Cisplatin 75 mg/ m^2; adavosertib 250 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2; adavosertib 50 mg BID x2.5 Multi Dose + Cisplatin 75 mg/ m^2

carboplatin DRUG

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

adavosertib 100 mg Single Dose + Carboplatin AUC 5; adavosertib 150 mg BID x 2.5 Multi Dose + Carboplatin AUC 5; adavosertib 200 mg Single Dose + Carboplatin AUC 5; adavosertib 225 mg BID x2.5 Multi Dose + Carboplatin AUC 5; adavosertib 325 mg BID x2.5 Multi Dose + Carboplatin AUC 5; adavosertib 325 mg Single Dose + Carboplatin AUC 5; adavosertib 75 mg BID x2.5 Multi Dose + Carboplatin AUC 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 27601554 DERIVED

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

adavosertib; Gemcitabine; Cisplatin; Carboplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: April 1, 2008
• Study Start: February 25, 2008
• Primary Completion: January 6, 2014
• Study Completion: January 6, 2014
• Last Updated: September 21, 2023
• Results First Posted: April 5, 2019

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share